NCT01125345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
Last Updated

June 4, 2010

Status Verified

May 1, 2010

Enrollment Period

3.9 years

First QC Date

May 17, 2010

Last Update Submit

June 3, 2010

Conditions

Posterior Capsule Opacification

Keywords

hydrophobic acrylicPCOposterior capsule opacificationhydrophilic acrylic IO

Outcome Measures

Primary Outcomes (1)

  • posterior capsule evaluation

    3 years

Secondary Outcomes (1)

  • ND-Yag capsulotomy rate

    3 years

Study Arms (3)

Hydrophobic IOL

EXPERIMENTAL

The single piece Acrysof hydrophobic IOL model- SN60WF

Procedure: Phacoemulsification

Hydrophilic IOL

ACTIVE COMPARATOR

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

Procedure: Phacoemulsification

Hydrophillic IOL

ACTIVE COMPARATOR

Bausch and Lomb ltd, model Akreos Adapt

Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery

Hydrophilic IOLHydrophillic IOLHydrophobic IOL

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • coexisting ocular morbidities
  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raghudeep Eye Clinic

Ahmedabad, Gujarat, 380013, India

Location

Related Publications (7)

  • 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.

    PMID: 19828518BACKGROUND

  • 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.

    PMID: 19545819BACKGROUND

  • 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.

    PMID: 18081899BACKGROUND

  • 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.

    PMID: 17010858BACKGROUND

  • 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.

    PMID: 15899448BACKGROUND

  • 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.

    PMID: 15519096BACKGROUND

  • 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.

    PMID: 17276262BACKGROUND

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Abhay Vasavada, MD

    Iladevi Cataract and IOL Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 4, 2010

Record last verified: 2010-05

Locations

IN(1)