Optical Coherence Tomography (OCT) Normative Data Collection Study (S-2013-3)

Multi-center Study for Normal Database of Optic Nerve Head, Retinal Nerve Fiber Layer, and Macula Parameters With the Heidelberg Spectralis OCT, Study 3

This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device.

Study Overview

• Status: Completed
• Conditions: Healthy

Detailed Description

This multi-center, prospective, observational (non-interventional) study is the third in a series to measure 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 normal volunteers of various non-Caucasian ethnic group, and data will be combined with Caucasian subjects to be representative of the US population: (1) Hispanic Descent, (2) Black or African American Descent, (3) Asian Descent, (4) American Indian or Alaskan Native Descent. This study will complement the previous study S-2012-1 NORM-cc, in which normal data from Caucasian individuals were collected.

The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 87 (enrollment target: 135) normal volunteers; each study site will recruit at least 29 (target: 45) subjects with an age range of 18 to 90 years and an approximately equal number of females and males. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit. All examinations performed on the subjects are non-significant risk procedures because the medical devices are cleared for marketing in Europe and in the U.S. Total study duration including IRB approval is anticipated to not exceed 4 months.

• Study Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003-4297
      • New York Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Recruitment will be from persons who respond to recruitment initiatives at the individual centers or have signed a release saying that they are willing to be approached for participation in research.

At least 87 subjects (enrollment target: 135 subjects) will be selected from qualifying normal volunteers. Age range will be from ≥18 to 90 years. The age of the subjects will be defined by their month of birth versus the month of giving consent to participate in this study. A subject who is 40 years and 11 months old will be counted as being in the age group "31 to 40 years". Each site will attempt to recruit subjects in about equal numbers in each age group. The distribution in the age groups should be fairly equal among subjects in each ethnic group alone.

Description

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 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 Descent, Black or African American Descent, Asian Descent, American Indian or Alaskan Native Descent
• 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, or not abnormal visual field by judgment of the ophthalmologist.
• 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.

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
American Indian or Alaskan Native Descent
Black or African American Descent
Asian Descent
Hispanic Descent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normative Data for optic nerve head, the peripapillary retinal nerve fiber layer, and the macula.	This normal database will be used to determine if an unknown subject has measurement values "within normal limits" or "outside normal limits." It is planned to classify an eye "within normal limits" if the measurement value is greater than or equal to the 5th percentile of the normal distribution (or less than or equal to the 95th percentile), and as "outside normal limits" if the measurement value is smaller than the 1st percentile (or larger than 99th percentile) of the normal distribution. Thus, the sample size must be large enough to ensure that the 1st and the 5th percentiles of the distribution are distinct.	12 months

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Jeffrey Liebman, MD, Manhattan Eye, Ear and Throat Hospital and New York University Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Normal subjects
• Other Study ID Numbers: S-2013-3 NORM-us