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

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ClinicalTrials.gov Identifier: NCT04729023

Recruitment Status : Recruiting

First Posted : January 28, 2021

Last Update Posted : February 10, 2022

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Sponsor:

Information provided by (Responsible Party):

Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Retinopathy Diabetic Cataract	Procedure: Pars plana vitrectomy combined with cataract surgery. Procedure: Pars plana vitrectomy with subsequent cataract surgery.	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	122 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	February 1, 2021
Estimated Primary Completion Date :	October 1, 2022
Estimated Study Completion Date :	December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Diabetic Eye Problems Retinal Disorders

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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
Best correct visual acuity [ Time Frame: Change from Baseline at 1 month after the surgery(s) ]
BCVA with ETDRS letters
Best correct visual acuity [ Time Frame: Change from Baseline at 3 months after the surgery(s) ]
BCVA with ETDRS letters
Best correct visual acuity [ Time Frame: Change from Baseline at 6 months after the surgery(s) ]
BCVA with ETDRS letters

Secondary Outcome Measures :

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
Complications [ Time Frame: through study completion, an average of 1 year ]
Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
Treatment costs [ Time Frame: through study completion, an average of 1 year ]
The amount of money paid on the surgery(s) by each patient.
Working delay time [ Time Frame: through study completion, an average of 1 year ]
The working delay time due to the surgery(s).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729023

Contacts

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Contact: Mingxing Wu, Ph.D	+86-13822119558	wumingx@mail.sysu.edu.cn

Locations

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China, Guangdong
Zhongshan Ophthalmic center, Sun Yat-sen University	Recruiting
Guangzhou, Guangdong, China, 550000
Contact: weibo feng feng_weibo@126.com

Sponsors and Collaborators

Zhongshan Ophthalmic Center, Sun Yat-sen University

More Information

Publications:

Novak MA, Rice TA, Michels RG, Auer C. The crystalline lens after vitrectomy for diabetic retinopathy. Ophthalmology. 1984 Dec;91(12):1480-4.

Hsuan JD, Brown NA, Bron AJ, Patel CK, Rosen PH. Posterior subcapsular and nuclear cataract after vitrectomy. J Cataract Refract Surg. 2001 Mar;27(3):437-44.

Melberg NS, Thomas MA. Nuclear sclerotic cataract after vitrectomy in patients younger than 50 years of age. Ophthalmology. 1995 Oct;102(10):1466-71.

Blodi BA, Paluska SA. Cataract after vitrectomy in young patients. Ophthalmology. 1997 Jul;104(7):1092-5.

Westesson PL, Lundh H. Temporomandibular joint disk displacement: arthrographic and tomographic follow-up after 6 months' treatment with disk-repositioning onlays. Oral Surg Oral Med Oral Pathol. 1988 Sep;66(3):271-8.

Soto-Hernandez JL, Nunley D, Gutierrez CC, Berk SL. Listeria monocytogenes peritonitis. Am J Gastroenterol. 1988 Feb;83(2):180-2.

Peyman GA, Huamonte F, Goldberg MF. Management of cataract in patients undergoing vitrectomy. Am J Ophthalmol. 1975 Jul;80(1):30-6.

Treumer F, Bunse A, Rudolf M, Roider J. Pars plana vitrectomy, phacoemulsification and intraocular lens implantation. Comparison of clinical complications in a combined versus two-step surgical approach. Graefes Arch Clin Exp Ophthalmol. 2006 Jul;244(7):808-15. Epub 2005 Dec 3.

Biró Z, Kovacs B. Results of cataract surgery in previously vitrectomized eyes. J Cataract Refract Surg. 2002 Jun;28(6):1003-6.

Meyers SM, Klein R, Chandra S, Myers FL. Unplanned extracapsular cataract extraction in postvitrectomy eyes. Am J Ophthalmol. 1978 Nov;86(5):624-6.

Smiddy WE, Stark WJ, Michels RG, Maumenee AE, Terry AC, Glaser BM. Cataract extraction after vitrectomy. Ophthalmology. 1987 May;94(5):483-7.

Senn P, Schipper I, Perren B. Combined pars plana vitrectomy, phacoemulsification, and intraocular lens implantation in the capsular bag: a comparison to vitrectomy and subsequent cataract surgery as a two-step procedure. Ophthalmic Surg Lasers. 1995 Sep-Oct;26(5):420-8.

Silva PS, Diala PA, Hamam RN, Arrigg PG, Shah ST, Murtha TL, Schlossman DK, Cavallerano JD, Sun JK, Aiello LP. Visual outcomes from pars plana vitrectomy versus combined pars plana vitrectomy, phacoemulsification, and intraocular lens implantation in patients with diabetes. Retina. 2014 Oct;34(10):1960-8. doi: 10.1097/IAE.0000000000000171.

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Responsible Party:	Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT04729023
Other Study ID Numbers:	2020KYPJ167
First Posted:	January 28, 2021 Key Record Dates
Last Update Posted:	February 10, 2022
Last Verified:	February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Keywords provided by Zhongshan Ophthalmic Center, Sun Yat-sen University:


Diabetic Retinopathy Diabetic Cataract Pars plana vitrectomy Phacoemulsification

Additional relevant MeSH terms:

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Cataract Retinal Diseases Diabetic Retinopathy Lens Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases	Temazepam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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