Posterior Capsule Opacification Study

Sponsor

Aurolab (Other)

Overall Status

Completed

CT.gov ID

NCT00312299

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2006

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

PCO [1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year]

Secondary Outcome Measures

Visual Acuity [1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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