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Clinical Trials/NCT01396629
NCT01396629
Completed
Not Applicable

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

Aurolab1 site in 1 country99 target enrollmentJuly 2011
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ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Aurolab
Enrollment
99
Locations
1
Primary Endpoint
intra operative complication
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
October 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aurolab
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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