Posterior Capsule Opacification (PCO) With Single Piece Hydrophobic Versus Hydrophillic Intraocular Lens (IOL)

Study Overview
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Brief Summary
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The purpose of the study was to compare the postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.

Detailed Description
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Amongst several surgical techniques and IOL technology that influence the opacification of the posterior capsule, the role of IOL material and optic design remain crucial in determining its development. The single-piece Acrylic IOLs with a hydrophobic surface have been widely used in practice. The single-piece Acrylic IOLs with a hydrophilic surface became commercially available more recently. Although there is a study that compared the single piece hydrophobic and the single piece hydrophilic IOL, it was conducted on the older generation of the hydrophilic IOL. Moreover, experimental and clinical study has been performed to evaluate the posterior capsule opacification between the Hydrophilic acrylic IOL with a sharp optic edge design excluding the optic-haptic junction, versus the newer generation hydrophilic IOL design which has an improved 360-degree sharp edge, with results favouring the latter design. There is little data that compares the single-piece Acrylic IOLs with a hydrophobic surface to the newer generation single-piece Acrylic IOLs with a hydrophilic surface. Because the IOL characteristics play a crucial role to prevent posterior capsule opacification (PCO), it is of clinical importance, as well as investigational interest to assess the PCO following implantation of these IOLs. We conducted a prospective, randomised, intra-individual study to compare the 3 year postoperative PCO results of the single-piece hydrophobic Acrylic IOLs versus the newer generation single-piece hydrophilic Acrylic IOLs in patients undergoing bilateral cataract surgery.

Official Title
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A Prospective Controlled Clinical Trial to Evaluate the Posterior Capsule Opacification in Contralateral Eyes Implanted With Single Piece Hydrophobic AcrySof IOL and Single Piece Hydrophilic Acrylic IOLs

Conditions
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Posterior Capsule Opacification

Intervention / Treatment
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* Procedure: Phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral senile surgery age ranged from 53 to 78 years pupil mydriasis > 7 mm No history of previous ocular surgery gave consent for followup examination Exclusion Criteria: coexisting ocular morbidities diabetes mellitus

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrophobic IOL<br>The single piece Acrysof hydrophobic IOL model- SN60WF | Procedure: Phacoemulsification<br>* Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery<br>|
| Active Comparator: Hydrophilic IOL<br>Rayner Intraocular Lenses Ltd., England, Model C-flex 570C | Procedure: Phacoemulsification<br>* Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery<br>|
| Active Comparator: Hydrophillic IOL<br>Bausch and Lomb ltd, model Akreos Adapt | Procedure: Phacoemulsification<br>* Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| posterior capsule evaluation |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ND-Yag capsulotomy rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrophobic acrylic, PCO, posterior capsule opacification, hydrophilic acrylic IO