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

Completed

• Conditions: Cataract
• Interventions: Procedure: cartridge

• Registration Number: NCT01396629
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-17
• Study First Posted: 2011-07-19
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single group	cartridge	the intra ocular lenses will be loaded in the cartridge.

Primary Outcome Measures

Name	Time	Method
intra operative complication	post operative day 1	to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamilnadu, India