NCT05013281

Brief Summary

To analyze the characteristics, related risk factors, and prognosis of suprachoroidal hemorrhage (SCH) associated with pars plana vitrectomy (PPV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
Last Updated

August 19, 2021

Status Verified

July 1, 2021

Enrollment Period

10.5 years

First QC Date

August 11, 2021

Last Update Submit

August 17, 2021

Conditions

Suprachoroidal Hemorrhage (Diagnosis)Pars Plana Vitrectomy

Outcome Measures

Primary Outcomes (1)

  • pathogenesis

    pathogenesis of PPV-related SCH and incidence of PPV-related SCH

    baseline

Secondary Outcomes (1)

  • vision acuity

    up to 7 weeks

Interventions

Suprachoroidal hemorrhage associated with pars plana vitrectomyPROCEDURE

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

any participants who treated with PPV and occured Suprachoroidal hemorrhage with PPV

You may qualify if:

  • Suprachoroidal hemorrhage associated with pars plana vitrectomy

You may not qualify if:

  • Patients with eye trauma-related Suprachoroidal hemorrhage were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 19, 2021

Study Start

January 1, 2010

Primary Completion

June 30, 2020

Study Completion

January 28, 2021

Last Updated

August 19, 2021

Record last verified: 2021-07

Locations

CN(1)