Vitrectomy Clinical Trials

Clinical trials related to Vitrectomy Procedure

Comparison of Early Micro-invasive Vitrectomy Surgery Versus Panretinal Photocoagulation for the Treatment of Early Proliferative Diabetic Retinopathy: A Multi-center Randomized Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University People's Hospital
COMPLETED
Beijing
The First Affiliated Hospital of Dalian Medical University
COMPLETED
Dalian
Jiangsu Provincial People's Hospital
COMPLETED
Nanjing
Nanjing Medical University affiliated Eye Hospital
COMPLETED
Nanjing
Xiamen Eye Center of Xiamen University
RECRUITING
Xiamen
Henan Province People's Hospital
COMPLETED
Zhengzhou
Contact Information
Primary
xiuju Chen, md
joyychen@aliyun.com
+8618060955810
Backup
wenjie huang
xmykec@huaxiaeye.com
+8618150139807
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-06-10
Participants
Target number of participants: 100
Treatments
Experimental: Microincision Vitrectomy Surgery
Participants undergo early microincision vitrectomy surgery (MIVS) using small-gauge instrumentation (25G or 27G) with high-speed vitreous removal. During surgery, scattered photocoagulation is applied to the far peripheral retina.
Active_comparator: Panretinal Photocoagulation
Participants receive standard panretinal photocoagulation (PRP) according to routine clinical practice. Treatment consists of approximately 1000 to 1500 laser burns delivered over one or two sessions within several weeks after randomization.
Related Therapeutic Areas
Sponsors
Collaborators: Peking University People's Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Dalian Medical University, Jiangsu Provincial People's Hospital, Nanjing Medical University
Leads: Xiamen Ophthalmology Center Affiliated to Xiamen University

This content was sourced from clinicaltrials.gov