Last reviewed · How we verify

NCT04729023

Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients

Completed NA Last updated 9 September 2022
What this trial tests

NA trial testing Pars plana vitrectomy combined with cataract surgery. in Diabetic Retinopathy in 129 participants. Completed in 5 September 2022.

Timeline
1 February 2021
Primary endpoint
2 September 2022
5 September 2022

Quick facts

Lead sponsorZhongshan Ophthalmic Center, Sun Yat-sen University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment129
Start date1 February 2021
Primary completion2 September 2022
Estimated completion5 September 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Who can join

45 and older, any sex, with Diabetic Retinopathy or Diabetic Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness and safety of early lens extraction during par plana vitrectomy for proliferative diabetes retinopathy with mild cataract: a randomized clinical trial.
    Feng WB, Zheng L, Li YQ, Li YH, et al · · 2024 · cited 3× · PMID 38721515 · DOI 10.18240/ijo.2024.03.15
  2. Effectiveness and Safety of Vitrectomy Combined with Cataract Surgery Concurrently Versus Vitrectomy with Subsequent Cataract Surgery for Proliferative Diabetic Retinopathy Patients with Mild-moderate Cataract: A Multicenter Randomized Controlled Study
    feng w, Zheng L, Zhang G, wang x, et al · · 2023 · DOI 10.21203/rs.3.rs-2653898/v1

Verify or expand the search:

Other recruiting trials for Diabetic Retinopathy

Currently open trials in the same condition.

Other Zhongshan Ophthalmic Center, Sun Yat-sen University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04729023.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing