Aim: To classify the comparative quantity and quality of the RCT evidence of pharmacological treatment for glaucoma.
Method: A systematic review of MEDLINE, EMBASE Cochrane CENTRAL and relevant conference proceedings was conducted up to March 2007. RCTs recruiting adults with primary open angle glaucoma (POAG) and/or ocular hypertension (OH) receiving any topical medication or placebo were included. RCTs containing a prostaglandin treatment arm were specifically considered.
Results: A total of 510 publications were identified. Of these, 181 studies had a prostaglandin treatment arm. The median study duration was 12 weeks (IQR 4-13) and 78% of included trials had a duration of 3 months or less. The four studies over 1 year in duration all included a latanoprost and timolol treatment arm. There was a lack of data on younger populations (median of the mean ages of included patients was 63.4 years [IQR: 61-66 years]). Caucasians constituted 79.6% of the studied population. Evidence by ethnicity as well as by co-morbidity, was scarce. The primary outcome for 92% of studies was IOP reduction; little was reported on other indicators. Most trials reported adverse events, with hyperaemia most commonly reported.
Conclusion: The RCT evidence base for glaucoma treatment is extensive. This systematic review is the first to consider the characteristics of all RCTs containing a prostaglandin arm. The majority of trials are of short duration and focus on IOP as the efficacy outcome. The limitations of this study are that only trials with a prostaglandin treatment arm are included and due to the large number of included trials only top line data were extracted.