Trial record 12 of 34 for:
" March 11, 2009":" April 10, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients
This study has been completed.
Sponsor:
Federal University of São Paulo
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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:
|
Acquired Immunodeficiency Syndrome HIV Infections HIV Seropositivity Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013