Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Comparison of Early Micro-invasive Vitrectomy Surgery Versus Panretinal Photocoagulation for the Treatment of Early Proliferative Diabetic Retinopathy: A Multi-center Randomized Trial
Xiamen Ophthalmology Center Affiliated to Xiamen University
100 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus.
- Presence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does not interfere with evaluation of neovascularization.
- Relatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal 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.
Exclusion Criteria19
- 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 decrease 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.
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Interventions
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 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)
View Full Details on ClinicalTrials.gov
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NCT07586787