Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

Condition(s) studied

Study summary

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

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)

More Association for Innovation and Biomedical Research on Light and Image trials in Italy

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