Comparison of Restoration in Vitreous Hemorrhage Patients With DME After or Not Removing Inner Limiting Membrane

NCT ID: NCT05529589

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-10

Study Completion Date

2023-10-30

Brief Summary

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This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not

Detailed Description

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Conditions

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Macular Edema Due to Diabetes Mellitus Vitreous Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

Diabetic macular edema patient with inner limit membrane

No interventions assigned to this group

experimental group

Diabetic macular edema patient with inner limit membrane peeling

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery

Exclusion Criteria

1. The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
2. The patient with a history of anti-VEGF therapy
3. Patients with DME in the contralateral eye requiring anti-VEGF therapy
4. Patients with contraindications of vitreous cavity resection
5. The patient has a history of intraocular surgery
6. The patient has active inflammatory disease
7. The patient has other retinal diseases that affect vision
8. The patient has other systemic diseases that required treatment with anti-VEGF drugs
9. Patient with contraindications to anti-VEGF therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Ma, Doctor

Role: CONTACT

18858299889

Facility Contacts

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Jian Ma, Doctor

Role: primary

18858299889

Other Identifiers

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AVDME

Identifier Type: -

Identifier Source: org_study_id

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