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

Posterior Capsule Opacification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125345
• Other study ID #: 06-009
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2010
• Last updated: June 3, 2010
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification

Intervention

Procedure:
• Phacoemulsification
Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery

Locations

Country	Name	City	State
India	Raghudeep Eye Clinic	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

References & Publications (7)

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. — View Citation

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. — View Citation

Kugelberg M, Wejde G, Jayaram H, Zetterström 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. — View Citation

Kugelberg M, Wejde G, Jayaram H, Zetterström 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. Epub 2007 Dec 11. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	posterior capsule evaluation		3 years	No
Secondary	ND-Yag capsulotomy rate		3 years	No