Optical Coherence Tomography Measurements in Eyes With Band Atrophy
Primary Purpose
Vision Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Retinal nerve fiber layer and macular thickness measurements
Sponsored by
About this trial
This is an interventional diagnostic trial for Vision Disorders focused on measuring Band Atrophy, Optical Coherence Tomography, Scanning Laser Polarimetry, Chiasmal Lesions
Eligibility Criteria
Inclusion Criteria:Patients with long standing chiasmal lesions and temporal visual field defect with the following 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
- Anormal nasal field
Sites / Locations
Outcomes
Primary Outcome Measures
Retina nerve fiber layer measurements
Macular thickness measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT00395122
First Posted
November 1, 2006
Last Updated
November 1, 2006
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00395122
Brief Title
Optical Coherence Tomography Measurements in Eyes With Band Atrophy
Official Title
Evaluation of the Diagnostic Ability of Optical Coherence Tomography With a Normative Database to Detect Band Atrophy of the Optic Nerve
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders
Keywords
Band Atrophy, Optical Coherence Tomography, Scanning Laser Polarimetry, Chiasmal Lesions
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Retinal nerve fiber layer and macular thickness measurements
Primary Outcome Measure Information:
Title
Retina nerve fiber layer measurements
Title
Macular thickness measurements
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Patients with long standing chiasmal lesions and temporal visual field defect with the following 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
Anormal nasal field
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mário LR Monteiro, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21225123
Citation
Moura FC, Costa-Cunha LV, Malta RF, Monteiro ML. Relationship between visual field sensitivity loss and quadrantic macular thickness measured with Stratus-Optical coherence tomography in patients with chiasmal syndrome. Arq Bras Oftalmol. 2010 Sep-Oct;73(5):409-13. doi: 10.1590/s0004-27492010000500004.
Results Reference
derived
Learn more about this trial
Optical Coherence Tomography Measurements in Eyes With Band Atrophy
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