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
  Purpose

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).


Condition Intervention
HIV Infections
Acquired Immunodeficiency Syndrome
Device: Optical Coherence Tomography (OCT)
Device: Frequency Doubling Technology (FDT) perimeter

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients Using Optical Coherence Tomography and Frequency Doubling Technology Perimetry

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Estimated Enrollment: 90
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV infected patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871078

Locations
Brazil
Federal University of São Paulo (UNIFESP/EPM)
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Tiago Arantes, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Tiago Eugênio Faria e Arantes, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00871078     History of Changes
Other Study ID Numbers: BRA-713/06
Study First Received: March 27, 2009
Last Updated: September 28, 2009
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014