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

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ClinicalTrials.gov Identifier: NCT00607100
Recruitment Status : Unknown
Verified November 2008 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : February 5, 2008
Last Update Posted : November 13, 2008
Sponsor:
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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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