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

Phase 4

Completed

• Conditions: Posterior Capsule Opacification
• Interventions: Procedure: Phacoemulsification

• Registration Number: NCT01125345
• Lead Sponsor: Iladevi Cataract and IOL Research Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrophobic IOL	Phacoemulsification	The single piece Acrysof hydrophobic IOL model- SN60WF
Hydrophilic IOL	Phacoemulsification	Rayner Intraocular Lenses Ltd., England, Model C-flex 570C
Hydrophillic IOL	Phacoemulsification	Bausch and Lomb ltd, model Akreos Adapt

Primary Outcome Measures

Name	Time	Method
posterior capsule evaluation	3 years

Secondary Outcome Measures

Name	Time	Method
ND-Yag capsulotomy rate	3 years

Trial Locations

Locations (1)

Raghudeep Eye Clinic; 🇮🇳 Ahmedabad, Gujarat, India