NCT00395122

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
Last Updated

November 2, 2006

Status Verified

November 1, 2006

First QC Date

November 1, 2006

Last Update Submit

November 1, 2006

Conditions

Vision Disorders

Keywords

Band AtrophyOptical Coherence TomographyScanning Laser PolarimetryChiasmal Lesions

Outcome Measures

Primary Outcomes (2)

  • Retina nerve fiber layer measurements

  • Macular thickness measurements

Interventions

Retinal nerve fiber layer and macular thickness measurementsDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence of glaucoma and optic nerve anomalies
  • Anormal nasal field

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21225123DERIVED

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mário LR Monteiro, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

April 1, 2005

Study Completion

October 1, 2006

Last Updated

November 2, 2006

Record last verified: 2006-11