Optical Coherence Tomography (OCT) Data Collection Study

NCT ID: NCT01641835

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-12-31

Brief Summary

Collect OCT data to evaluate the range and age trend of ocular measurements.

Detailed Description

This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.

Conditions

Glaucoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Normals

No eye disease.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subject is not an employee of the eye clinic.
• Age ≥18 to 90.
• Able and willing to undergo the test procedures, give consent, and to follow instructions.
• Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
• Caucasian decent (self-reported).
• Negative history of glaucoma.
• Intraocular pressure ≤21mmHg.
• Best corrected visual acuity ≥0.5.
• Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
• Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
• 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.
• When both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures.

Exclusion Criteria

• 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.
• Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg Engineering GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Balwantray Chauhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University, Halifax, NS, Canada

Claude Burgoyne, MD

Role: PRINCIPAL_INVESTIGATOR

Devers Eye Institute, Portland, OR, USA

Christopher Girkin, MD

Role: PRINCIPAL_INVESTIGATOR

Callahan Eye Foundation Hospital, Birmingham, AL, USA

Christian Mardin, MD

Role: PRINCIPAL_INVESTIGATOR

Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany

Alexander Scheuerle, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsaugenklinik, Heidelberg, Germany

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

S-2012-1 NORM-cc

Identifier Type: -

Identifier Source: org_study_id