Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT

• Sponsor: University of Zurich (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01273285
• Collaborator: (none)
• Enrollment: 50
• Location: 1

Study Details

Study Description

Brief Summary

To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).

• Trial with medical device

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Patients and Healthy Controls	Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Mar 1, 2010

Outcome Measures

Primary Outcome Measures

1. reproducibility of retinal nerve fiber layer thickness measurement []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria: control group:

age 18yo or older, healthy

glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.

or severe optic media opacities.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Zurich		Switzerland

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01273285
• Other Study ID Numbers: RNFL-Repro
• First Posted: Jan 10, 2011
• Last Update Posted: Jan 10, 2011
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Jan 10, 2011