Posterior Capsule Opacification Study
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 7, 2006
CompletedFirst Posted
Study publicly available on registry
April 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 12, 2012
July 1, 2012
5.3 years
April 7, 2006
July 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCO
1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Secondary Outcomes (1)
Visual Acuity
1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Study Arms (4)
Arm 1 A - Square edge PMMA IOL
EXPERIMENTAL50 patientes will recieve square edge PMMA IOL
1B
ACTIVE COMPARATORIn group 1, 50 eyes will receive round edge PMMA IOL
2A
EXPERIMENTALIn group 2, 50 eyes will receive square edge PMMA IOL
2B
ACTIVE COMPARATORIn group 2, 50 eyes will receive acrysof IOL
Interventions
Arm 1 A - Square edge PMMA IOL
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aurolablead
Study Sites (1)
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haripriya Aravind, MBBS, MS
Aravind Eye Hospital, Madurai
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2006
First Posted
April 10, 2006
Study Start
April 1, 2006
Primary Completion
July 1, 2011
Study Completion
January 1, 2012
Last Updated
July 12, 2012
Record last verified: 2012-07