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Infectious keratitis associated with contact lens wear: REGINFECOR multicenter study
Queratitis infecciosas asociadas al uso de lentes de contacto: estudio multicéntrico REGINFECOR
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(A) Epithelial ingrowth with fibrous appearance after discontinuation of treatment. (B and C) Anterior segment optical coherence tomography (OCT-SA) where the LASIK scar with epithelial ingrowth is seen at 270 microns in the superficial stroma in the inferotemporal corneal area, not affecting the deep stroma.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "N. Castro Casal, S. Viña Vázquez, S. Romeo Villadóniga" "autores" => array:3 [ 0 => array:2 [ "nombre" => "N." "apellidos" => "Castro Casal" ] 1 => array:2 [ "nombre" => "S." "apellidos" => "Viña Vázquez" ] 2 => array:2 [ "nombre" => "S." 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Rueda-Latorre, J.A. Sosa-Lockward, N. Abreu-Arbaje" "autores" => array:3 [ 0 => array:2 [ "nombre" => "D." "apellidos" => "Rueda-Latorre" ] 1 => array:2 [ "nombre" => "J.A." "apellidos" => "Sosa-Lockward" ] 2 => array:2 [ "nombre" => "N." "apellidos" => "Abreu-Arbaje" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0365669124000583" "doi" => "10.1016/j.oftal.2024.03.008" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0365669124000583?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173579424000690?idApp=UINPBA00004N" "url" => "/21735794/0000009900000006/v1_202406011248/S2173579424000690/v1_202406011248/en/main.assets" ] "en" => array:20 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Review</span>" "titulo" => "Infectious keratitis associated with contact lens wear: REGINFECOR multicenter study" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "237" "paginaFinal" => "247" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "E. Ispizua Mendivil, J.A. Durán de la Colina" "autores" => array:2 [ 0 => array:4 [ "nombre" => "E." "apellidos" => "Ispizua Mendivil" "email" => array:1 [ 0 => "eispizua@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "J.A." "apellidos" => "Durán de la Colina" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Departamento de Oftalmología, Hospital de Urduliz, Urduliz, Bizkaia, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Instituto Clínico Quirúrgico de Oftalmología. Universidad del País Vasco, Bilbao, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "<span class="elsevierStyleItalic">Corresponding author</span>." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Queratitis infecciosas asociadas al uso de lentes de contacto: estudio multicéntrico REGINFECOR" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0020" "etiqueta" => "Fig. 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 1435 "Ancho" => 1508 "Tamanyo" => 88128 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0130" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Distribution of positive cultures.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Contact lenses (CLs) have undergone a significant transformation since the mid-twentieth century, marked by the development of various materials.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> At present, silicone hydrogel CLs are widely used throughout the world as well as in Spain. A notable increase in their adaptation has been observed in recent years, especially for some of their most novel uses, such as myopia control in children and multifocal CLs to address presbyopia.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The prevalence and importance of microbial keratitis (MK) due to CLs is unknown in Spain. It is estimated that there are 1.5–2 million cases of corneal ulcers (all-cause) annually in developing countries.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> In developed countries the incidence of microbial keratitis has been increasing, mainly due to the use of CLs. On average, more than one third of the MKs seen in developed countries are due to CLs, and in these countries, CLs are positioned as the first or second cause of MK.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4–9</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">It is estimated that there are between 60 and 140 million users of CLs worldwide<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10–14</span></a> with a greater number of women in the fourth decade of life. In Spain, about 8% of the population uses CLs on a regular basis.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15–17</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">MK significantly reduces quality of life, especially during the acute phase.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> On the other hand, it represents a considerable economic burden, with numerous medical consultations and associated direct costs.<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9,19</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">A large majority of CLs wearers exhibit risk behaviors for corneal infection<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">14,20</span></a> usually with low risk perception and no recollection of having received any message from their optician or ophthalmologist about recommendations on CLs management.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The main objective of the REGINFECOR study was to obtain a sociodemographic view of MK associated with the use of CLs in Spain to study its incidence, microbiological profile, risk factors and sequelae related to its development in order to understand the characteristics of this type of infection in Spain. In this article we present the most relevant results of the study.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The study was structured as a multicenter prospective, descriptive and observational epidemiological study with a duration of one year in each center. Of the 37 centers invited to participate, 5 centers were unable to provide any patients meeting the criteria. The complete list of participating centers can be found in the results section.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The recruitment date for the first hospitals was July 6, 2020 (Torrejón Hospital, Ramón y Cajal Hospital and the University Clinic Hospital of Valencia). The recruitment period was opened progressively (as the relevant permits were obtained), lasting one year, with the last center to join being the Marqués de Valdecilla Hospital, on August 25, 2021. Therefore, the last center to complete recruitment was the Marqués de Valdecilla Hospital in August 2022.</p><p id="par0045" class="elsevierStylePara elsevierViewall">An additional one-year period was established in order to be able to complete the database with sequelae of patients with longer disease. Inclusion criteria were as follows: patients<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>6 years old, CLs users, diagnosed with infectious keratitis (according to the following criteria: corneal infiltrate of onset during CLs use and/or specific signs of infection, such as purulent discharge, hypopyon, perineuritis. Among others) and with acceptance of informed consent. Exclusion criteria were: the use of therapeutic CLs and patients undergoing corneal surgery or with previous corneal pathology, except keratoconus.</p><p id="par0050" class="elsevierStylePara elsevierViewall">The patients were referred from the emergency services of each center to the ophthalmology department. Once the patient/legal representative had understood everything about the study, and if he/she agreed, consent was given by signing the informed consent document.</p><p id="par0055" class="elsevierStylePara elsevierViewall">No biological samples were collected outside of standard practice; therefore, all microbiological cultures collected fall within the standard practice of each center. However, the principal investigators were informed about the importance of taking a culture whenever possible. If corneal collection was not deemed appropriate, it was advised to culture liquid or CLs case.</p><p id="par0060" class="elsevierStylePara elsevierViewall">The results were added to a coded, restricted access database for subsequent statistical analysis.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Categorical variables are described by frequency tables and percentages, and categorical variables are described by mean and standard deviation or median and interquartile range, depending on the distributional characteristics.</p><p id="par0070" class="elsevierStylePara elsevierViewall">Multivariate logistic regression models were used to analyze the risk factors associated with infectious keratitis. The results are expressed as odds ratio (OR) and 95% confidence interval. Statistical analysis was performed with SPSS v.23.0 statistical software.</p><p id="par0075" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> shows a copy of the form that was given to patients to fill out in the emergency room.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0080" class="elsevierStylePara elsevierViewall">From the point of view of data analysis, a sample size calculation does not apply, since it is an epidemiological study in which the aim is to study the factors associated with corneal infection. As many patients were included as were recruited during the year of recruitment.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Demographics</span><p id="par0340" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0085" class="elsevierStylePara elsevierViewall">A total of 304 cases (affected eyes) were collected from 293 patients from 32 hospitals. Five centers were unable to contribute patients. The start date for patient recruitment from the first hospitals was July 6, 2020. Case recruitment ended in August 2022.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0090" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a> shows the number of cases (eyes) reported by each hospital center. Madrid, Valencia and Vizcaya were the autonomous communities with the highest number of cases. Madrid, probably due to its population and the number of hospitals involved.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Valencia also has a large number of cases per center. Finally, Vizcaya, despite being a small territory, also had a significant number of cases. The centers in the study were numerous compared to other areas,<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> and the investigators, being a study of their area, may have been more involved.</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0095" class="elsevierStylePara elsevierViewall">Infectious keratitis associated with CLs use affects mostly young patients; the median age was 32.7 years (RIC of 25.4–46), and the proportion of females was 59%.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">-</span><p id="par0100" class="elsevierStylePara elsevierViewall">Both eyes were affected in similar proportions (49.1% right eye and 47.8% left eye). Of special interest are the 9 cases (3.07%) in which the involvement was bilateral. These were cases with simultaneous involvement, which were left with hardly any sequelae, all with good vision, and cure in less than 3 weeks, except for one case, with a duration of 7 weeks and good outcome, and another very severe case, with important bilateral sequelae, caused by different (and not concurrent) bacteria in an ADVP patient.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">-</span><p id="par0105" class="elsevierStylePara elsevierViewall">In 5 of these cases negative cultures were obtained, which leads us to think that they could be cases with inflammation of non-infectious origin. Others had no indication of culture, so it can be assumed they involved mild cases.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">-</span><p id="par0110" class="elsevierStylePara elsevierViewall">It was observed that during the summer months there was a statistically significant increase in the influx of patients to the emergency department.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">-</span><p id="par0115" class="elsevierStylePara elsevierViewall">The number of patients with atopy was 34, accounting for 11.7% of cases, similar to the data available for the general population. There were only 7 patients with immunosuppressive treatment, with very heterogeneous drugs and different degrees of immune system suppression, which makes it difficult to draw conclusions in this regard.</p></li></ul></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">About contact lenses</span><p id="par0345" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">-</span><p id="par0120" class="elsevierStylePara elsevierViewall">The type of CLs most commonly used in our results is soft CLs (96%), with monthly replacement (76%) and cleaning with a single solution (92.4%). It should be noted that the number of patients using disposable CLs in our results (13.6%) is much lower than the sales reported by the companies, which suggests that these patients may suffer fewer infections, as suggested by some studies.</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">-</span><p id="par0125" class="elsevierStylePara elsevierViewall">Nocturnal wearing of CLs was found in 3.29% of patients, 6 with orthokeratology and 4 with continuous wearing.</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">-</span><p id="par0130" class="elsevierStylePara elsevierViewall">Fitting (90.4%) and purchase (88.7%) are routinely performed in optical establishments.</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">-</span><p id="par0135" class="elsevierStylePara elsevierViewall">The median age of initiation of CLs use was 18<span class="elsevierStyleHsp" style=""></span>years (interquartile range [IQR]: 15–25).</p></li></ul></p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Risk factors</span><p id="par0350" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">-</span><p id="par0140" class="elsevierStylePara elsevierViewall">Several risk factors related to CLs use were analyzed, such as repeated use of the same solution, lengthening the shelf life, hand washing, sleeping with CLs, swimming with CLs, showering with CLs, using tap water or saline to store CLs. Most patients had several risk factors (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>).</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">-</span><p id="par0145" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Topping off</span>, or repeating the use of the same solution, was observed in approximately half of the patients (50.4%).</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">-</span><p id="par0150" class="elsevierStylePara elsevierViewall">68% of patients admitted to extending the life of the CLs.</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">-</span><p id="par0155" class="elsevierStylePara elsevierViewall">The majority (74.1%) washed their hands before handling CLs, which was interpreted as a protective factor.</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">-</span><p id="par0160" class="elsevierStylePara elsevierViewall">More than half (54.4%) admitted sleeping with the CLs, swimming (52.3%), or showering with the CLs (67.6%). Seven percent used tap water and 17.4% used saline for CLs maintenance on an occasional or regular basis.</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">-</span><p id="par0165" class="elsevierStylePara elsevierViewall">The presence of these risk practices is not related to age or the number of years of CLs use.</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">-</span><p id="par0170" class="elsevierStylePara elsevierViewall">Nocturnal carrying of CLs was associated with a higher incidence of leukomas (moderate or severe), with an OR of 4.87 (95% confidence interval [CI]: 1.26–18.8; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05).</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Microbiology</span><p id="par0355" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">-</span><p id="par0175" class="elsevierStylePara elsevierViewall">Cultures were taken from various areas, with the following distribution: corneal (65.3%), more than one source (20.2%), lacrimal fluid (CLs) (6.6%), case (4.1%) and liquid (3.3%). Of these cultures, 163 were positive, while 96 were negative. Therefore, it should be noted that negative cultures are frequent (37.06%), which sometimes hinders the therapeutic approach.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">-</span><p id="par0180" class="elsevierStylePara elsevierViewall">The vast majority of the cultures taken were positive for bacteria (84.04% of the positive cultures), with the group of gram-negative bacteria being of note (68.6% of the bacteria), and among them, <span class="elsevierStyleItalic">Pseudomonas aeruginosa</span> was the most repeated, with 66 cases (<a class="elsevierStyleCrossRefs" href="#fig0020">Figs. 4 and 5</a>). Of the total number of cultures, 25.48% were positive for <span class="elsevierStyleItalic">Pseudomonas</span> spp). Its presence implied a greater severity of sequelae, with the appearance of more moderate or severe leukomas, with an OR of 4.43 (CI<span class="elsevierStyleHsp" style=""></span>95%: 2.33–8.46; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05). It also statistically significantly increased the need for corneal transplantation, with an OR of 3.82 (CI<span class="elsevierStyleHsp" style=""></span>95%: 1.24–11.8; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05).</p><elsevierMultimedia ident="fig0020"></elsevierMultimedia><elsevierMultimedia ident="fig0025"></elsevierMultimedia></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">-</span><p id="par0185" class="elsevierStylePara elsevierViewall">Slightly lower numbers than in other studies have been reported for <span class="elsevierStyleItalic">Acanthamoeba (</span>9 cases, 5.52% of positive cultures) and fungi (5 cases, 3.06% of positive cultures). Cultures positive for multiple germs (polymicrobial) are common (7.36% of positive cultures).</p></li></ul></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Sequels</span><p id="par0360" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">-</span><p id="par0190" class="elsevierStylePara elsevierViewall">Most cases have turned out to be benign, with good final visual acuity and no sequelae or only a mild leukoma with little visual impact.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">-</span><p id="par0195" class="elsevierStylePara elsevierViewall">The median final decimal visual acuity (VA) was 1.0, although some patients presented very low final visions, reaching 0.05 or even perception of light. It is relevant to note that no patient required enucleation due to loss of eyeball integrity. Six percent of patients experienced final visions of 0.2 or lower, while the vast majority maintained visions equal to or greater than 0.5 on the decimal VA scale. It was observed that final VA did not show a statistically significant relationship with poor contact lens wearing habits nor with the isolated habit of sleeping with contact lenses. Patients with worse visions were proposed for corneal transplantation, and it was recorded that the median final decimal VA of patients before considering or performing a transplantation was 0.15.</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">-</span><p id="par0200" class="elsevierStylePara elsevierViewall">In order to facilitate the interpretation of the results and statistical analyses, leukomas were grouped according to the characteristics described by the investigators and according to the level of VA. In addition to the investigator's description of the leukoma, it was considered as follows:<ul class="elsevierStyleList" id="lis0030"><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">o</span><p id="par0205" class="elsevierStylePara elsevierViewall">Mild leukoma if VA 0.8 or better.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">o</span><p id="par0210" class="elsevierStylePara elsevierViewall">Moderate leukoma: 0.6−0.7 (both included).</p></li><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">o</span><p id="par0215" class="elsevierStylePara elsevierViewall">Severe leukoma: 0.5 or worse.</p></li></ul></p></li><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">-</span><p id="par0220" class="elsevierStylePara elsevierViewall">A total of 32 patients (11.15%) experienced severe leukomas, which had a significant impact on visual acuity and visual quality. Both nocturnal contact lens wear (OR: 4.87; CI<span class="elsevierStyleHsp" style=""></span>95%: 1.26–18.8; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05) and the presence of <span class="elsevierStyleItalic">Pseudomonas</span> spp. (OR: 4.43; CI<span class="elsevierStyleHsp" style=""></span>95%: 2.33–8.46; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05) were associated with a higher incidence of moderate or severe leukomas), as previously discussed.</p></li><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">-</span><p id="par0225" class="elsevierStylePara elsevierViewall">2.37% of the patients had a corneal transplant (7 patients), and the same percentage (7 others) were waiting for one. Among the transplants performed, several had a fungus involved, which not infrequently leads to undelayable “hot” keratoplasties.</p></li><li class="elsevierStyleListItem" id="lsti0150"><span class="elsevierStyleLabel">-</span><p id="par0230" class="elsevierStylePara elsevierViewall">There was only one case of endophthalmitis, caused by a filamentous fungus <span class="elsevierStyleItalic">(Fusarium verticilloides)</span>.</p></li><li class="elsevierStyleListItem" id="lsti0155"><span class="elsevierStyleLabel">-</span><p id="par0235" class="elsevierStylePara elsevierViewall">The time to cure of infectious activity was 3 weeks (median: 3; RIC: 2–4) in our sample, but can be extended for months. Specifically, the time to cure for patients with <span class="elsevierStyleItalic">Acanthamoeba</span> was by far the longest (14 weeks median), followed by fungal MK (7 weeks median) (<a class="elsevierStyleCrossRef" href="#fig0030">Fig. 6</a>).</p><elsevierMultimedia ident="fig0030"></elsevierMultimedia></li></ul></p><p id="par0240" class="elsevierStylePara elsevierViewall">Once these results are known, we must interpret and place them in a context. In this segment, we will explore the implications of our findings in light of the existing literature, analyzing possible correlations, challenges and significant contributions to understanding and addressing this issue. In addition, we will address study limitations and offer recommendations for future research, with the goal of enriching the knowledge base and optimizing clinical care in the field of contact lens-related corneal infections.</p><p id="par0245" class="elsevierStylePara elsevierViewall">During the development of this work, several limitations have been identified that require consideration. First, the multicenter nature of the study has introduced the possibility of loss of information, as some initial centers did not respond or participate in the study despite efforts to involve them. In addition, a disparity was observed in the number of cases registered in different regions of Spain such as Madrid, Valencia and Vizcaya, due to the variability in the number of centers contacted in each area, with a particular concentration in Madrid and Vizcaya. This asymmetry in the geographical distribution of cases may influence the results.</p><p id="par0250" class="elsevierStylePara elsevierViewall">The heterogeneity of the microbiological results and the lack of a standardized sampling protocol made statistical analysis difficult. In addition, the collection of information on resistance through antibiograms was not possible due to the need to keep the questionnaire simple for both patients and physicians, with the aim of obtaining complete data. Some questions in the questionnaire were asked in an unclear manner, especially those related to the frequency of risk practices, which may have led to over- or underestimation of these practices.</p><p id="par0255" class="elsevierStylePara elsevierViewall">The questionnaire also lacked details on other risk factors and sequelae, as the aim was not to overburden physicians or discourage their participation. The sequelae were grouped according to vision criteria and visual acuity level, which limits the ability to relate visual acuity and cataract. Conducting the study during the pandemic may have limited access to EDs and decreased routine contact lens wear by the general population, as new fittings were reduced. In addition, there was a decrease in contact lens wear during the onset of the pandemic and an increase in the tendency to use disposable lenses.<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">22–24</span></a> These limitations highlight the importance of interpreting the results with caution and considering the context in which the study was conducted.</p><p id="par0260" class="elsevierStylePara elsevierViewall">Knowing the approximate population served by each hospital, we have calculated an average incidence of 0.327 cases of infectious keratitis per 10,000 inhabitants per year, i.e., approximately 1 case per 30,000 inhabitants per year.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a> This, considering an 8% population of CLs users in Spain,<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">26,27</span></a> means 4 cases per 10,000 CLs users per year, which is not far from the figures provided by other studies: the estimated annual incidence of MK in CLs users in the United States is 13/10,000 persons per year,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> but values ranging from 0.36 to 4.2/10,000 CLs users have been described in various studies.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,5,28–30</span></a></p><p id="par0265" class="elsevierStylePara elsevierViewall">With a view to future preventive strategies, iIt is important to highlight that the majority of spectacle lens wearers, in all studies, show at least one risk behavior for corneal infection,<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9,14</span></a> which is also evident among our patients in Spain. One of the most widely recognized risk behaviors, which has also been reflected in our study, is the extended and nocturnal use of CLs, which significantly increases the risk, according to the literature,<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,28,31</span></a> and with a higher proportion of moderate and severe leukomas in our patients.</p><p id="par0270" class="elsevierStylePara elsevierViewall">We know that CL MKs do not depend exclusively on compliance with hygienic measures, but also on loss of ocular surface homeostasis, but devoting our efforts in prevention to improving compliance with hygienic measures seems relatively straightforward and affordable.</p><p id="par0275" class="elsevierStylePara elsevierViewall">Although the industry that sells CLs is not interested in advertising their potential risks, and opticians may also have a conflict of interest, perhaps it should be the job of the ophthalmic physician to instruct on the proper use of CLs consistently to all their patient users in the practice, even if the reason for consultation is not MK. It should even be raised whether it may be important or necessary to sign an informed consent before initiating the use of CLs, during fitting in opticians' practices, so that patients always have the information available before starting their use.</p><p id="par0280" class="elsevierStylePara elsevierViewall">MK of amebic, fungal or polymicrobial origin is complicated to diagnose and has a rapid course, so it is vital to suspect it early in order to start treatment as soon as possible. In all cases of severe MK it is essential to refer the patient to a corneal and anterior segment specialist. It should be taken into account for empirical treatment that when studies refer solely and exclusively to keratitis caused by the use of CLs, the microbiology is inverted, being more common to find a majority of gram-negatives as opposed to gram-positives, as we have been able to reaffirm in our study.<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">32</span></a></p><p id="par0285" class="elsevierStylePara elsevierViewall">It is essential to highlight that fourth generation fluoroquinolones, such as moxifloxacin, are less effective against <span class="elsevierStyleItalic">Pseudomonas in</span> CLs carriers and are therefore not recommended, given the enormous importance of this microorganism in this context.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0290" class="elsevierStylePara elsevierViewall">Finally, for the future, we should investigate microbial resistances and molecular mechanisms involved in the pathogenesis of CLs MK to improve treatments.</p><p id="par0295" class="elsevierStylePara elsevierViewall">To conclude, we will break down the conclusions obtained in this REGINFECOR study, providing epidemiological information on infectious keratitis associated with contact lens wear in Spain.</p><p id="par0300" class="elsevierStylePara elsevierViewall">In Spain, infectious keratitis associated with the use of spectacle lenses affects mainly young women and in summer. The most commonly used type of CL is the soft CL, with monthly replacement and cleaning with a single solution. Fitting and purchase are usually carried out in opticians' stores. The presence of risk factors for developing infectious keratitis is common, and most cases have been found to be benign. Nighttime wearing of CLs has been related to a higher incidence of leukomas (moderate or severe). In microbiology, the gram-negative group stands out, and among them, <span class="elsevierStyleItalic">Pseudomonas aeruginosa</span>. Their presence has led to greater severity in leukomas, as well as the need for corneal transplantation. Negative cultures are frequent. The time to cure the infectious activity is long, which can be a major problem for these patients of working age. Finally, we have estimated an approximate figure of 1 case per 30,000 inhabitants per year of MK due to CLs in Spain, which is not far from other estimates in similar studies (assuming an 8% population of CLs users, this means 4 cases per 10,000 users).</p><p id="par0305" class="elsevierStylePara elsevierViewall">Early suspicion and initiation of treatment in cases of infectious keratitis caused by amoebae, fungi or polymicrobial cultures is important due to its complicated diagnosis and torpid course. We should think about the importance of educating patients about the risks associated with poor habits of CLs use to prevent avoidable cases. It would be important to investigate in the future the microbial resistances and molecular mechanisms involved in CLs-related infectious keratitis.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Ethical considerations</span><p id="par0310" class="elsevierStylePara elsevierViewall">The study was conducted in accordance with international Good Clinical Practice standards, the Declaration of Helsinki in its latest active amendment, and international and national standards and regulations, and was not initiated until approval had been obtained from the CEIC of Euskadi and the Director of said Institution. The study was also approved by all the CEICs of each hospital center involved. Any modification of this protocol was reviewed and approved by the sponsor and was evaluated by the CEIC for approval before including subjects in a modified protocol.</p><p id="par0315" class="elsevierStylePara elsevierViewall">The study was conducted according to Organic Law 3/2018, of December 5, on Personal Data Protection and guarantee of digital rights with regard to data processing, and no data allowing the personal identification of the subjects was included, the information being managed under encryption.</p><p id="par0320" class="elsevierStylePara elsevierViewall">Patients were informed orally and in writing about all the information related to the study and adapted to their level of understanding. A copy of the consent form and information sheet was provided to the patient.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Funding</span><p id="par0325" class="elsevierStylePara elsevierViewall">This study has received a financial grant from the Ophthalmology Society of Spain for study design, analysis and interpretation of the data.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflict of interest</span><p id="par0330" class="elsevierStylePara elsevierViewall">No conflicts of interest were declared by the authors.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:14 [ 0 => array:3 [ "identificador" => "xres2157675" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1830883" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2157676" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1830882" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Demographics" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "About contact lenses" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Risk factors" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Microbiology" ] 8 => array:2 [ "identificador" => "sec0025" "titulo" => "Sequels" ] 9 => array:2 [ "identificador" => "sec0030" "titulo" => "Ethical considerations" ] 10 => array:2 [ "identificador" => "sec0035" "titulo" => "Funding" ] 11 => array:2 [ "identificador" => "sec0040" "titulo" => "Conflict of interest" ] 12 => array:2 [ "identificador" => "xack748783" "titulo" => "Acknowledgments" ] 13 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-12-19" "fechaAceptado" => "2024-01-27" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1830883" "palabras" => array:5 [ 0 => "Infectious keratitis" 1 => "Contact lenses" 2 => "Microbiology" 3 => "Epidemiology" 4 => "<span class="elsevierStyleItalic">Pseudomonas aeruginosa</span>" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1830882" "palabras" => array:5 [ 0 => "Queratitis infecciosas" 1 => "Lentes de contacto" 2 => "Microbiología" 3 => "Epidemiología" 4 => "<span class="elsevierStyleItalic">Pseudomonas aeruginosa</span>" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">This 32-centre multicentre study addresses the lack of knowledge about the prevalence and significance of microbial keratitis (MK) associated with contact lens (CL) wear in Spain. A total of 304 cases recruited from 32 hospitals were studied and showed that infectious keratitis associated with contact lens wear mainly affects young women during the summer months. In this study, soft lenses with monthly replacement and single solution cleaning were most commonly used, purchased and fitted in opticians' shops. Common risk factors were identified among users, such as topping off solutions, prolonging the life of lenses, and frequently sleeping, swimming and showering with lenses. Overnight lens wear was significantly associated with a higher incidence of corneal opacities, and the presence of Pseudomonas aeruginosa in bacterial cultures was associated with more severe sequelae and a greater need for corneal transplantation. Although most cases were benign, the time taken to heal was long, which poses a problem for working patients. This study provides valuable epidemiological, microbiological and risk factor information and estimates the incidence of CL related MK in Spain to be approximately 1 case per 30,000 inhabitants per year.</p></span>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Este estudio multicéntrico, realizado en 32 centros, aborda la falta de conocimiento sobre la prevalencia y relevancia de las queratitis microbianas (QM) asociadas al uso de lentes de contacto (LC) en España. Se examinaron 304 casos reclutados de 32 hospitales, revelando que la queratitis infecciosa asociada al uso de LC afecta principalmente a jóvenes mujeres durante los meses de verano. En este estudio, las LC blandas, de recambio mensual y limpieza con solución única, son las más utilizadas, siendo adquiridas y adaptadas en establecimientos de óptica. Se identificaron factores de riesgo comunes entre los usuarios, como la reutilización de soluciones desinfectantes, el alargamiento de la vida útil de las LC y prácticas habituales de sueño, natación y ducha con ellas. El uso nocturno de LC se asoció significativamente con una mayor incidencia de leucomas, y se observó que la presencia de Pseudomonas aeruginosa en los cultivos bacterianos se relacionó con secuelas más graves y mayor necesidad de trasplante de córnea. A pesar de la mayoría de los casos fueron benignos, el tiempo de curación fue extenso, planteando problemas para los pacientes en edad laboral. Este estudio proporciona valiosa información epidemiológica, microbiológica y de factores de riesgo, estimando una incidencia aproximada de 1 caso por cada 30,000 habitantes al año de QM por LC en España.</p></span>" ] ] "multimedia" => array:6 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:3 [ 0 => array:1 [ "imagen" => "gr1a.jpeg" ] 1 => array:1 [ "imagen" => "gr1b.jpeg" ] 2 => array:1 [ "imagen" => "gr1c.jpeg" ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0115" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Form given to patients to fill out in the emergency room and subsequently filled out by the investigators.</p>" ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 4175 "Ancho" => 1659 "Tamanyo" => 525463 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0120" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Number of cases reported by each center and the code used to register the cases.</p>" ] ] 2 => array:8 [ "identificador" => "fig0015" "etiqueta" => "Fig. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1255 "Ancho" => 1675 "Tamanyo" => 112348 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0125" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Frequency (in percent) of each risk habit among the surveyed patients.</p>" ] ] 3 => array:8 [ "identificador" => "fig0020" "etiqueta" => "Fig. 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 1435 "Ancho" => 1508 "Tamanyo" => 88128 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0130" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Distribution of positive cultures.</p>" ] ] 4 => array:8 [ "identificador" => "fig0025" "etiqueta" => "Fig. 5" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr5.jpeg" "Alto" => 960 "Ancho" => 1508 "Tamanyo" => 56735 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0135" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Distribution of positive cultures for bacteria, with a majority of gram-negative cultures.</p>" ] ] 5 => array:8 [ "identificador" => "fig0030" "etiqueta" => "Fig. 6" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr6.jpeg" "Alto" => 1420 "Ancho" => 1508 "Tamanyo" => 119990 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0140" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Median time to cure of infectious activity measured in weeks, distribution according to microbiological group.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:32 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Complicaciones de las lentes de contacto" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J.A. 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Ares, Eduardo Jerez, Julio Pérez, Laura Fernández del Cotero, Isabel Guedes, Juan Pablo Espinoza González, Leticia Siguero Martín, Pedro Arriola, Isabel Collado, Lidia Medina Ramírez, Antonio J. Mateo Orobia, Gloria Lucas, Ana Boto, Isabel Mogollon, Azucena Baeza, Nuria Ramírez Lillo, Jorge Gaitán, Carmen Revuelta, Andrea Cervero, Nora Muruzabal, Iker Otxoa, Idoia Bearán, Sandra Pérez, Felipe Costales, Álvaro Arjonilla, Pablo Rivera, José Antonio Zumieta, Mariana Benedi, Naroa Moreno, Andrea Aranburu, Raquel Adrados and Iker Henares, and to the Sociedad Española de Oftalmología.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/21735794/0000009900000006/v1_202406011248/S2173579424000562/v1_202406011248/en/main.assets" "Apartado" => array:4 [ "identificador" => "5815" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Review" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/21735794/0000009900000006/v1_202406011248/S2173579424000562/v1_202406011248/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173579424000562?idApp=UINPBA00004N" ]
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