- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02089711
Optical Coherence Tomography (OCT) Normative Data Collection Study (S-2013-2) (S-2013-2)
August 19, 2015 updated by: Heidelberg Engineering GmbH
Multi-center Study for Normal Database of Optic Nerve Head, Retinal Nerve Fiber Layer, and Macula Parameters With the Heidelberg Spectralis OCT, Study 2
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
392
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 158-8531
- The University of Tokyo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
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.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Japanese healthy subjects
subjects with healthy eyes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normative data for ONH dimensions, RNFL thickness, retinal thickness and thickness of retinal layers at the macula.
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Makoto Araie, MD, PhD, Tokyo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
March 15, 2014
First Submitted That Met QC Criteria
March 15, 2014
First Posted (Estimate)
March 18, 2014
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
Other Study ID Numbers
- S-2013-2 NORM-jp
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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