Optical Coherence Tomography (OCT) Data Collection Study

Completed

• Conditions: Glaucoma

• Registration Number: NCT01641835
• Lead Sponsor: Heidelberg Engineering GmbH

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-08-01
• Status Verified: 2016-09
• Results First Submitted QC: 2016-10-26
• Last Update Submitted: 2016-10-26
• Results First Posted: 2016-12-19
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoints	3 months	The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.
Bruch's Membrane Opening - Minimum Rim Area, Global	3 months

Trial Locations

Locations (1)

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada