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

Primary Purpose

Diabetic Retinopathy, Diabetic Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pars plana vitrectomy combined with cataract surgery.
Pars plana vitrectomy with subsequent cataract surgery.
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Diabetic Cataract, Pars plana vitrectomy, Phacoemulsification

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Zhongshan Ophthalmic center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined surgery group

Subsequent surgery group

Arm Description

In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery.

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.

Outcomes

Primary Outcome Measures

Best correct visual acuity (BCVA)
BCVA with early treatment diabetic retinopathy study (ETDRS) letters
Best correct visual acuity
BCVA with ETDRS letters
Best correct visual acuity
BCVA with ETDRS letters
Best correct visual acuity
BCVA with ETDRS letters

Secondary Outcome Measures

VFQ-25 score
Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome
Complications
Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
Treatment costs
The amount of money paid on the surgery(s) by each patient.
Working delay time
The working delay time due to the surgery(s).

Full Information

First Posted
January 21, 2021
Last Updated
September 8, 2022
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04729023
Brief Title
Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetic Cataract
Keywords
Diabetic Retinopathy, Diabetic Cataract, Pars plana vitrectomy, Phacoemulsification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined surgery group
Arm Type
Experimental
Arm Description
In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery.
Arm Title
Subsequent surgery group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy combined with cataract surgery.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy with subsequent cataract surgery.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best correct visual acuity (BCVA)
Description
BCVA with early treatment diabetic retinopathy study (ETDRS) letters
Time Frame
Change from Baseline at 1 week after the surgery(s)
Title
Best correct visual acuity
Description
BCVA with ETDRS letters
Time Frame
Change from Baseline at 1 month after the surgery(s)
Title
Best correct visual acuity
Description
BCVA with ETDRS letters
Time Frame
Change from Baseline at 3 months after the surgery(s)
Title
Best correct visual acuity
Description
BCVA with ETDRS letters
Time Frame
Change from Baseline at 6 months after the surgery(s)
Secondary Outcome Measure Information:
Title
VFQ-25 score
Description
Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome
Time Frame
Change from Baseline at 6 months after the surgery(s).
Title
Complications
Description
Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
Time Frame
through study completion, an average of 1 year
Title
Treatment costs
Description
The amount of money paid on the surgery(s) by each patient.
Time Frame
through study completion, an average of 1 year
Title
Working delay time
Description
The working delay time due to the surgery(s).
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Proliferative diabetes retinopathy ; Age over 45 years old; mild-moderate lens opacities(LOCSⅢ : C3N3P3 or below); recognition of at least one alphabet in ETDRS chart. Exclusion Criteria: Long-standing retinal detachment (more than three months), macular affected Low Vision or blind on the other eye; Macular degeneration, including age-related macular degeneration and Polypoidal choroidal vasculopathy; Ocular trauma; Glaucoma; Hereditary retinopathy; Severe lens opacities before the surgery (LOCSⅢ : C4N4P4 or above).
Facility Information:
Facility Name
Zhongshan Ophthalmic center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
550000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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6521988
Citation
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Melberg NS, Thomas MA. Nuclear sclerotic cataract after vitrectomy in patients younger than 50 years of age. Ophthalmology. 1995 Oct;102(10):1466-71. doi: 10.1016/s0161-6420(95)30844-5.
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Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients

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