Clinical Evaluation of Toric Intraocular Lens Made by Aur... | NCT01396616

Studies
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

NCT01396616

Sponsor

Aurolab

Status

Unknown status

Last Update Posted

Jan 8, 2013Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Astigmatism

Interventions

Experimental - Toric Intraocular lenses

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

May 2013Estimated

Completion Date

Jun 2013Estimated

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

Jan 7, 2013

Last Update Posted Date

Jan 8, 2013Estimated

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 purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.

Detailed Description

Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.

Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	The enrolled subject will be implanted with Toric IOL manufactured by AuroLab	Device: Experimental - Toric Intraocular lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental - Toric Intraocular lenses	Device	Toric Intraocular Lenses will be implenated with cataract patients having astigmatism	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vision improvement	The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively	150 days

Secondary Outcomes

Measure	Description	Time Frame
Refractive error correction	To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively	150 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 40 to 65
Senile cataract
Posterior Sub Capsular Cataract (PSCC)
Astigmatism 1.25 D or more
Residence within 100 kms of Madurai

Exclusion Criteria:

Traumatic & Complicated cataract
Poor mydriasis
Amblyopia
Severe Pseudo exfoliation (PXF)
Dense posterior polar cataract (PPC)
One eyed patients
Uveitis
Corneal pathology / Scar
Retinal Pathology contributing to visual loss
Intraoperative complication like PC rupture, Zonular dialysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Haripriya Aravind, MBBS., MS.,	Contact	+91 452 4356100	161	haripriya@aravind.org
Mr. Mohamed Hussain, M.Pharm	Contact	+91 452 4356100	364	clinicalresearch@aravind.org

Overall Officials

Name	Affiliation	Role
Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,	HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli	Principal Investigator

Locations

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

Type	Date	Date Unknown
Release	Jul 24, 2014
Reset	Aug 13, 2014

Submission Tracking

Estimated Results First Submitted Date

Jul 24, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 24, 2014			Aug 13, 2014

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided