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

NCT04729023 | Completed

• 1 other identifier: 2020KYPJ167
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Diabetic Cataract

Keywords

Diabetic Retinopathy; Diabetic Cataract; Pars plana vitrectomy; Phacoemulsification

Outcome Measures

Primary Outcomes (4)

• Best correct visual acuity (BCVA)

  BCVA with early treatment diabetic retinopathy study (ETDRS) letters

  Change from Baseline at 1 week after the surgery(s)

• Best correct visual acuity

  BCVA with ETDRS letters

  Change from Baseline at 1 month after the surgery(s)

• Best correct visual acuity

  BCVA with ETDRS letters

  Change from Baseline at 3 months after the surgery(s)

• Best correct visual acuity

  BCVA with ETDRS letters

  Change from Baseline at 6 months after the surgery(s)

Secondary Outcomes (4)

• VFQ-25 score

  Change from Baseline at 6 months after the surgery(s).

• Complications

  through study completion, an average of 1 year

• Treatment costs

  through study completion, an average of 1 year

• Working delay time

  through study completion, an average of 1 year

Study Arms (2)

Combined surgery group

EXPERIMENTAL

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

Procedure: Pars plana vitrectomy combined with cataract surgery.

Subsequent surgery group

ACTIVE COMPARATOR

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.

Interventions

Pars plana vitrectomy combined with cataract surgery. PROCEDURE

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.

Combined surgery group

Pars plana vitrectomy with subsequent cataract surgery. PROCEDURE

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.

Subsequent surgery group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 550000, China

Location

Related Publications (13)

• Novak MA, Rice TA, Michels RG, Auer C. The crystalline lens after vitrectomy for diabetic retinopathy. Ophthalmology. 1984 Dec;91(12):1480-4. doi: 10.1016/s0161-6420(84)34100-8.

  PMID: 6521988 BACKGROUND

• 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. doi: 10.1016/s0886-3350(00)00585-x.

  PMID: 11255058 BACKGROUND

• 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.

  PMID: 9097793 BACKGROUND

• Blodi BA, Paluska SA. Cataract after vitrectomy in young patients. Ophthalmology. 1997 Jul;104(7):1092-5. doi: 10.1016/s0161-6420(97)30180-8.

  PMID: 9224458 BACKGROUND

• 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. doi: 10.1016/0030-4220(88)90230-7.

  PMID: 3174063 BACKGROUND

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

  PMID: 3341344 BACKGROUND

• Peyman GA, Huamonte F, Goldberg MF. Management of cataract in patients undergoing vitrectomy. Am J Ophthalmol. 1975 Jul;80(1):30-6. doi: 10.1016/0002-9394(75)90864-8.

  PMID: 1155546 BACKGROUND

• 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. doi: 10.1007/s00417-005-0146-9. Epub 2005 Dec 3.

  PMID: 16328429 BACKGROUND

• Biro Z, Kovacs B. Results of cataract surgery in previously vitrectomized eyes. J Cataract Refract Surg. 2002 Jun;28(6):1003-6. doi: 10.1016/s0886-3350(02)01237-3.

  PMID: 12036644 BACKGROUND

• Meyers SM, Klein R, Chandra S, Myers FL. Unplanned extracapsular cataract extraction in postvitrectomy eyes. Am J Ophthalmol. 1978 Nov;86(5):624-6. doi: 10.1016/0002-9394(78)90179-4.

  PMID: 309730 BACKGROUND

• Smiddy WE, Stark WJ, Michels RG, Maumenee AE, Terry AC, Glaser BM. Cataract extraction after vitrectomy. Ophthalmology. 1987 May;94(5):483-7. doi: 10.1016/s0161-6420(87)33420-7.

  PMID: 3601363 BACKGROUND

• 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.

  PMID: 8963856 BACKGROUND

• 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.

  PMID: 24830822 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: February 1, 2021
• Primary Completion: September 2, 2022
• Study Completion: September 5, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)