Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

F

Federal University of São Paulo

Status

Completed

Conditions

HIV Infections
Acquired Immunodeficiency Syndrome

Treatments

Device: Optical Coherence Tomography (OCT)
Device: Frequency Doubling Technology (FDT) perimeter

Study type

Observational

Funder types

Other

Identifiers

NCT00871078
BRA-713/06

Details and patient eligibility

About

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).

Enrollment

90 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

A
Description:
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
Treatment:
Device: Frequency Doubling Technology (FDT) perimeter
Device: Optical Coherence Tomography (OCT)
B
Description:
HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records
Treatment:
Device: Frequency Doubling Technology (FDT) perimeter
Device: Optical Coherence Tomography (OCT)
C
Description:
HIV-negative patients (control group)
Treatment:
Device: Frequency Doubling Technology (FDT) perimeter
Device: Optical Coherence Tomography (OCT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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