Suprachoroidal Hemorrhage (Diagnosis)NCT05013281
Suprachoroidal Hemorrhage Associated With Pars Plana Vitrectomy
An observational study of Suprachoroidal Hemorrhage (Diagnosis) and Pars Plana Vitrectomy, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
To analyze the characteristics, related risk factors, and prognosis of suprachoroidal hemorrhage (SCH) associated with pars plana vitrectomy (PPV). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suprachoroidal Hemorrhage (Diagnosis), Pars Plana Vitrectomy
- What is being tested?
- Suprachoroidal hemorrhage associated with pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 28 Jan 2021
- 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: any participants who treated with PPV and occured Suprachoroidal hemorrhage with PPV
Who may be able to join
- Suprachoroidal hemorrhage associated with pars plana vitrectomy
Who cannot join
- Patients with eye trauma-related Suprachoroidal hemorrhage were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
To analyze the characteristics, related risk factors, and prognosis of suprachoroidal hemorrhage (SCH) associated with pars plana vitrectomy (PPV).
- Being tested
- Suprachoroidal hemorrhage associated with pars plana vitrectomy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprachoroidal hemorrhage associated with pars plana vitrectomyProcedure or surgery
SCH has a higher incidence rate after a second intraocular surgery in a vitrectomized eye which is associated with the lack of vitreous support and easier fluctuation of intraocular pressure. SCH associated with PPV is more localized and has a relatively good prognosis; high myopia and aphakic/ pseudophakic eyes are risk factors. Active treatment can effectively improve visual prognosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
pathogenesis
pathogenesis of PPV-related SCH and incidence of PPV-related SCH
Measured: baseline
Secondary outcomes (1)
vision acuity
the final vision acuity
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jan 2010
- Primary completion30 Jun 2020
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suprachoroidal Hemorrhage (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013281
- Sponsor's protocol ID
- TR2021SCH
- Status last verified
- Jul 2021
- First submitted
- 11 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprachoroidal Hemorrhage Associated With Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT05013281
- Acronym / sponsor ID
- TR2021SCH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 19 Aug 2021 (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.
To analyze the characteristics, related risk factors, and prognosis of suprachoroidal hemorrhage (SCH) associated with pars plana vitrectomy (PPV).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- any participants who treated with PPV and occured Suprachoroidal hemorrhage with PPV
Key inclusion criteria (1 listed)
- Suprachoroidal hemorrhage associated with pars plana vitrectomy
Key exclusion criteria (1 listed)
- Patients with eye trauma-related Suprachoroidal hemorrhage were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprachoroidal hemorrhage associated with pars plana vitrectomySCH has a higher incidence rate after a second intraocular surgery in a vitrectomized eye which is associated with the lack of vitreous support and easier fluctuation of intraocular pressure. SCH associated with PPV is more localized and has a relatively good prognosis; high myopia and aphakic/ pseudophakic eyes are risk factors. Active treatment can effectively improve visual prognosis. | Procedure or surgery | – |
Primary outcome
pathogenesis
Time frame: baseline
pathogenesis of PPV-related SCH and incidence of PPV-related SCH
1 secondary outcome
vision acuity
Time frame: up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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 Suprachoroidal Hemorrhage (Diagnosis) and Pars Plana Vitrectomy, run by Beijing Tongren 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: finished, as of the sponsor's last update on 19 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pathogenesis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2021.