Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00871078
First received: March 27, 2009
Last updated: September 28, 2009
Last verified: September 2009

March 27, 2009
September 28, 2009
June 2008
September 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00871078 on ClinicalTrials.gov Archive Site
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Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients
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).

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

HIV infected patients

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • 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.
  • 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
    Interventions:
    • Device: Optical Coherence Tomography (OCT)
    • Device: Frequency Doubling Technology (FDT) perimeter
  • B
    HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records
    Interventions:
    • Device: Optical Coherence Tomography (OCT)
    • Device: Frequency Doubling Technology (FDT) perimeter
  • C
    HIV-negative patients (control group)
    Interventions:
    • Device: Optical Coherence Tomography (OCT)
    • Device: Frequency Doubling Technology (FDT) perimeter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00871078
BRA-713/06
No
Tiago Eugênio Faria e Arantes, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Tiago Arantes, MD Federal University of São Paulo
Federal University of São Paulo
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP