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

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ClinicalTrials.gov Identifier: NCT01396629
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : November 16, 2012
Sponsor:
Information provided by (Responsible Party):
Aurolab

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.

Condition or disease Intervention/treatment
Cataract Procedure: cartridge

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.

Study Type : Observational
Actual Enrollment : 99 participants
Time Perspective: Prospective
Official Title: Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
Study Start Date : July 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Group/Cohort Intervention/treatment
single group
the intra ocular lenses will be loaded in the cartridge.
Procedure: cartridge
IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery



Primary Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between 40-60
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396629


Locations
India
Aravind Eye Hospital
Madurai, Tamilnadu, India, 625020
Sponsors and Collaborators
Aurolab
Investigators
Principal Investigator: Dr. Haripriya Aravind, MBBS., MS., HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01396629     History of Changes
Other Study ID Numbers: 8PN1011155
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012

Keywords provided by Aurolab:
cartridge IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases