Posterior Capsule Opacification Study

Aurolab

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Square edge PMMA IOL; Device: Square Edge PMMA IOL; Device: square Edge PMMA IOL; Device: Acrysof IOL; Device: Round edge PMMA IOL

Study type: Interventional

Funder types: Other

Identifiers

NCT00312299

2PR1210608

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Arm 1 A - Square edge PMMA IOL

Experimental group

Description:

50 patientes will recieve square edge PMMA IOL

Treatment:

Device: Square edge PMMA IOL

1B

Active Comparator group

Description:

In group 1, 50 eyes will receive round edge PMMA IOL

Treatment:

Device: Round edge PMMA IOL

2A

Experimental group

Description:

In group 2, 50 eyes will receive square edge PMMA IOL

Treatment:

Device: Square Edge PMMA IOL

2B

Active Comparator group

Description:

In group 2, 50 eyes will receive acrysof IOL

Treatment:

Device: Acrysof IOL