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

Qualifiers

Age 18 years or older.

Disqualifiers

Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye.

Trial design

Treatments tested in this trial

  • Microincision Vitrectomy Surgery
  • Panretinal Photocoagulation

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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