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OpenTrials
Completed

NCT Number: NCT01396629

Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses

The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

About this study

Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 40 to 60
  • Senile cataract
  • Nuclear Sclerosis grade I and grade II

Exclusion criteria

  • Inherent zonular weakness
  • Shallow anterior chamber
  • PXF
  • Traumatic cataract
  • Uveitis and Complicated cataract
  • Dense PSCC and PPC

Treatment and study plan

cartridge

Procedure

IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery

Primary outcomes

  1. intra operative complication

    Time frame: post operative day 1

    to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2011
Registry last updated
Nov 16, 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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