Comparison of Two OCT Device RNFL and GCIPL Measurements in Mild, Moderate, and Severe Glaucoma

Completed

Conditions studied: Glaucoma

In brief

This research study was designed to evaluate how consistently two different imaging devices measure the thickness of retinal layers in patients with glaucoma. The two machines, the Topcon Maestro2 and the Zeiss Cirrus 5000, are commonly used in eye clinics to take high-resolution scans of the retina and optic nerve. These scans help doctors monitor glaucoma and detect disease progression. The goal of this study was to compare the results from both machines when scanning the same patients, and to determine how closely their measurements align. Researchers also developed mathematical models that allow doctors to convert results from one machine to the other, which could help ensure consistency when a patient receives scans on different devices over time or at different clinics. A total of 141 eyes from patients with varying levels of glaucoma severity were included in the study. Scans were performed using standard imaging protocols on both machines. Researchers analyzed the average thickness of two important retinal layers: the retinal nerve fiber layer (RNFL) and the ganglion cell-inner plexiform layer (GCIPL). This study helps improve our understanding of how different imaging devices compare and provides tools for standardizing results across platforms. The findings may help eye care providers make more confident decisions when reviewing images from different machines, improving the care and monitoring of patients with glaucoma. This was an investigator-initiated study sponsored by Twin Cities Eye Consultants with funding support from Topcon Healthcare. No new medications, treatments, or procedures were tested as part of this research. The study only involved non-invasive eye imaging scans that are already widely used in clinical practice.

Key facts

Study ID: NCT07350304
Run by: Twin Cities Eye Consultants
People needed: 141
Starts: 2024-10-28
Expected to finish: 2025-02-14
Last updated by the study team: 2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female patients at least 18 years of age
A diagnosis of mild, moderate or severe glaucoma.
Optic nerve appearance characteristic of glaucoma.
< +/- 6D Spherical equivalent Refractive Error
BCVA ≥ 20/40
Previous Zeiss OCT RNFL with signal strength of ≥ 7/10
The subject is able to understand the requirements of the study and provide written informed consent.
Subject is willing to follow study instructions, agrees to comply with all study procedures and testing.

You may not qualify if…

If pseudophakic, PCO must be ≤ trace
If phakic, the cataract must be ≤ 1+
No diagnosis of optic nerve disease other than glaucoma, and no macular disease.
Current participation or participation in any drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days.

Where it is running

Twin Cities Eye Consultants — Coon Rapids, Minnesota, United States

Full record on ClinicalTrials.gov

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