Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Posterior Capsule Opacification Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00312299
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
Aurolab

Brief Summary:
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 or disease Intervention/treatment 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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2006
Actual Primary Completion Date : July 2011
Actual Study Completion Date : January 2012

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

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




Primary Outcome Measures :
  1. PCO [ Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312299


Locations
Layout table for location information
India
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020
Sponsors and Collaborators
Aurolab
Investigators
Layout table for investigator information
Principal Investigator: Haripriya Aravind, MBBS, MS Aravind Eye Hospital, Madurai

Layout table for additonal information
Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT00312299     History of Changes
Other Study ID Numbers: 2PR1210608
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs