Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls

NCT01228721 | Terminated Phase 4

• 1 other identifier: RNFL-Eyetracker-Foll
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT. METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods.

• Trial with medical device

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• retinal nerve fiber layer thickness measurement

Interventions

Spectralis® SD-OCT, Heidelberg Engineering GmbH, H DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery).

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

Related Publications (1)

• Langenegger SJ, Funk J, Toteberg-Harms M. Reproducibility of retinal nerve fiber layer thickness measurements using the eye tracker and the retest function of Spectralis SD-OCT in glaucomatous and healthy control eyes. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3338-44. doi: 10.1167/iovs.10-6611.

  PMID: 21330656 DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: January 1, 2009
• Study Completion: December 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

CH (1)