Posterior Capsule Opacification Study

Study Overview
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Brief Summary
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First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different

Detailed Description
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Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL) The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA) 100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.

Official Title
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Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study

Conditions
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Cataract

Intervention / Treatment
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* Device: Square edge PMMA IOL
* Device: Round edge PMMA IOL
* Device: Acrysof IOL
* Device: square Edge PMMA IOL
* Device: Square Edge PMMA IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 to 65 years Bilateral senile cataract Pupil should be at least 7mm dilated Nuclear sclerosis grade I, II and III Patient willing for second eye surgery within 3 months Exclusion Criteria: Debilitated old patients Cardiac and serious illness Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear Inherent zonular weakness Glaucoma patients Relative afferent papillary defect (RAPD) Shallow anterior chamber Pseudoexfoliation Traumatic cataract Uveitis and complicated cataract One eyed patients Corneal pathology Post segment pathology including diabetic retinopathy Dense Posterior subcapsular cataract (PSCC) and Posterior polar cataract (PPC) High myopic and hyperopic patient

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 A - Square edge PMMA IOL<br>50 patientes will recieve square edge PMMA IOL | Device: Square edge PMMA IOL<br>* Arm 1 A - Square edge PMMA IOL<br>* Other names: S3602SQ;Device: square Edge PMMA IOL<br>* Square edge PMMA intra ocular lens<br>|
| Active Comparator: 1B<br>In group 1, 50 eyes will receive round edge PMMA IOL | Device: Round edge PMMA IOL<br>* Round edge PMMA IOL<br>* Other names: S3602;|
| Experimental: 2A<br>In group 2, 50 eyes will receive square edge PMMA IOL | Device: Square Edge PMMA IOL<br>* Square Edge PMMA IOL lens<br>|
| Active Comparator: 2B<br>In group 2, 50 eyes will receive acrysof IOL | Device: Acrysof IOL<br>* Acrysof IOL<br>* Other names: SA60AT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCO |  | 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double-Blind Method, Clinical Trials, Randomized, Lenses, Intraocular, Prospective Studies, PMMA, Visual acuity