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

Vitreous Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529589
• Other study ID #: AVDME
• Status: Recruiting
• Start date: February 10, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jian Ma, Doctor
• Phone: 18858299889
• Email: jian_ma[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Macular Edema
• Macular Edema Due to Diabetes Mellitus
• Vitreous Hemorrhage

Locations

Country	Name	City	State
China	2ndAffiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change of eye pressure	Measurement of contact tonometry with iCare TA01i tonometer after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)	12 months
Secondary	B-mode ultrasound imaging	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