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

• Conditions: Macular Edema Due to Diabetes Mellitus; Vitreous Hemorrhage

• Registration Number: NCT05529589
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-05
• Study First Posted: 2022-09-07
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06
• Study Start: 2023-02-10
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thickness change of retinal macular area	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)
Change of visual acuity	12 months	measurement of distance visual acuity with subjective refraction after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)

Secondary Outcome Measures

Name	Time	Method
Change of eye pressure	12 months	Measurement of contact tonometry with iCare TA01i tonometer after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
B-mode ultrasound imaging	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)

Trial Locations

Locations (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China