Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

Completed

• Conditions: HIV Infections; Acquired Immunodeficiency Syndrome
• Interventions: Device: Optical Coherence Tomography (OCT); Device: Frequency Doubling Technology (FDT) perimeter

• Registration Number: NCT00871078
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (FDT).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-28
• Last Update Posted: 2009-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Clinical diagnosis of AIDS
• Best-corrected visual acuity 20/25 or better
• Refractive error of 0±5.0 diopters and astigmatism of 0±3.0 diopters
• Normal intraocular pressure (≤21mmHg)

Exclusion Criteria

• Cataract or any visible media opacity
• HIV-related infectious retinopathy
• Risk factors for the development of glaucoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Optical Coherence Tomography (OCT)	HIV-positive patients with CD4 cell counts below 100 cells/mm³ at some point of time in their medical history lasting for at least 6 months
A	Frequency Doubling Technology (FDT) perimeter	HIV-positive patients with CD4 cell counts below 100 cells/mm³ at some point of time in their medical history lasting for at least 6 months
B	Optical Coherence Tomography (OCT)	HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records
B	Frequency Doubling Technology (FDT) perimeter	HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records
C	Optical Coherence Tomography (OCT)	HIV-negative patients (control group)
C	Frequency Doubling Technology (FDT) perimeter	HIV-negative patients (control group)

Trial Locations

Locations (1)

Federal University of São Paulo (UNIFESP/EPM); 🇧🇷 São Paulo, Brazil