Optical Coherence Tomography (OCT) Normative Data Collection Study (S-2013-2)

NCT02089711 | Completed DMC

• 1 other identifier: S-2013-2 NORM-jp
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

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. The range will be determined for each structural parameter across normal eyes in Japanese subjects, and the measurements stratified according to age.

Conditions

Healthy

Keywords

Normal subjects

Outcome Measures

Primary Outcomes (1)

• Normative data for ONH dimensions, RNFL thickness, retinal thickness and thickness of retinal layers at 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, and as "outside normal limits" if the measurement value is smaller than the 1st percentile (or larger than 99th percentile) of the normal distribution.

  12 months

Study Arms (1)

Japanese healthy subjects

subjects with healthy eyes

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

At least 224 Japanese subjects (enrollment target: 249 subjects) will be selected from qualifying normal volunteers. Age ranges will be from ≥18 to 90 years. 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.

You may qualify if:

• 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.
• Japanese 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.
• Axial length ≤ 26.0 mm
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

The University of Tokyo

Tokyo, Tokyo, 158-8531, Japan

Location

Study Officials

• Makoto Araie, MD, PhD

  Tokyo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2014
• First Posted: March 18, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

JP (1)