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Optical Coherence Tomography Measurements in Eyes With Band Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00395122
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : November 2, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Vision Disorders Device: Retinal nerve fiber layer and macular thickness measurements

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2005
Estimated Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Retina nerve fiber layer measurements
  2. Macular thickness measurements

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395122


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00395122     History of Changes
Other Study ID Numbers: OCT in band atrophy
FAPESP grant No 05/55326-1
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: November 2, 2006
Last Verified: November 2006

Keywords provided by University of Sao Paulo:
Band Atrophy
Optical Coherence Tomography
Scanning Laser Polarimetry
Chiasmal Lesions

Additional relevant MeSH terms:
Atrophy
Vision Disorders
Pathological Conditions, Anatomical
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms