Last updated on June 2018

Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)


Brief description of study

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 Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers.

Detailed Study Description

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 Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.

Clinical Study Identifier: NCT02785042

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Thomas Schulz, PhD

Assil Eye Institute
Santa Monica, CA United States
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Jason Bacharach, MD

North Bay Eye Associates
Santa Rosa, CA United States
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Gregory Panzo, MD

Mid Florida Eye Center Clinic
Mount Dora, FL United States
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Thomas Schulz, PhD

Illinois Eye Institute, Illinois College of Optometry
Chicago, IL United States
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Mitch Dul, OD

SUNY College of Optometry
New York, NY United States
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Gerard D'Aversa, MD

Ophthalmic Consultants of Long Island-Valley Stream
Valley Stream, NY United States
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Jay Katz, MD

Wills Eye Hospital
Philadelphia, PA United States
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Linda Zangwill, MD

University California San Diego
La Jolla, CA United States
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