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

• ClinicalTrials.gov Identifier: NCT02089711
• Recruitment Status: Completed
• First Posted: March 18, 2014
• Last Update Posted: August 20, 2015
• Sponsor: Heidelberg Engineering GmbH
• Information provided by (Responsible Party): Heidelberg Engineering GmbH

Study Description

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.

Condition or disease
Healthy

Detailed Description:

This multi-center, prospective, observational (non-interventional) study is the second 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 Japanese 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 224 (enrollment target: 249) normal volunteers; each study site will recruit 32 to 40 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 392 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multi-center Study for Normal Database of Optic Nerve Head, Retinal Nerve Fiber Layer, and Macula Parameters With the Heidelberg Spectralis OCT, Study 2
• Study Start Date: January 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Groups and Cohorts

Group/Cohort
Japanese healthy subjects; subjects with healthy eyes

Outcome Measures

Primary Outcome Measures :

1. Normative data for ONH dimensions, RNFL thickness, retinal thickness and thickness of retinal layers at the macula. [ Time Frame: 12 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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 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.

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.

Contacts and Locations

Locations

Japan

The University of Tokyo

Tokyo, Japan, 158-8531

Sponsors and Collaborators

Heidelberg Engineering GmbH

Investigators

• Principal Investigator: Makoto Araie, MD, PhD; Tokyo University

More Information

• Responsible Party: Heidelberg Engineering GmbH
• ClinicalTrials.gov Identifier: NCT02089711
• Other Study ID Numbers: S-2013-2 NORM-jp
• First Posted: March 18, 2014
• Last Update Posted: August 20, 2015
• Last Verified: August 2015

Keywords provided by Heidelberg Engineering GmbH:

Normal subjects