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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312299

Enrollment

100

Registered

2006-04-10

Start date

2006-04-30

Completion date

2012-01-31

Last updated

2012-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Double-Blind Method, Clinical Trials, Randomized, Lenses, Intraocular, Prospective Studies, PMMA, Visual acuity

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.

Interventions

DEVICESquare edge PMMA IOL

Arm 1 A - Square edge PMMA IOL

DEVICERound edge PMMA IOL

Round edge PMMA IOL

DEVICEAcrysof IOL

Acrysof IOL

DEVICEsquare Edge PMMA IOL

Square edge PMMA intra ocular lens

DEVICESquare Edge PMMA IOL

Square Edge PMMA IOL lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
PCO	1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Secondary

Measure	Time frame
Visual Acuity	1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026