Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

NCT00871078 | Completed

• 1 other identifier: BRA-713/06
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Study Arms (3)

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); Device: Frequency Doubling Technology (FDT) perimeter

B

HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records

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

C

HIV-negative patients (control group)

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

Interventions

Optical Coherence Tomography (OCT) DEVICE

Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls

A; B; C

Frequency Doubling Technology (FDT) perimeter DEVICE

24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.

A; B; C

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo (UNIFESP/EPM)

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Tiago Arantes, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 29, 2009

Record last verified: 2009-09

Locations

BR (1)