Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Aurolab
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- PCO
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
PCO
Time Frame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Secondary Outcomes
- Visual Acuity(1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year)