NCT02040129

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

Same day

First QC Date

January 16, 2014

Last Update Submit

January 16, 2014

Conditions

Congenital Cataract

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Change from baseline in quality of vision after cataract surgery at 24 months.

    preop, 3,6,12,24 months postop

Study Arms (1)

Acrysof toric IOL

EXPERIMENTAL

Acrysof Toric intraocular lens in congenital cataract

Device: Acrysof Toric IOL

Interventions

Acrysof Toric IOLDEVICE

Lens implantation following cataract surgery

Acrysof toric IOL

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bo Young Chun, M.D.

Daegu, Kyungsangpookdo, 700-721, South Korea

Location

Study Officials

  • Bo Young Chun, M.D

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Ophthalmology, School of medicine, Kyungpook National University

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

January 1, 2009

Primary Completion

January 1, 2009

Study Completion

November 1, 2009

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

KR(1)