Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy

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

Conditions

• Proliferative Diabetic Retinopathy (PDR)

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Xiamen Ophthalmology Center Affiliated to Xiamen University

  lead OTHER

Principal Investigators

• Xiaoxin Li, PhD · Xiamen Eye Center of Xiamen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2026-06-10

Completion

2026-06-10

Countries

• China

Study Locations