Topcon 3D OCT-1000 Optical Coherence Tomography System

NCT00792259 | Completed Results

• 1 other identifier: Topcon 01
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.

Conditions

Retinal Disease; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device

  The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer

  30 Minutes

Study Arms (3)

1

Patients with Retinal Disease

2

Patients without Retinal Disease

3

Normal Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ophthalmology practice

You may qualify if:

• Male or female
• Between 18 and 80 years of age
• Either eye, but only one eye per subject will be enrolled
• Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

You may not qualify if:

• Any known ocular disease
• Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
• Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.
• Retinal Disease
• Male or female
• Between 18 and 80 years of age
• Either eye, but only one eye per subject will be enrolled
• Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
• A range of retinal thickness will be included
• Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
• Presence of glaucoma
• Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.

Sponsors & Collaborators

• Topcon Medical Systems, Inc.: lead

Study Sites (4)

Retina Consultations

Bronxville, New York, 10708, United States

Location

New York Eye and Ear-Glaucoma Associates of New York

New York, New York, 10003, United States

Location

Vitreous-Retina-Macula Consultants of NY

New York, New York, 10022, United States

Location

SUNY

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Retinal Diseases; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Ocular Hypertension

Results Point of Contact

• Title: Bob Gibson
• Organization: Topcon Medical Systems

RGIBSON@TOPCON.COM

(201) 599-5121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 28, 2022
• Results First Posted: June 17, 2015

Record last verified: 2022-06

Locations

US (4)