Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and UveitisNCT06250881
Analysis of Ocular Complications of AIDS Patients in Ophthalmic Consultation
An observational study of Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and Uveitis, run by Zhongnan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and Uveitis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- AIDS inpatient undergoing ophthalmic consultation
Who cannot join
- Non-hiv infected patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Ocular complications of AIDS
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
fundus photo changes
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.
Measured: The classification was based on a review of the fundus examination of the patient at the time of the 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Oct 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250881
- Sponsor's protocol ID
- 20231119
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25448999De 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.
PubMed 34013858Landovitz 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.
PubMed 37344551Bekker 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.
PubMed 37591865Cohn 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.
PubMed 32272077
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ocular Complications of AIDS Patients in Ophthalmic Consultation
- ClinicalTrials.gov ID
- NCT06250881
- Acronym / sponsor ID
- 20231119
- Keywords
- Ocular complications of AIDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Mar 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- AIDS inpatient undergoing ophthalmic consultation
Key exclusion criteria (1 listed)
- Non-hiv infected patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Results publication: PubMed 25448999Yen 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.
- Results publication: PubMed 34013858De 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.
- Results publication: PubMed 37344551Landovitz 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.
- Results publication: PubMed 37591865Bekker 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.
- Results publication: PubMed 32272077Cohn 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and Uveitis, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250881, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.