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Posterior Capsule Opacification Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT00312299
First received: April 7, 2006
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cataract
 Device: Square edge PMMA IOL
Device: Round edge PMMA IOL
Device: Acrysof IOL
Device: square Edge PMMA IOL
Device: Square Edge PMMA IOL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • PCO [ Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2006
Study Completion Date: January 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: square Edge PMMA IOL
Square edge PMMA intra ocular lens
Active Comparator: 1B
In group 1, 50 eyes will receive round edge PMMA IOL
 Device: Round edge PMMA IOL
Round edge PMMA IOL
Other Name: 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 Name: SA60AT

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312299

Locations
India
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020
Sponsors and Collaborators
Aurolab
Investigators
Principal Investigator: Haripriya Aravind, MBBS, MS Aravind Eye Hospital, Madurai
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT00312299     History of Changes
Other Study ID Numbers: 2PR1210608
Study First Received: April 7, 2006
Last Updated: July 11, 2012
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
Double-Blind Method
Clinical Trials, Randomized
Lenses, Intraocular
 Prospective Studies
PMMA
Visual acuity

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

ClinicalTrials.gov processed this record on May 19, 2013