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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese healthy subjects | subjects with healthy eyes |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Minimum requirements are:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Makoto Araie, MD, PhD | Tokyo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tokyo | Tokyo | Tokyo | 158-8531 | Japan |
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