NCT02785042

Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-3)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 224 (actual)
• Sponsor: Heidelberg Engineering GmbH · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This prospective, single-arm clinical multicenter study intends to measure normal 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 Hispanic descent 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 240 normal volunteers.

Detailed description

This prospective, single-arm clinical multicenter study intends to measure normal 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 Hispanic descent 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 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	Heidelberg Spectralis OCT	OCT imaging

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2016-05-27
• Last updated: 2025-03-19

Locations

8 sites across 1 country: United States