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

NCT07350304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 141

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Optical Coherence Tomography

Subjects underwent bilateral Optical Coherence Tomography (OCT) imaging using both the Topcon Maestro2 and Zeiss Cirrus 5000 devices during the same clinical session. Manufacturer-recommended protocols were used: Wide Scan, RNFL Cube, and Macular Cube (Topcon), and Optic Disc Cube 200×200 and Macular Cube 512×128 (Zeiss). Imaging was performed back-to-back using factory-default settings and standardized pupil dilation to assess cross-platform agreement and repeatability of RNFL and GCIPL thickness measurements in glaucomatous eyes.

Sponsors & Collaborators

  • Topcon Medical Systems, Inc.

    collaborator INDUSTRY

  • Twin Cities Eye Consultants

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-02-14
Completion
2025-02-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07350304 on ClinicalTrials.gov