NCT02014688

Optical Coherence Tomography (OCT) Normative Data Collection Study

Multi-center Study for Normal Database of Optic Nerve Head, Retinal Nerve Fiber Layer, and Macula Parameters With the Heidelberg Spectralis OCT, Study 3

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: Heidelberg Engineering GmbH · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-12-18
• Last updated: 2015-08-20

Locations

1 site across 1 country: United States