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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
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Retina nerve fiber layer measurements
    Macular thickness measurements

    Secondary Outcome Measures

    Full Information

    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
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    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

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    Optical Coherence Tomography Measurements in Eyes With Band Atrophy

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