Optical Coherence Tomography Measurements in Eyes With Band Atrophy

Vision Disorders Clinical Trial

Official title:

Evaluation of the Diagnostic Ability of Optical Coherence Tomography With a Normative Database to Detect Band Atrophy of the Optic Nerve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395122
• Other study ID #: OCT in band atrophy
• Secondary ID: FAPESP grant No
• Status: Completed
• Phase: N/A
• First received: November 1, 2006
• Last updated: November 1, 2006
• Start date: April 2005
• Est. completion date: October 2006

Study information

• Verified date: November 2006
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Vision Disorders

Intervention

Device:
• Retinal nerve fiber layer and macular thickness measurements

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retina nerve fiber layer measurements
Primary	Macular thickness measurements