Posterior Capsule Opacification Study

July 11, 2012 updated by: Aurolab

Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study

First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)

The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)

100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Aravind Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40 to 65 years
  • Bilateral senile cataract
  • Pupil should be at least 7mm dilated
  • Nuclear sclerosis grade I, II and III
  • Patient willing for second eye surgery within 3 months

Exclusion Criteria:

  • Debilitated old patients
  • Cardiac and serious illness
  • Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear
  • Inherent zonular weakness
  • Glaucoma patients
  • Relative afferent papillary defect (RAPD)
  • Shallow anterior chamber
  • Pseudoexfoliation
  • Traumatic cataract
  • Uveitis and complicated cataract
  • One eyed patients
  • Corneal pathology
  • Post segment pathology including diabetic retinopathy
  • Dense Posterior subcapsular cataract (PSCC) and Posterior polar cataract (PPC)
  • High myopic and hyperopic patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 A - Square edge PMMA IOL
50 patientes will recieve square edge PMMA IOL
Device: Square edge PMMA IOL
Arm 1 A - Square edge PMMA IOL
Other Names:
  • TrueEdge IOL
  • S3602SQ
Active Comparator: 1B
In group 1, 50 eyes will receive round edge PMMA IOL
Device: Round edge PMMA IOL
Round edge PMMA IOL
Other Names:
  • S3602
Experimental: 2A
In group 2, 50 eyes will receive square edge PMMA IOL
Device: Square Edge PMMA IOL
Square Edge PMMA IOL lens
Active Comparator: 2B
In group 2, 50 eyes will receive acrysof IOL
Device: Acrysof IOL
Acrysof IOL
Other Names:
  • SA60AT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCO
Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Investigators

  • Principal Investigator: Haripriya Aravind, MBBS, MS, Aravind Eye Hospital, Madurai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 7, 2006

First Submitted That Met QC Criteria

April 7, 2006

First Posted (Estimate)

April 10, 2006

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2PR1210608

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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