Spectralis OCT Repeatability and Reproducibility Study — S-2013-1  

Glaucoma Clinical Trial

Official title: Repeatability and Reproducibility of Optic Nerve Head (ONH), Retinal Nerve Fiber Layer (RNFL), and Macula Parameters With the Heidelberg Spectralis OCT.

Status Completed

Clinical Trial Summary

This single-center, prospective, interventional clinical study is conducted to evaluate the repeatability and reproducibility of structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study are compared to those from a previous, larger healthy volunteer study that was conducted in the United States and Europe (S-2012-1), and data from glaucoma patients are compared to those from the healthy volunteers.

Clinical Trial Description

The study will include approximately 15 normal subjects and approximately 15 subjects who have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other study procedures 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 is anticipated to not exceed 4 weeks. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

• NCT number: NCT02209077
• Study type: Interventional
• Source: Heidelberg Engineering GmbH
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Completion date: July 2013