Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

Study Overview
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Brief Summary
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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).

Official Title
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Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients Using Optical Coherence Tomography and Frequency Doubling Technology Perimetry

Conditions
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HIV Infections, Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Device: Optical Coherence Tomography (OCT)
* Device: Frequency Doubling Technology (FDT) perimeter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>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)<br>* Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls<br>Device: Frequency Doubling Technology (FDT) perimeter<br>* 24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.<br>|
| B<br>HIV-positive patients with CD4 cell counts never below 100 cells/mm³ in their medical records | Device: Optical Coherence Tomography (OCT)<br>* Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls<br>Device: Frequency Doubling Technology (FDT) perimeter<br>* 24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.<br>|
| C<br>HIV-negative patients (control group) | Device: Optical Coherence Tomography (OCT)<br>* Macular and retinal nerve fiber layer OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) will be performed both in patients and controls<br>Device: Frequency Doubling Technology (FDT) perimeter<br>* 24-2 FDT Threshold (Humphrey Matrix, Carl Zeiss Meditec, Dublin CA; Welch-Allyn, Skaneateles, NY) will be performed both in patients and controls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |