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Imaging Outcomes in Clinical Trials of Treatments for Glaucoma

Lazaridis, G; Mohamed-Noriega, J; Aguilar-Munoa, S; Suzuki, K; Nomoto, H; Garway-Heath, DF; United Kingdom Glaucoma Treatment Study Investigators, .; (2020) Imaging Outcomes in Clinical Trials of Treatments for Glaucoma. Ophthalmology 10.1016/j.ophtha.2020.11.027. (In press).

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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.

Type: Article
Title: Imaging Outcomes in Clinical Trials of Treatments for Glaucoma
Location: United States
DOI: 10.1016/j.ophtha.2020.11.027
Publisher version: https://dx.doi.org/10.1016/j.ophtha.2020.11.027
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Clinical trial, Glaucoma, Latanoprost, OCT, Optical coherence tomography, Visual fields, Visual function
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Electronic and Electrical Eng
URI: https://discovery.ucl.ac.uk/id/eprint/10124440
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