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

Healthy Clinical Trial

— S-2013-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089711
• Other study ID #: S-2013-2 NORM-jp
• Status: Completed
• Phase: N/A
• First received: March 15, 2014
• Last updated: August 19, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Heidelberg Engineering GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Japan	The University of Tokyo	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg Engineering GmbH

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No