Reduction of Corneal Astigmatism With Toric Intraocular L... | NCT02040129

Studies
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract

NCT02040129

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Jan 20, 2014Estimated

Enrollment

4Actual

Phase

Not Applicable

Conditions

Congenital Cataract

Interventions

Acrysof Toric IOL

Countries

South Korea

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

Jan 2014

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

Jan 2009

Primary Completion Date

Jan 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Jan 16, 2014

First Posted Date

Jan 20, 2014Estimated

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 16, 2014

Last Update Posted Date

Jan 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bo Young Chun, Department of Ophthalmology, School of medicine, Kyungpook National University, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.

Detailed Description

This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acrysof toric IOL	Experimental	Acrysof Toric intraocular lens in congenital cataract	Device: Acrysof Toric IOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acrysof Toric IOL	Device	Lens implantation following cataract surgery	Acrysof toric IOL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in astigmatism after cataract surgery at 24 months	Measurement of refraction after cataract surgery was performed.	preop, 3,6,12,24 month postop

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in quality of vision after cataract surgery at 24 months.	Measurement of visual acuity after cataract surgery was performed.	preop, 3,6,12,24 months postop

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children less than 14 years
Congenital cataract at initial visit
Symmetrical keratometric astigmatism more than 2.0 D

Exclusion Criteria:

Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age)
Corneal pathology
Keratoconus
Irregular astigmatism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo Young Chun, M.D	Kyungpook National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bo Young Chun, M.D.		Daegu	Kyungsangpookdo	700-721	South Korea