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

NCT07350304 | Completed FDA Device

• 1 other identifier: TCEC-001
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Glaucoma

Keywords

Glaucoma; OCT; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Agreement Between Topcon Maestro2 and Zeiss Cirrus 5000 OCT Devices

  This primary outcome evaluates the cross-platform agreement of retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL) thickness measurements between the Topcon Maestro2 and Zeiss Cirrus 5000 devices in glaucoma and glaucoma-suspect eyes. The analysis will assess absolute differences, standard deviation, 95% limits of agreement, and proportion of eyes within a ±3 micron threshold for global and sectoral measurements.

  Day of single study visit

Secondary Outcomes (4)

• Repeatability of Topcon Maestro2 OCT Measurements

  Day of single study visit

• Impact of Glaucoma Severity on Device Agreement

  Day of single study visit

• Cross-Device Agreement by Quadrant and Sectoral Analysis

  Day of single study visit

• Predictive Modeling to Convert Measurements Between Devices

  Day of single study visit

Study Arms (2)

Derivation

The derivation cohort consisted of the first 72 eyes enrolled in the study. These participants had established glaucoma and were selected consecutively from a single clinical practice. Each eye underwent back-to-back OCT imaging using both the Topcon Maestro2 and Zeiss Cirrus 5000 devices during the same visit. Data from this cohort were used to develop statistical conversion models assessing agreement and potential equivalence in RNFL and GCIPL thickness measurements across platforms. Non-interventional imaging procedures were performed using standard manufacturer-recommended scan protocols. These included the Topcon Wide Scan, RNFL Cube, and Macular Cube protocols, as well as the Zeiss Optic Disc Cube 200×200 and Macular Cube 512×128 protocols. All scans were conducted by a single trained technician under controlled clinical conditions.

Diagnostic Test: Optical Coherence Tomography

Validation

The validation cohort included the subsequent 69 eyes enrolled in the study, following the derivation cohort. Imaging procedures and clinical characteristics mirrored those of the derivation group. This cohort was used to test and validate the accuracy and reliability of the conversion models derived from the initial group. Subjects underwent the same non-invasive imaging protocols on both the Topcon Maestro2 and Zeiss Cirrus 5000 devices during a single clinic session. Scan protocols, technician, and environmental conditions were consistent with those of the derivation cohort to preserve standardization.

Diagnostic Test: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DIAGNOSTIC_TEST

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.

Also known as: OCT, Maestro2, Cirrus 5000

Derivation; Validation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult patients aged 18 years or older with established or suspected glaucoma. Subjects were consecutively enrolled from a single tertiary ophthalmology practice in Minnesota. The final cohort included a range of glaucoma severity (mild, moderate, and severe) and was predominantly composed of White (59.6%) and female (59.6%) individuals. All participants underwent same-day, back-to-back OCT imaging on both the Topcon Maestro2 and Zeiss Cirrus 5000 systems.

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.

Sponsors & Collaborators

• Twin Cities Eye Consultants: lead
• Topcon Medical Systems, Inc.: collaborator

Study Sites (1)

Twin Cities Eye Consultants

Coon Rapids, Minnesota, 55433, United States

Location

Related Publications (5)

• Tan O, Chopra V, Lu AT, Schuman JS, Ishikawa H, Wollstein G, Varma R, Huang D. Detection of macular ganglion cell loss in glaucoma by Fourier-domain optical coherence tomography. Ophthalmology. 2009 Dec;116(12):2305-14.e1-2. doi: 10.1016/j.ophtha.2009.05.025. Epub 2009 Sep 10.

  PMID: 19744726 BACKGROUND

• Wong E, Yoshioka N, Kalloniatis M, Zangerl B. Cirrus HD-OCT short-term repeatability of clinical retinal nerve fiber layer measurements. Optom Vis Sci. 2015 Jan;92(1):83-8. doi: 10.1097/OPX.0000000000000452.

  PMID: 25479451 BACKGROUND

• Kotowski J, Wollstein G, Folio LS, Ishikawa H, Schuman JS. Clinical use of OCT in assessing glaucoma progression. Ophthalmic Surg Lasers Imaging. 2011 Jul;42 Suppl(0):S6-S14. doi: 10.3928/15428877-20110627-01.

  PMID: 21790113 BACKGROUND

• Vazirani J, Kaushik S, Pandav SS, Gupta P. Reproducibility of retinal nerve fiber layer measurements across the glaucoma spectrum using optical coherence tomography. Indian J Ophthalmol. 2015 Apr;63(4):300-5. doi: 10.4103/0301-4738.158064.

  PMID: 26044467 BACKGROUND

• Mwanza JC, Oakley JD, Budenz DL, Anderson DR; Cirrus Optical Coherence Tomography Normative Database Study Group. Ability of cirrus HD-OCT optic nerve head parameters to discriminate normal from glaucomatous eyes. Ophthalmology. 2011 Feb;118(2):241-8.e1. doi: 10.1016/j.ophtha.2010.06.036. Epub 2010 Oct 28.

  PMID: 20920824 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: October 28, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)