Actively Recruiting
Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Led by Xiamen Ophthalmology Center Affiliated to Xiamen University · Updated on 2026-05-14
100
Participants Needed
6
Research Sites
75 weeks
Total Duration
On this page
Sponsors
X
Xiamen Ophthalmology Center Affiliated to Xiamen University
Lead Sponsor
J
Jiangsu Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of type 2 diabetes mellitus
- Presence of early proliferative diabetic retinopathy with active neovascularization or mild vitreous or preretinal hemorrhage not interfering with neovascularization evaluation
- Clear optical media with good pupil dilation and cooperation for photocoagulation and retinal imaging
- Ability and willingness to provide written informed consent
- If both eyes are eligible, the eye with worse vision will be included
You will not qualify if you...
- Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye
- Retinal traction or retinal detachment
- Optic neuropathy
- Macular edema caused by reasons other than diabetes
- Coexisting ocular disease that may decrease visual acuity during the study
- Substantial cataract likely to reduce visual acuity by more than three lines
- Major ocular surgery within the past 4 months or planned intraocular surgery within the next 6 months
- YAG capsulotomy within the past 2 months
- Any intravitreal injection within the past 3 months
- Aphakia
- Severe external ocular infection
- Uncontrolled glaucoma
- Significant renal disease requiring dialysis or kidney transplantation
- Unstable glycemic control
- Blood pressure greater than 180/110 mmHg
- History of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac event requiring hospitalization within the past 4 months
- Pregnant, lactating, or intending to become pregnant during the study period
- Participation in another clinical trial
- Unwilling or unable to provide informed consent, undergo randomization, or return for scheduled visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Completed
2
Xiamen Eye Center of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
3
Henan Province People's Hospital
Zhengzhou, Henan, China
Completed
4
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Completed
5
Nanjing Medical University affiliated Eye Hospital
Nanjing, Jiangsu, China
Completed
6
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Completed
Research Team
X
xiuju Chen, md
CONTACT
W
wenjie huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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