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

NCT05529589 | Unknown

• 1 other identifier: AVDME
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Macular Edema Due to Diabetes Mellitus; Vitreous Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Thickness change of retinal macular area

  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

  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 Outcomes (2)

• Change of eye pressure

  12 months

• B-mode ultrasound imaging

  12 months

Study Arms (2)

control group

Diabetic macular edema patient with inner limit membrane

experimental group

Diabetic macular edema patient with inner limit membrane peeling

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
• The patient with a history of anti-VEGF therapy
• Patients with DME in the contralateral eye requiring anti-VEGF therapy
• Patients with contraindications of vitreous cavity resection
• The patient has a history of intraocular surgery
• The patient has active inflammatory disease
• The patient has other retinal diseases that affect vision
• The patient has other systemic diseases that required treatment with anti-VEGF drugs
• Patient with contraindications to anti-VEGF therapy

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Vitreous Hemorrhage

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jian Ma, Doctor

CONTACT

18858299889; jian_ma@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: February 10, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 6, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)