Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

ConditionGlaucoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociation for Innovation and Biomedical Research on Light and Image

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,500 Participants
are grouped into 2 trial groups

Locations

10
Germany
Department of Ophthalmology University of Bonn Bonn Germany
University Eye Hospital Leipzig Leipzig Germany
Italy
Centre for Clinical Trials at San Paolo Hospital University of Milan Milan Italy
Eye Unit, University Hospital Maggiore della Carità Novara Italy

Sponsors and collaborators

Association for Innovation and Biomedical Research on Light and Image

Lead sponsor

European Vision Institute Clinical Research Network

Collaborator