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.
This multi-center, prospective, observational (non-interventional) study is the third 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 volunteers of various non-Caucasian ethnic group, and data will be combined with Caucasian subjects to be representative of the US population: (1) Hispanic Descent, (2) Black or African American Descent, (3) Asian Descent, (4) American Indian or Alaskan Native Descent. This study will complement the previous study S-2012-1 NORM-cc, in which normal data from Caucasian individuals were collected. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 87 (enrollment target: 135) normal volunteers; each study site will recruit at least 29 (target: 45) 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. Total study duration including IRB approval is anticipated to not exceed 4 months.
Study Type
OBSERVATIONAL
Enrollment
166
New York Eye and Ear Infirmary
New York, New York, United States
Normative Data for optic nerve head, the peripapillary retinal nerve fiber layer, and 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 (or less than or equal to the 95th percentile), and as "outside normal limits" if the measurement value is smaller than the 1st percentile (or larger than 99th percentile) of the normal distribution. Thus, the sample size must be large enough to ensure that the 1st and the 5th percentiles of the distribution are distinct.
Time frame: 12 months
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