Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification

Not Applicable

Completed

• Conditions: Posterior Capsule Opacification; Cataract
• Interventions: Procedure: bilateral cataract surgery

• Registration Number: NCT01936701
• Lead Sponsor: Medical University of Vienna

Brief Summary

Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-08
• Status Verified: 2013-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-06
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• bilateral age-related cataract
• good overall physical constitution

Exclusion Criteria

• previous intraocular surgery or ocular trauma
• intraocular complication like posterior capsular tear
• glaucoma
• uveitis
• corneal diseases, diabetic retinopathy and any other severe retinal -pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acrylic 3-piece IOL	bilateral cataract surgery	same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-XS in one eye
silicone 3-piece IOL	bilateral cataract surgery	same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-3Ai in one eye

Primary Outcome Measures

Name	Time	Method
posterior capsular opacification (PCO)	2 xears	subjective and objective PCO scoring

Secondary Outcome Measures

Name	Time	Method
best corrected visual acuity (BCVA)	2 years
Nd:YAG rate	2 years

Trial Locations

Locations (1)

Department of Ophthalmology and Optometry of the Medical University Vienna; 🇦🇹 Vienna, Austria