Back to resultsReduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
Primary Purpose
Congenital Cataract
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acrysof Toric IOL
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Cataract
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
Sites / Locations
- Bo Young Chun, M.D.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acrysof toric IOL
Arm Description
Acrysof Toric intraocular lens in congenital cataract
Outcomes
Primary Outcome Measures
Change from baseline in astigmatism after cataract surgery at 24 months
Measurement of refraction after cataract surgery was performed.
Secondary Outcome Measures
Change from baseline in quality of vision after cataract surgery at 24 months.
Measurement of visual acuity after cataract surgery was performed.
Full Information
NCT ID
NCT02040129
First Posted
January 16, 2014
Last Updated
January 16, 2014
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02040129
Brief Title
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
Official Title
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acrysof toric IOL
Arm Type
Experimental
Arm Description
Acrysof Toric intraocular lens in congenital cataract
Intervention Type
Device
Intervention Name(s)
Acrysof Toric IOL
Intervention Description
Lens implantation following cataract surgery
Primary Outcome Measure Information:
Title
Change from baseline in astigmatism after cataract surgery at 24 months
Description
Measurement of refraction after cataract surgery was performed.
Time Frame
preop, 3,6,12,24 month postop
Secondary Outcome Measure Information:
Title
Change from baseline in quality of vision after cataract surgery at 24 months.
Description
Measurement of visual acuity after cataract surgery was performed.
Time Frame
preop, 3,6,12,24 months postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Young Chun, M.D
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bo Young Chun, M.D.
City
Daegu
State/Province
Kyungsangpookdo
ZIP/Postal Code
700-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
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