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

Stopped early

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT02785042

Run by

Heidelberg Engineering GmbH

People needed

224

Starts

2016-06-01

Expected to finish

2023-07-01

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

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.
• Hispanic 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).

Where it is running

• University California San Diego — La Jolla, California, United States
• Assil Eye Institute — Santa Monica, California, United States
• North Bay Eye Associates — Santa Rosa, California, United States
• Mid Florida Eye Center Clinic — Mt. Dora, Florida, United States
• Illinois Eye Institute, Illinois College of Optometry — Chicago, Illinois, United States
• SUNY College of Optometry — New York, New York, United States
• Ophthalmic Consultants of Long Island-Valley Stream — Valley Stream, New York, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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