Effect on ocular blood flow of Combigan® versus placebo in patients with ocular hypertension

Abstract

Purpose

This study was undertaken to compare the ocular haemodynamic effects of Combigan^® versus placebo in patients with ocular hypertension (OHT).

Methods

Thirty patients with OHT were included in a controlled, randomised, double blind study in two parallel groups; 15 were randomised to receive Combigan^® and 15 to receive placebo for a period of 3 months. At baseline and at 3 months retrobulbar blood flowmeasurements of the ophthalmic artery (OA) and central retinal artery (CRA) were taken using colour Doppler imaging(CDI) ultrasound, concurrently with intraocular pressure (IOP).

Results

Combigan^® significantly reduced IOP after 3 months of treatment (P = 0.001), whereas placebo showed no significant change in IOP. The baseline haemodynamic parameters were similar between treatment and placebo groups. Patients treated with Combigan^® showed a statistically significant decrease in CRA resistive index (P = 0.007).

Conclusions

Patients treated for 3 months with Combigan^® showed a significant decrease of CRA resistive index that could be explained by the decrease in IOP

Resumen

Propósito

Estudiar los cambios hemodinámicos retrobulbares mediante ecografía doppler color, en pacientes hipertensos oculares (HTO) en tratamiento con Combigan^® versus placebo.

Método

Treinta pacientes randomizados en 2 grupos paralelos fueron incluidos en un estudio prospectivo y a doble ciego; quince de ellos en tratamiento con Combigan^® y quince en tratamiento con placebo, durante un periodo de 3 meses. Se obtuvieron medidas de la presión intraocular (PIO) y del flujo sanguíneo a nivel de la arteria central de la retina (ACR) y la arteria oftámica en el momento basal y a los 3 meses.

Resultados

Combigan^® redujo significativamente la PIO tras tres meses de tratamiento (p = 0,001). Los parámetros hemodinámicos basales fueron similares entre los grupos placebo y tratamiento. Los pacientes tratados con Combigan^® mostraron un descenso estadísticamente significativo del índice de resistencia de la ACR (p = 0,007).

Conclusiones

Los pacientes tratados durante 3. meses con Combigan^® mostraron un descenso estadísticamente significativo del índice de resistenciade la ACR que podría explicarse por el descenso de PIO.