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

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729023
• Other study ID #: 2020KYPJ167
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: September 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 5, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Proliferative diabetes retinopathy ;

2. Age over 45 years old;

3. mild-moderate lens opacities(LOCS? : 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 (LOCS? : C4N4P4 or above).

Related Conditions & MeSH terms

• Cataract
• Diabetic Cataract
• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (13)

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

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

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. — View Citation

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

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

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

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best correct visual acuity (BCVA)	BCVA with early treatment diabetic retinopathy study (ETDRS) letters	Change from Baseline at 1 week after the surgery(s)
Primary	Best correct visual acuity	BCVA with ETDRS letters	Change from Baseline at 1 month after the surgery(s)
Primary	Best correct visual acuity	BCVA with ETDRS letters	Change from Baseline at 3 months after the surgery(s)
Primary	Best correct visual acuity	BCVA with ETDRS letters	Change from Baseline at 6 months after the surgery(s)
Secondary	VFQ-25 score	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).
Secondary	Complications	Common complications after the surgery like glaucoma, macular edema, iritis, et. al.	through study completion, an average of 1 year
Secondary	Treatment costs	The amount of money paid on the surgery(s) by each patient.	through study completion, an average of 1 year
Secondary	Working delay time	The working delay time due to the surgery(s).	through study completion, an average of 1 year