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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02785029
• Other study ID #: S-2015-1-aa
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2023

Study information

• Verified date: August 2023
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 African-American 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 234
• Est. completion date: July 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• OCT

Locations

Country	Name	City	State
United States	Illinois Eye Institute, Illinois College of Optometry	Chicago	Illinois
United States	St Albans Community Living, Center, Queens Campus	Jamaica	New York
United States	University California San Diego	La Jolla	California
United States	Mid Florida Eye Center Clinic	Mount Dora	Florida
United States	SUNY College of Optometry	New York	New York
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Assil Eye Institute	Santa Monica	California
United States	Ophthalmic Consultants of Long Island-Valley Stream	Valley Stream	New York

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bruch-Membrane-Opening - Minimum Rim Width (µm)	Bruch-Membrane-Opening - Minimum Rim Width (µm)	Baseline
Primary	Bruch-Membrane-Opening - Minimum Rim Area (µm^2)	Bruch-Membrane-Opening - Minimum Rim Area (µm^2)	Baseline
Primary	Peripapillary Retinal Nerve Fibre Layer Thickness (µm)	Peripapillary Retinal Nerve Fibre Layer Thickness (µm)	Baseline