NCT00312299

Posterior Capsule Opacification Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aurolab · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Square edge PMMA IOL	Arm 1 A - Square edge PMMA IOL
DEVICE	Round edge PMMA IOL	Round edge PMMA IOL
DEVICE	Acrysof IOL	Acrysof IOL
DEVICE	square Edge PMMA IOL	Square edge PMMA intra ocular lens
DEVICE	Square Edge PMMA IOL	Square Edge PMMA IOL lens

Timeline

• Start date: 2006-04-01
• Primary completion: 2011-07-01
• Completion: 2012-01-01
• First posted: 2006-04-10
• Last updated: 2012-07-12

Locations

1 site across 1 country: India