Clinical Evaluation of a New Cartridge for the Implantati... | NCT01396629

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

NCT01396629

Sponsor

Aurolab

Status

Completed

Last Update Posted

Nov 16, 2012Estimated

Enrollment

99Actual

Phase

Not provided

Conditions

Cataract

Interventions

cartridge

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 17, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2012

Last Update Posted Date

Nov 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single group		the intra ocular lenses will be loaded in the cartridge.	Procedure: cartridge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cartridge	Procedure	IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery	single group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Haripriya Aravind, MBBS., MS.,	HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aravind Eye Hospital		Madurai	Tamil Nadu	625020	India

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided