Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage

Not Applicable

• Conditions: Branch Retinal Vein Occlusion; Vitrectomy; Anti-VEGF
• Interventions: Procedure: anti-VEGF; Procedure: fan-shaped photocoagulation

• Registration Number: NCT03637283
• Lead Sponsor: Wenzhou Medical University

Brief Summary

To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17
• Study Start: 2018-10-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age ≥ 18 years old;
2. BRVO is diagnosed
3. Vitreous hemorrhage
4. Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)

Exclusion Criteria

1. BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )
2. BRVO combined with retinal detachment
3. Retinal veins are completely whitened
4. iris neovascularization or neovascular glaucoma
5. Combined glaucoma
6. combined with other retinopathy
7. Received anti-VEGF treatment within 3 months before surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-VEGF	anti-VEGF	vitreoretinal surgery combined with intraoperative anti-VEGF
fan-shaped photocoagulation	fan-shaped photocoagulation	vitreoretinal surgery combined with fan-shaped photocoagulation

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in best-corrected visual acuity (BCVA)	3 years	Assessed using the ETDRS protocol

Secondary Outcome Measures

Name	Time	Method
chang from baseline in structure of retina	3 years	Assessed on Optical Coherence Tomography(OCT)
chang from baseline in retinal neovascularization	3 years	Assessed on Fundus Fluorescein Angiography(FFA)
Mean change from baseline in visual field	3 years	Assessed on Humphery(30-2 and 60-4)