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Completed

NCT Number: NCT00312299

Posterior Capsule Opacification Study

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

Completed

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Square edge PMMA IOL

Device

Arm 1 A - Square edge PMMA IOL

Other names: TrueEdge IOL, S3602SQ

Round edge PMMA IOL

Device

Round edge PMMA IOL

Other names: S3602

Acrysof IOL

Device

Acrysof IOL

Other names: SA60AT

Primary outcomes

  1. PCO

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

Secondary outcomes

  1. Visual Acuity

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

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Apr 10, 2006
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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