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

September 8, 2022 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of diabetes retinopathy is increasing dramatically recent years. 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.Generally, subsequent cataract surgeries are required for the phakic patients within 6-16 months after the PPV surgery to improve visualization. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks because of the deep anterior chamber, zonular dehiscence, and inflammation. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option, which is only suggested in patients with severe lens opacities before the PPV surgery so far. For those with mild-moderate lens opacities, the benefits of combined surgery is unknown.

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 Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 550000
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Proliferative diabetes retinopathy ;
  2. Age over 45 years old;
  3. mild-moderate lens opacities(LOCSⅢ : C3N3P3 or below);
  4. recognition of at least one alphabet in ETDRS chart.

Exclusion Criteria:

  1. Long-standing retinal detachment (more than three months), macular affected
  2. Low Vision or blind on the other eye;
  3. Macular degeneration, including age-related macular degeneration and Polypoidal choroidal vasculopathy;
  4. Ocular trauma;
  5. Glaucoma;
  6. Hereditary retinopathy;
  7. Severe lens opacities before the surgery (LOCSⅢ : C4N4P4 or above).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined surgery group
In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery.
Procedure: Pars plana vitrectomy combined with cataract surgery.
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.
Active Comparator: Subsequent surgery group
In this group, all eligible patients will receive pars plana vitrectomy first. And a subsequent phacoemulsification will be systematically performed 6 months after the PPV surgery.
Procedure: Pars plana vitrectomy with subsequent cataract surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best correct visual acuity (BCVA)
Time Frame: Change from Baseline at 1 week after the surgery(s)
BCVA with early treatment diabetic retinopathy study (ETDRS) letters
Change from Baseline at 1 week after the surgery(s)
Best correct visual acuity
Time Frame: Change from Baseline at 1 month after the surgery(s)
BCVA with ETDRS letters
Change from Baseline at 1 month after the surgery(s)
Best correct visual acuity
Time Frame: Change from Baseline at 3 months after the surgery(s)
BCVA with ETDRS letters
Change from Baseline at 3 months after the surgery(s)
Best correct visual acuity
Time Frame: Change from Baseline at 6 months after the surgery(s)
BCVA with ETDRS letters
Change from Baseline at 6 months after the surgery(s)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VFQ-25 score
Time Frame: Change from Baseline at 6 months after the surgery(s).
Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome
Change from Baseline at 6 months after the surgery(s).
Complications
Time Frame: through study completion, an average of 1 year
Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
through study completion, an average of 1 year
Treatment costs
Time Frame: through study completion, an average of 1 year
The amount of money paid on the surgery(s) by each patient.
through study completion, an average of 1 year
Working delay time
Time Frame: through study completion, an average of 1 year
The working delay time due to the surgery(s).
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

September 5, 2022

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020KYPJ167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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