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Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Sponsor: Xiamen Ophthalmology Center Affiliated to Xiamen University
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
Conditions
Interventions
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.
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