Clinical trial NCT02089711: Optical Coherence Tomography (OCT) Normative Data Collection Study (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Normal subjects
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Normative data for ONH dimensions, RNFL thickness, retinal thickness and thickness of retinal layers at the macula.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: The University of Tokyo
Study officials:
affiliation: Tokyo University
name: Makoto Araie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: