High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve

• ClinicalTrials.gov Identifier: NCT00607100
• Recruitment Status: Unknown
• First Posted: February 5, 2008
• Last Update Posted: November 13, 2008
• Sponsor: University of Sao Paulo
• Information provided by: University of Sao Paulo

Tracking Information

• First Submitted Date: February 4, 2008
• First Posted Date: February 5, 2008
• Last Update Posted Date: November 13, 2008
• Study Start Date: December 2007
• Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve
• Official Title: High-Resolution Optical Coherence Tomography for Detection of Retinal Nerve Fiber Layer Loss in Band Atrophy of the Optic Nerve
• Brief Summary: The purpose of this study is to compare the abilities of high-speed,high-resolution (HR) optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with band atrophy from chismal compression and controls

Condition

• Band Atrophy
• Chiasmal Compression
• Neural Loss

• Intervention: Not Provided

Study Groups/Cohorts

• 1
  Patients with Band atrophy of the optic nerve
• 2
  Normal Controls

• Publications *: Costa-Cunha LV, Cunha LP, Malta RF, Monteiro ML. Comparison of Fourier-domain and time-domain optical coherence tomography in the detection of band atrophy of the optic nerve. Am J Ophthalmol. 2009 Jan;147(1):56-63.e2. doi: 10.1016/j.ajo.2008.07.020. Epub 2008 Sep 6.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 4, 2008): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2008
• Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Visual acuity better than 20/30
• Refractive error less 5 spherical diopter and 3 cylinder diopter
• Temporal field defect

Exclusion Criteria:

• Presence of glaucoma and optic nerve anomalies
• A normal nasal field

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT00607100
• Other Study ID Numbers: CAPPESQ N. 1056/07
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mario Luiz Ribeiro Monteiro, Phd, University of São Paulo
• Study Sponsor: University of Sao Paulo
• Collaborators: Not Provided

Investigators

• Principal Investigator: Luciana Costa Cunha, MD; University of São Paulo

• PRS Account: University of Sao Paulo
• Verification Date: November 2008