Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Optical Coherence Tomography Measurements in Eyes With Band Atrophy

This study has been completed.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo Identifier:
First received: November 1, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

The study is designed to evaluate the ability of optical coherence tomography and VCC scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these new technologies are able to identify such pattern. The idea is that by using eyes with band atrophy one is able to investigate the ability of the new technologies in measuring the retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.

Condition Intervention
Vision Disorders
Device: Retinal nerve fiber layer and macular thickness measurements

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Ability of Optical Coherence Tomography With a Normative Database to Detect Band Atrophy of the Optic Nerve

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Retina nerve fiber layer measurements
  • Macular thickness measurements

Estimated Enrollment: 30
Study Start Date: April 2005
Estimated Study Completion Date: October 2006

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:Patients with long standing chiasmal lesions and temporal visual field defect with the following criteria:

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

Exclusion Criteria:

  1. Presence of glaucoma and optic nerve anomalies
  2. Anormal nasal field
  Contacts and Locations
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Please refer to this study by its identifier: NCT00395122

Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Mário LR Monteiro, MD, PhD University of Sao Paulo
  More Information

No publications provided Identifier: NCT00395122     History of Changes
Other Study ID Numbers: OCT in band atrophy, FAPESP grant No 05/55326-1
Study First Received: November 1, 2006
Last Updated: November 1, 2006
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Band Atrophy
Optical Coherence Tomography
Scanning Laser Polarimetry
Chiasmal Lesions processed this record on March 03, 2015