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

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01125345
First received: May 17, 2010
Last updated: June 3, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Posterior Capsule Opacification
Procedure: Phacoemulsification
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • posterior capsule evaluation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ND-Yag capsulotomy rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125345

Locations
India
Raghudeep Eye Clinic
Ahmedabad, Gujarat, India, 380013
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Abhay Vasavada, MD Iladevi Cataract and IOL Research Center
  More Information

Publications:

Responsible Party: Dr. Shetal M. Raj, Raghudeep Eye Clinic
ClinicalTrials.gov Identifier: NCT01125345     History of Changes
Other Study ID Numbers: 06-009
Study First Received: May 17, 2010
Last Updated: June 3, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:
hydrophobic acrylic
PCO
posterior capsule opacification
hydrophilic acrylic IO

Additional relevant MeSH terms:
Capsule Opacification
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014