Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

September 28, 2009 updated by: Federal University of São Paulo

Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients Using Optical Coherence Tomography and Frequency Doubling Technology Perimetry

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Federal University of São Paulo (UNIFESP/EPM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV infected patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
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
Device: Optical Coherence Tomography (OCT)
Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls
Device: Frequency Doubling Technology (FDT) perimeter
24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.
B
HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records
Device: Optical Coherence Tomography (OCT)
Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls
Device: Frequency Doubling Technology (FDT) perimeter
24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.
C
HIV-negative patients (control group)
Device: Optical Coherence Tomography (OCT)
Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls
Device: Frequency Doubling Technology (FDT) perimeter
24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Tiago Arantes, MD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2009

Last Update Submitted That Met QC Criteria

September 28, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRA-713/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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