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Posterior Capsule Opacification Study

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Square edge PMMA IOL
Round edge PMMA IOL
Acrysof IOL
square Edge PMMA IOL
Square Edge PMMA IOL
Sponsored by
Aurolab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Double-Blind Method, Clinical Trials, Randomized, Lenses, Intraocular, Prospective Studies, PMMA, Visual acuity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aravind Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Arm 1 A - Square edge PMMA IOL

1B

2A

2B

Arm Description

50 patientes will recieve square edge PMMA IOL

In group 1, 50 eyes will receive round edge PMMA IOL

In group 2, 50 eyes will receive square edge PMMA IOL

In group 2, 50 eyes will receive acrysof IOL

Outcomes

Primary Outcome Measures

PCO

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
April 7, 2006
Last Updated
July 11, 2012
Sponsor
Aurolab
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1. Study Identification

Unique Protocol Identification Number
NCT00312299
Brief Title
Posterior Capsule Opacification Study
Official Title
Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurolab

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Double-Blind Method, Clinical Trials, Randomized, Lenses, Intraocular, Prospective Studies, PMMA, Visual acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 A - Square edge PMMA IOL
Arm Type
Experimental
Arm Description
50 patientes will recieve square edge PMMA IOL
Arm Title
1B
Arm Type
Active Comparator
Arm Description
In group 1, 50 eyes will receive round edge PMMA IOL
Arm Title
2A
Arm Type
Experimental
Arm Description
In group 2, 50 eyes will receive square edge PMMA IOL
Arm Title
2B
Arm Type
Active Comparator
Arm Description
In group 2, 50 eyes will receive acrysof IOL
Intervention Type
Device
Intervention Name(s)
Square edge PMMA IOL
Other Intervention Name(s)
TrueEdge IOL, S3602SQ
Intervention Description
Arm 1 A - Square edge PMMA IOL
Intervention Type
Device
Intervention Name(s)
Round edge PMMA IOL
Other Intervention Name(s)
S3602
Intervention Description
Round edge PMMA IOL
Intervention Type
Device
Intervention Name(s)
Acrysof IOL
Other Intervention Name(s)
SA60AT
Intervention Description
Acrysof IOL
Intervention Type
Device
Intervention Name(s)
square Edge PMMA IOL
Intervention Description
Square edge PMMA intra ocular lens
Intervention Type
Device
Intervention Name(s)
Square Edge PMMA IOL
Intervention Description
Square Edge PMMA IOL lens
Primary Outcome Measure Information:
Title
PCO
Time Frame
1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haripriya Aravind, MBBS, MS
Organizational Affiliation
Aravind Eye Hospital, Madurai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India

12. IPD Sharing Statement

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Posterior Capsule Opacification Study

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