Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiamen Ophthalmology Center Affiliated to Xiamen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Disqualifiers
Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye.
Trial design
Design model
Parallel
Treatments tested in this trial
Microincision Vitrectomy Surgery
Procedure/SurgeryPanretinal 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
Procedure/SurgeryPanretinal 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Microincision Vitrectomy SurgeryExperimental treatment 1 intervention
Group B: Panretinal PhotocoagulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Eyes With Complete Regression of Neovascularization
Complete regression is defined as absence of neovascularization at the disc or neovascularization elsewhere in the retina, assessed by fundus fluorescein angiography or optical coherence tomography angiography.
Time frame
12 monthsSecondary outcomes
1
Proportion of Eyes With Partial Regression of Neovascularization
Partial regression is defined as reduction in retinal neovascularization compared with baseline, assessed by fundus fluorescein angiography or optical coherence tomography angiography.
Time frame
12 months2
Incidence of Vitreous Hemorrhage
Incidence of vitreous hemorrhage through 6/12 months after treatment.
Time frame
6 months；12 months3
Change in Visual Field
Change in visual field cumulative values measured using the 60-degree visual field test.
Time frame
Baseline to 12 months4
Change in Best Corrected Visual Acuity
Change in best corrected visual acuity measured using an ETDRS LogMAR chart.
Time frame
Baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiamen Ophthalmology Center Affiliated to Xiamen University
Lead sponsor
Jiangsu Provincial People's Hospital
Collaborator
Peking University People's Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Nanjing Medical University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Source ClinicalTrials.gov