- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02040129
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
January 16, 2014 updated by: Bo Young Chun, Kyungpook National University Hospital
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract
This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kyungsangpookdo
-
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
- Bo Young Chun, M.D.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acrysof toric IOL
Acrysof Toric intraocular lens in congenital cataract
|
Lens implantation following cataract surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in astigmatism after cataract surgery at 24 months
Time Frame: preop, 3,6,12,24 month postop
|
Measurement of refraction after cataract surgery was performed.
|
preop, 3,6,12,24 month postop
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in quality of vision after cataract surgery at 24 months.
Time Frame: preop, 3,6,12,24 months postop
|
Measurement of visual acuity after cataract surgery was performed.
|
preop, 3,6,12,24 months postop
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bo Young Chun, M.D, Kyungpook National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
January 16, 2014
First Submitted That Met QC Criteria
January 16, 2014
First Posted (Estimate)
January 20, 2014
Study Record Updates
Last Update Posted (Estimate)
January 20, 2014
Last Update Submitted That Met QC Criteria
January 16, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNUH2014-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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