The goal of this observational study is to evaluate whether prostaglandin analogue eye drops have a direct neuroprotective effect on retinal ganglion cells - beyond their intraocular pressure (IOP)-lowering effect - in adult patients with glaucoma or ocular hypertension. The study includes individuals diagnosed with glaucoma (any sex/gender, adult age groups) undergoing standard clinical treatment. The main questions it aims to answer are:
* Do prostaglandin analogues provide a neuroprotective effect on retinal ganglion cells that is independent of their IOP-lowering properties? * Should prostaglandin analogues be promoted/favoured over other IOP-lowering compounds for long-term glaucoma management?
Researchers will compare an interventional group, which consist of 750 eyes treated with prostaglandin analogues (e.g., latanoprost, travoprost, tafluprost, bimatoprost, unoprostone), with a control group, which consist of 750 eyes treated with non-prostaglandin IOP-lowering compounds (e.g., timolol, dorzolamide, brimonidine, netarsudil) to see if treatment with prostaglandin analogues is associated with better retinal ganglion cell survival over a period of 3 years (36 months).
Data will be collected from individuals who had at least 36 months of documented follow-up, with clinical data available at approximately 3, 6, 12, 24, and 36 months. Eligible individuals must have been treated with either prostaglandin analogues or other intraocular pressure (IOP)-lowering agents as part of routine clinical care. The data to be obtained from medical records will include at least:
* Intraocular pressure readings * Visual field testing * OCT measures * Visual acuity * Adverse events * Treatment adherence/compliance * Additional glaucoma interventions
Age 18+ years
Established glaucoma diagnosis (primary open-angle glaucoma, normal tension Glaucoma, pseudoexfoliation glaucoma, pigmentary dispersion glaucoma) in either eye
Visual field mean deviation (MD; location-weighted mean difference from average age-corrected visual field sensitivity) of 2 visual fields differing by no more than 3 dB, for a mean deviation of better than -6.0 dB, or by no more than 4 dB, for a mean deviation worse than -6.0 dB, as measured using Humphrey perimetry (or equivalent Haag-Streit / Octopus; in at least one eye; analogous to The United Kingdom Glaucoma Treatment Study)
Treatment with either prostaglandin analogues only or another topically applied IOP-lowering compound only for at least 3 years
Follow-up period < 3 years
Number of patient visits <6 visits
Number of OCT, visual field readings during the observation period < 6
Low compliance/therapy interruption
1500 eyes (750 treated with prostaglandin analogues and 750 treated with a different IOP-lowering compound)
Cohort
Retrospective
Not listed
Intraocular pressure (IOP), measured using a Goldmann applanation tonometer, an iCare tonometer, or similar. Change in IOP value (mmHg).
Change in IOP value (mmHg).
Visual field (VF) - Mean Deviation, measured by automated perimetry testing devices, such as Haag-Streit Octopus, Zeiss Humphrey, or similar
Evaluation of Change in Mean Deviation (MD, dB).
Visual Field - Pattern Standard Deviation, measured by automated perimetry testing devices, such as Haag-Streit Octopus, Zeiss Humphrey, or similar.
Evaluation of Pattern Standard Deviation (PSD, dB).
Visual Field - Glaucoma Progression Analysis (GPA), measured by automated perimetry testing devices, such as Haag-Streit Octopus, Zeiss Humphrey, or similar.
Evaluation of Glaucoma Progression Analysis (GPA, %/year).
10 Visual Acuity, measured by Best Corrected Visual Acuity (BCVA) score, using Snellen and/or LogMar charts.
Changes in Best Corrected Visual Acuity (BCVA), Snellen and/or LogMar.
Adverse Events, as reported in patient's medical history.
Reported blurred vision, conjunctival hyperemia, dryness, itching, irritation, pain, light sensitivity, eye lash growth, changes in iris colour, orbital fat atrophy/periorbitopathy, intraocular inflammation, macular oedema, vitreous floaters.
Adherence to Study Treatment
Evaluation of number and percentage of participants adherence/compliance to study treatment (Yes or No).
Additional Glaucoma Interventions
Evaluation of number and percentage of occurrence of additional glaucoma-related procedures during the follow-up period \[Laser trabeculoplasty and/or cataract surgery\].
Retinal Cells apoptosis Detected by DARC Imaging
Detection of Apoptosing Retinal Cells Cell Count
Vascular Outcomes - Change in the FAZ area (OCT-A parameter), measured by Zeiss Cirrus AngioPlex, or similar.
Detection and quantification of Apoptosing Retinal Cells Cell Count (e.g., cells/mm²)
Vascular outcomes - Change in Peripapillary Vessel Density (OCT-A parameter), measured by Zeiss Cirrus AngioPlex, or similar.
Evaluation of Peripapillary Vessel Density (%).
Vascular outcomes - Change in Macular Vessel Density (OCT-A parameter), measured by Zeiss Cirrus AngioPlex, or similar
Evaluation of Macular Vessel Density (mm-1).
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Association for Innovation and Biomedical Research on Light and Image
Lead sponsor
European Vision Institute Clinical Research Network
Collaborator
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