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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01396629
First received: July 14, 2011
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Cataract
Procedure: cartridge

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses

Resource links provided by NLM:


Further study details as provided by Aurolab:

Primary Outcome Measures:
  • intra operative complication [ Time Frame: post operative day 1 ] [ Designated as safety issue: Yes ]
    to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1


Enrollment: 99
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01396629     History of Changes
Other Study ID Numbers: 8PN1011155
Study First Received: July 14, 2011
Last Updated: November 15, 2012
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
cartridge IOL

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014