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

November 15, 2012 updated by: Aurolab
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Madurai, Tamilnadu, India, 625020
        • Aravind Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between 40-60

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Investigators

  • Principal Investigator: Dr. Haripriya Aravind, MBBS., MS.,, HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 17, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8PN1011155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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