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:
Inclusion Criteria:
* 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
* Documented follow-up period of at least 3 years
* At least 6 patient visits documented over the follow-up period with readings of IOP, visual field, OCT
* No additional glaucoma intervention apart from laser trabeculoplasty and/or cataract surgery during the observational period
Exclusion Criteria:
* 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
* Beginning of combination therapy of prostaglandin analogues and other IOP lowering eye drops during the observation period
* In case of glaucoma diagnosis in both eyes: different topical IOP-lowering treatment regimes (e.g. prostaglandin analogues in one eye and beta-adrenergic blocking agents in the fellow eye)
* Additional glaucoma intervention during the observational period other than laser trabeculoplasty and/or cataract surgery
Primary outcome measure(s)
Intraocular pressure (IOP), measured using a Goldmann applanation tonometer, an iCare tonometer, or similar. Change in IOP value (mmHg). — 6 months 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 — 6 months 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. — 6 months 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. — 6 months Evaluation of Glaucoma Progression Analysis (GPA, %/year).
Optical Coherence Tomography - Change in Average GCL+IPL Thickness, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar. — 6 months Evaluation of Change in Average GCL+IPL thickness (µm).
Optical Coherence Tomography - Average RNFL Thickness, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar. — 6 months Evaluation of average RNFL thickness (µm).
Optical Coherence Tomography - Disc Rim Area, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar. — 6 months Evaluation of Disc Rim Area (mm²).
Optical Coherence Tomography - Cup-to-disc Ratio, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar. — 6 months Evaluation of Cup-to-disc ratio (average and vertical).
Optical Coherence Tomography - Central Subfield Thickness, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar. — 6 months Evaluation of Central Subfield Thickness (µm).
Trial sites (10)
Facility
City
Region
Status
Department of Ophthalmology University of Bonn
Bonn
Germany
University Eye Hospital Leipzig
Leipzig
Germany
Centre for Clinical Trials at San Paolo Hospital University of Milan
Milan
Italy
Eye Unit, University Hospital Maggiore della Carità
Novara
Italy
Centro de Oftalmologia Barraquer
Barcelona
Spain
Retina Unit, Department of Ophthalmology, Bellvitge University Hospital
Barcelona
Spain
University Hospital Basel
Basel
Switzerland
Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital
Liverpool
United Kingdom
ICORG - Imperial College Ophthalmologic Research Group
London
United Kingdom
NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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