- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250881
Analysis of Ocular Complications of AIDS Patients in Ophthalmic Consultation
February 8, 2024 updated by: Zhongnan Hospital
Through a cross-sectional descriptive analysis of ophthalmic consultation of AIDS patients in the past 3 years, the basic characteristics of patients were described according to whether there was fundus change, and the clinical characteristics and risk factors of CMVR patients with or without RD were compared.
Study Overview
Status
Active, not recruiting
Detailed Description
Patients were divided into normal group, opportunistic infection group, microangiopathopathy group and uveitis group according to the presence of fundus lesions and the types of fundus lesions.
The basic information and characteristics of patients in different groups were described.
The factors that may be related to ocular fundus disease of AIDS patients were found by statistical analysis.
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Zhongnan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
HIV/AIDS patients hospitalized in the infection department at ZhongNan Hospital with ophthalmic consultation during November 19th, 2019 to June 9th ,2023 were included.
Description
Inclusion Criteria:
- AIDS inpatient undergoing ophthalmic consultation
Exclusion Criteria:
- Non-hiv infected patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
without ocular complication
The normal group was compared with the pathological group
|
fundus opportunistic infections
AIDS patients are prone to opportunistic fundus infection, which show a characteristic changes in fundus photography.
It was designed to describe the characteristics of this group of patients.
|
Microvascular disease
Microvascular disease is an early characteristic of fundus changes in AIDS patients, with characteristic changes in fundus photography.
|
uveitis
The uveitis patients in this study were mainly caused by treponema pallidum infection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fundus photo changes
Time Frame: The classification was based on a review of the fundus examination of the patient at the time of the 1 day visit
|
Early changes(microangiopathy) appear as small, white, scattered retinal infiltrations.
And the typical change of CMVR is full-layer, cheesy retinal necrosis with extensive retinal bleeding in the distal region.
|
The classification was based on a review of the fundus examination of the patient at the time of the 1 day visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yen M, Chen J, Ausayakhun S, Kunavisarut P, Vichitvejpaisal P, Ausayakhun S, Jirawison C, Shantha J, Holland GN, Heiden D, Margolis TP, Keenan JD. Retinal detachment associated with AIDS-related cytomegalovirus retinitis: risk factors in a resource-limited setting. Am J Ophthalmol. 2015 Jan;159(1):185-92. doi: 10.1016/j.ajo.2014.10.014. Epub 2014 Oct 22.
- De Cock KM, Jaffe HW, Curran JW. Reflections on 40 Years of AIDS. Emerg Infect Dis. 2021 Jun;27(6):1553-1560. doi: 10.3201/eid2706.210284.
- Landovitz RJ, Scott H, Deeks SG. Prevention, treatment and cure of HIV infection. Nat Rev Microbiol. 2023 Oct;21(10):657-670. doi: 10.1038/s41579-023-00914-1. Epub 2023 Jun 21.
- Bekker LG, Beyrer C, Mgodi N, Lewin SR, Delany-Moretlwe S, Taiwo B, Masters MC, Lazarus JV. HIV infection. Nat Rev Dis Primers. 2023 Aug 17;9(1):42. doi: 10.1038/s41572-023-00452-3. Erratum In: Nat Rev Dis Primers. 2023 Sep 11;9(1):48.
- Cohn LB, Chomont N, Deeks SG. The Biology of the HIV-1 Latent Reservoir and Implications for Cure Strategies. Cell Host Microbe. 2020 Apr 8;27(4):519-530. doi: 10.1016/j.chom.2020.03.014.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
February 28, 2024
Study Completion (Estimated)
March 28, 2024
Study Registration Dates
First Submitted
February 1, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Actual)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20231119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and Uveitis
-
Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research... and other collaboratorsRecruitingMitochondrial Diseases | Retinitis Pigmentosa | Myasthenia Gravis | Eosinophilic Gastroenteritis | Multiple System Atrophy | Leiomyosarcoma | Leukodystrophy | Anal Fistula | Spinocerebellar Ataxia Type 3 | Friedreich Ataxia | Kennedy Disease | Lyme Disease | Hemophagocytic Lymphohistiocytosis | Spinocerebellar Ataxia... and other conditionsUnited States, Australia