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NCT01396629 Clinical Trial

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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01396629
Other study ID # 8PN1011155
Secondary ID
Status Completed
Phase N/A
First received July 14, 2011
Last updated November 15, 2012
Start date July 2011
Est. completion date October 2012

Study information
Verified date November 2012
Source Aurolab
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 60 Years
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
India Aravind Eye Hospital Madurai Tamilnadu

Sponsors (1)
Lead Sponsor Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary intra operative complication to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1 post operative day 1 Yes
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