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

NCT ID: NCT01125345

Last Updated: 2010-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Posterior Capsule Opacification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hydrophobic IOL

The single piece Acrysof hydrophobic IOL model- SN60WF

Group Type: EXPERIMENTAL

Phacoemulsification

Intervention Type: PROCEDURE

Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery

Hydrophilic IOL

Rayner Intraocular Lenses Ltd., England, Model C-flex 570C

Group Type: ACTIVE_COMPARATOR

Phacoemulsification

Intervention Type: PROCEDURE

Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery

Hydrophillic IOL

Bausch and Lomb ltd, model Akreos Adapt

Group Type: ACTIVE_COMPARATOR

Phacoemulsification

Intervention Type: PROCEDURE

Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery

Interventions

Phacoemulsification

Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role: lead

Responsible Party

Raghudeep Eye Clinic

Principal Investigators

Abhay Vasavada, MD

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract and IOL Research Center

Locations

Raghudeep Eye Clinic

Ahmedabad, Gujarat, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 19828518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19545819 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18081899 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17010858 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15899448 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15519096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17276262 (View on PubMed)

Other Identifiers

06-009

Identifier Type: -

Identifier Source: org_study_id