Lazaridis, G;
Mohamed-Noriega, J;
Aguilar-Munoa, S;
Suzuki, K;
Nomoto, H;
Garway-Heath, DF;
United Kingdom Glaucoma Treatment Study Investigators, .;
(2021)
Imaging Outcomes in Clinical Trials of Treatments for Glaucoma.
Ophthalmology
, 128
(8)
pp. 1240-1242.
10.1016/j.ophtha.2020.11.027.
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Abstract
Currently, all therapies for glaucoma have been licensed based on their ability to lower intraocular pressure (IOP). However, the main outcome of interest to people with glaucoma is vision-related (VR) quality of life (QoL). Instruments measuring VR QoL are unlikely to be sensitive enough to function as the primary outcome for clinical trials, 1 but they remain important as secondary outcomes to capture side-effects of treatment. Although lowering IOP has been shown to slow visual field (VF) loss, 2 IOP is a far-removed surrogate for VR QoL in glaucoma. Furthermore, IOP obviously would be an inappropriate outcome for a trial of a neuroprotective treatment with no effect on IOP. In contrast, the association of VR QoL measures with VF loss and other measures of vision has been established. 3 Measurements of visual function are recognized by regulatory authorities as the appropriate primary outcome measure for clinical trials in glaucoma, 4 and the major clinical trials that have evaluated vision function as the primary outcome have used progressive VF loss as the main outcome measure.
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