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

NCT ID: NCT01396629

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Cataract

Keywords

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cartridge IOL

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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single group

the intra ocular lenses will be loaded in the cartridge.

cartridge

Intervention Type PROCEDURE

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

Interventions

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cartridge

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Haripriya Aravind, MBBS., MS.,

Role: PRINCIPAL_INVESTIGATOR

HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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8PN1011155

Identifier Type: -

Identifier Source: org_study_id