Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)

NCT02785029 | Terminated

• 1 other identifier: S-2015-1-aa
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 8

Brief Summary

This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (3)

• Bruch-Membrane-Opening - Minimum Rim Width (µm)

  Bruch-Membrane-Opening - Minimum Rim Width (µm)

  Baseline

• Bruch-Membrane-Opening - Minimum Rim Area (µm^2)

  Bruch-Membrane-Opening - Minimum Rim Area (µm\^2)

  Baseline

• Peripapillary Retinal Nerve Fibre Layer Thickness (µm)

  Peripapillary Retinal Nerve Fibre Layer Thickness (µm)

  Baseline

Study Arms (1)

Normal healthy Volunteers

OCT imaging

Device: OCT

Interventions

OCT DEVICE

Normal healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy eyes without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve from subjects of Black or African-American decent (self-reported)

You may qualify if:

• Able and willing to undergo the test procedures, give consent, and to follow instructions.
• Signed informed consent
• Age ≥18 to 90.
• Healthy eye without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve. Small drusen are acceptable in older subjects.
• Black or African-American decent (self-reported)
• Negative history of glaucoma (not including family history)
• Intraocular pressure ≤21mmHg.
• Best corrected visual acuity ≥20/40.
• Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
• Axial length ≤ 26.0 mm (by optical biometry)
• Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits or not abnormal visual field by judgment of the ophthalmologist / optometrist
• Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
• If both eyes are eligible, both eyes enter the study.

You may not qualify if:

• Vulnerable subjects (as defined in ISO 14155 GCP) with the exception of employees of the site, and, if applicable, students of the respective university. Staff that is listed on the delegation form are excluded from participation.
• Subjects unable to read or write
• Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
• Unusable disc stereo photos.
• Inability to undergo the tests.
• Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance).
• Minimum requirements are:
• Retina completely included in image frame,
• Quality Score ≥ 20 in the stored ART mean images, and
• For ONH-R scan: Center position error ≤ 100 μm.

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (8)

University California San Diego

La Jolla, California, 92093, United States

Location

Assil Eye Institute

Santa Monica, California, 90404, United States

Location

Mid Florida Eye Center Clinic

Mt. Dora, Florida, 32757, United States

Location

Illinois Eye Institute, Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

St Albans Community Living, Center, Queens Campus

Jamaica, New York, 11425, United States

Location

SUNY College of Optometry

New York, New York, 10036, United States

Location

Ophthalmic Consultants of Long Island-Valley Stream

Valley Stream, New York, 11581, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Balwantray Chauhan, OD

  Department of Ophthalmology and Visual Sciences Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 19, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)