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

Study Overview
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Brief Summary
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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.

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

Conditions
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Posterior Capsule Opacification, Cataract

Intervention / Treatment
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* Procedure: bilateral cataract surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: acrylic 3-piece IOL<br>same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-XS in one eye | Procedure: bilateral cataract surgery<br>* same-day bilateral cataract surgery with implantation of intraocular lens<br>|
| Other: silicone 3-piece IOL<br>same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-3Ai in one eye | Procedure: bilateral cataract surgery<br>* same-day bilateral cataract surgery with implantation of intraocular lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| posterior capsular opacification (PCO) | subjective and objective PCO scoring | 2 xears | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity (BCVA) |  | 2 years | 
| Nd:YAG rate |  | 2 years |