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

Sponsors and collaborators

Association for Innovation and Biomedical Research on Light and Image

Lead sponsor

European Vision Institute Clinical Research Network

Collaborator