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

February 2, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Comparative Study of 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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • 2ndAffiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with vitreous hemorrhage with DME who need vitreous surgery are of all ages and sexes

Description

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

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
control group
Diabetic macular edema patient with inner limit membrane
experimental group
Diabetic macular edema patient with inner limit membrane peeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness change of retinal macular area
Time Frame: 12 months
measurement of thickness of retinal macular area with macular optical coherence tomography after operation (0 day, 1 week, 1 months, 3 months, 6 months, 12 months)
12 months
Change of visual acuity
Time Frame: 12 months
measurement of distance visual acuity with subjective refraction after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of eye pressure
Time Frame: 12 months
Measurement of contact tonometry with iCare TA01i tonometer after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
12 months
B-mode ultrasound imaging
Time Frame: 12 months
Existing or not of abnormal anatomical structure in posterior eye segment (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (ANTICIPATED)

February 10, 2023

Primary Completion (ANTICIPATED)

October 30, 2023

Study Completion (ANTICIPATED)

October 30, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (ACTUAL)

September 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVDME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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