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RECRUITING
NCT07586787
NA

Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy

Sponsor: Xiamen Ophthalmology Center Affiliated to Xiamen University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether early microincision vitrectomy surgery (MIVS) can improve retinal neovascularization outcomes compared to standard pan-retinal photocoagulation (PRP) in patients with early proliferative diabetic retinopathy (PDR). It will also evaluate the safety and functional outcomes of early surgical intervention in this population. The main questions it aims to answer are: Does early MIVS increase the proportion of eyes achieving complete regression of retinal neovascularization at 12 months? Does early MIVS improve visual and functional outcomes, including visual acuity and visual field, compared to PRP? Researchers will compare early MIVS combined with peripheral scatter photocoagulation to standard PRP to determine whether early surgical intervention leads to better regression of neovascularization and improved clinical outcomes. Participants will: Receive either MIVS with peripheral photocoagulation or standard PRP Undergo retinal imaging assessments including fundus fluorescein angiography (FFA) or optical coherence tomography angiography (OCTA) Complete follow-up visits over 12 months, including visual acuity testing, visual field testing, and optical coherence tomography (OCT) imaging Be monitored for the occurrence of vitreous hemorrhage and other clinical outcomes

Official title: Comparison of Early Micro-invasive Vitrectomy Surgery Versus Panretinal Photocoagulation for the Treatment of Early Proliferative Diabetic Retinopathy: A Multi-center Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-01-01

Completion Date

2026-06-10

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

PROCEDURE

Microincision Vitrectomy Surgery

Panretinal photocoagulation delivered using standard laser therapy, consisting of approximately 1000 to 1500 laser burns applied over one or two sessions according to routine clinical practice.

PROCEDURE

Panretinal Photocoagulation

Panretinal photocoagulation delivered using standard laser therapy, consisting of approximately 1000 to 1500 laser burns applied over one or two sessions according to routine clinical practice.

Locations (6)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, China

Henan Province People's Hospital

Zhengzhou, Henan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Nanjing Medical University affiliated Eye Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China