Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients
NCT ID: NCT00871078
Last Updated: 2009-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2008-06-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
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
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
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
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)
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
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.
Interventions
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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
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 Criteria
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Inclusion Criteria
* 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
* HIV-related infectious retinopathy
* Risk factors for the development of glaucoma
21 Years
60 Years
ALL
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Federal University of São Paulo
Principal Investigators
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Tiago Arantes, MD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Federal University of São Paulo (UNIFESP/EPM)
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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BRA-713/06
Identifier Type: -
Identifier Source: org_study_id