CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 129 enrolled
Drug / intervention
Pars plana vitrectomy combined with cataract surgery. +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04729023
NCT04729023N/ACompleted

The Effect of Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients Over 45 Years Old: a Multicenter Randomized Controlled Clinical Study

Zhongshan Ophthalmic Center, Sun Yat-sen University·interventional·Posted Jan 28, 2021·Updated Sep 9, 2022

In Brief

A clinical study evaluating Pars plana vitrectomy combined with cataract surgery. and Pars plana vitrectomy with subsequent cataract surgery. for Diabetic Retinopathy and Diabetic Cataract. Completed, enrolled 129 participants across 1 site.

Detailed Summary

Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world. However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months and a subsequent cataract surgery is usually required. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option. This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 28, 2021
Enrollment StartFeb 1, 2021
Primary CompletionSep 2, 2022
Study CompletionSep 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.4 years ago

Interventions

Pars plana vitrectomy combined with cataract surgery.procedure

In the combined surgery group, phakic diabetes retinopathy patients over 45 years old without severe lens opacity will receive pars plana vitrectomy combined with phacoemulsification and intraocular lens (IOL) implantation at the same time.

Pars plana vitrectomy with subsequent cataract surgery.procedure

In the control group, phakic diabetes retinopathy patients over 45 years old without severe lens opacity will first receive pars plana vitrectomy and a subsequent phacoemulsification with IOL implantation will be performed at least 6 month after the PPV.