Are the epi-on and epi-off CXL protocols equivalent in the treatment of keratoconus?

D’Oria, F.; Alio, J.L.

doi:10.1016/j.oftale.2022.01.002

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(A) Standardised mean differences of change in uncorrected distance visual acuity (UDVA). (B) Standardised mean differences in change in corrected distance visual acuity (CDVA)." ] ] ] "textoCompleto" => "Keratoconus is a progressive ectatic corneal disorder that affects about 1 in 2000 people. With astigmatism becoming increasingly irregular, it is often necessary to wear rigid contact lenses until intracorneal rings are needed for visual rehabilitation.<a class="elsevierStyleCrossRefs" href="#bib0005">1,2</a> In extreme cases, patients with advanced keratoconus require corneal transplantation, such as deep anterior lamellar keratoplasty or penetrating keratoplasty.<a class="elsevierStyleCrossRef" href="#bib0015">3</a> Corneal cross-linking (CXL) has significantly changed the treatment of patients with keratoconus. Since its introduction, several variants of the standard epi-off CXL procedure have been proposed aimed at avoiding epithelial debridement and increasing patient comfort and safety.<a class="elsevierStyleCrossRef" href="#bib0020">4</a> However, there is a paucity of studies that have been designed to answer the clinical question of the relative benefit of these procedures, and disagreement between the epi-on CXL protocols used in the different randomised clinical trials (RCTs) has led to a lack of definitive evidence.Therefore, our study group has conducted a meta-analysis for scientific methodology to overcome this limitation and compare epi-on versus epi-off CXL protocols to halt keratoconus progression.<a class="elsevierStyleCrossRef" href="#bib0025">5</a> This study identified 1102 publications after a systematic literature search; after eliminating duplicates, 44 potentially relevant articles were identified and accessed in full text, finally including 15 articles.The review conducted by said study group considered, as a primary outcome, the average flattening of Kmax, changes in uncorrected (UDVA) and corrected (CDVA) distance visual acuity, changes in higher order aberrations and chromatic aberrations, and the depth of the demarcation line as an indirect indicator of efficacy. Secondary outcomes investigated in this study were changes in pachymetry values, either central corneal thickness or corneal thickness at the thinnest point and endothelial cell density. We also investigated for the first time treatment-related adverse events and treatment failure, such as keratoconus progression, loss of ≥ lines2 of CDVA, delayed epithelial closure, persistent stromal haze, sterile infiltrates and infections.Of these 15 trials, after having analysed the methodology and trial quality, only four RCTs were included in the meta-analysis, of which two<a class="elsevierStyleCrossRefs" href="#bib0020">4,6</a> were of high quality with a low risk of bias, while the other two<a class="elsevierStyleCrossRefs" href="#bib0035">7,8</a> had an unclear risk of bias. Except for a significantly larger improvement in CDVA with the current epi-on CXL protocols (MD = 0.07, 95% CI 0.04−0.10, p < 0.001) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>), analysis of available well-designed unbiased comparative studies demonstrated that epi-on and epi-off CXL treatments have a comparable visual, topographical, pachymetric and endothelial parameter effect 1–2 years after surgery (p > 0.05) (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>). Sensitivity analysis showed that the result remained unchanged after elimination of studies with an uncertain risk of bias or performed with iontophoresis. As the epi-on CXL protocols preserve the epithelium, they involve a significant reduction in delayed epithelial healing (RD = 0.049, 95% CI 0.003−0.0946, p = 0.035) and persistent stromal haze formation (RD = 0.0525, 95% CI 0.0063−0.0986, p = 0.026).<elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia>In conclusion, said systematic literature review and meta-analysis documenting the comparative efficacy of epi-on vs. epi-off CXL treatments in halting keratoconus progression found that both protocols are equally effective. According to the studies included in the quantitative meta-analysis, the rate of keratoconus progression is not significantly different with the two protocols.The current evidence leaves the field open for final, confirmatory, well-designed and unbiased randomised clinical studies to confirm the similarities and differences in long-term efficacy and safety outcomes between epi-on and epi-off CXL techniques.FundingPartly financed by the Instituto de Salud Carlos III/State Research Agency and by the European Regional Development Fund (ERDF) “A way for Europe”. Thematic Network for Cooperative Health Research “OFTARED”. Reference: RD16/0008/0012.Conflict of interestNo conflict of interests was declared by the authors." 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