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

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

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.

Study Overview

• Status: Completed
• Conditions: Posterior Capsule Opacification
• Intervention / Treatment: Procedure: Phacoemulsification

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380013
      • Raghudeep Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
posterior capsule evaluation	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
ND-Yag capsulotomy rate	3 years

Collaborators and Investigators

• Sponsor: Iladevi Cataract and IOL Research Center
• Investigators: Principal Investigator: Abhay Vasavada, MD, Iladevi Cataract and IOL Research Center

Publications and helpful links

General Publications

• Johansson B. Clinical consequences of acrylic intraocular lens material and design: Nd:YAG-laser capsulotomy rates in 3 x 300 eyes 5 years after phacoemulsification. Br J Ophthalmol. 2010 Apr;94(4):450-5. doi: 10.1136/bjo.2009.166181. Epub 2009 Oct 14.
• Lombardo M, Carbone G, Lombardo G, De Santo MP, Barberi R. Analysis of intraocular lens surface adhesiveness by atomic force microscopy. J Cataract Refract Surg. 2009 Jul;35(7):1266-72. doi: 10.1016/j.jcrs.2009.02.029.
• Kugelberg M, Wejde G, Jayaram H, Zetterstrom C. Two-year follow-up of posterior capsule opacification after implantation of a hydrophilic or hydrophobic acrylic intraocular lens. Acta Ophthalmol. 2008 Aug;86(5):533-6. doi: 10.1111/j.1600-0420.2007.01094.x. Epub 2007 Dec 11.
• Kugelberg M, Wejde G, Jayaram H, Zetterstrom C. Posterior capsule opacification after implantation of a hydrophilic or a hydrophobic acrylic intraocular lens: one-year follow-up. J Cataract Refract Surg. 2006 Oct;32(10):1627-31. doi: 10.1016/j.jcrs.2006.05.011.
• Heatley CJ, Spalton DJ, Kumar A, Jose R, Boyce J, Bender LE. Comparison of posterior capsule opacification rates between hydrophilic and hydrophobic single-piece acrylic intraocular lenses. J Cataract Refract Surg. 2005 Apr;31(4):718-24. doi: 10.1016/j.jcrs.2004.08.060.
• Werner L, Mamalis N, Pandey SK, Izak AM, Nilson CD, Davis BL, Weight C, Apple DJ. Posterior capsule opacification in rabbit eyes implanted with hydrophilic acrylic intraocular lenses with enhanced square edge. J Cataract Refract Surg. 2004 Nov;30(11):2403-9. doi: 10.1016/j.jcrs.2004.02.085.
• Nishi Y, Rabsilber TM, Limberger IJ, Reuland AJ, Auffarth GU. Influence of 360-degree enhanced optic edge design of a hydrophilic acrylic intraocular lens on posterior capsule opacification. J Cataract Refract Surg. 2007 Feb;33(2):227-31. doi: 10.1016/j.jcrs.2006.10.020.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: PCO; posterior capsule opacification; hydrophobic acrylic; hydrophilic acrylic IO
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: 06-009