Posterior Capsule Opacification Study

Cataract Clinical Trial

Official title:

Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312299
• Other study ID #: 2PR1210608
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2006
• Last updated: July 11, 2012
• Start date: April 2006
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Intervention

Device:
• Square edge PMMA IOL
Arm 1 A - Square edge PMMA IOL
• Round edge PMMA IOL
Round edge PMMA IOL
• Acrysof IOL
Acrysof IOL
• square Edge PMMA IOL
Square edge PMMA intra ocular lens
• Square Edge PMMA IOL
Square Edge PMMA IOL lens

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCO		1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year	No
Secondary	Visual Acuity		1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year	No