Back to resultsEyelash Line Resection for Entropion Associated With Down's Syndrome
Primary Purpose
Down's Syndrome
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Eyelash line resection
Sponsored by
About this trial
This is an interventional treatment trial for Down's Syndrome focused on measuring Down's syndrome, entropion, lid plasty
Eligibility Criteria
Inclusion Criteria:
- The patients with entropion with Down's syndrome
Exclusion Criteria:
- The patients of Down's syndrome who do not have entropion.
Sites / Locations
- Kyorin Eye Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Entropion with Down's syndrome
Arm Description
Eyelash resection surgery was performed for entropion with Down's syndrome
Outcomes
Primary Outcome Measures
Grading scale of superficial punctate keratopathy
The degree of superficial punctate keratopathy was assessed by the area and density classification which was scored with the area of superficial punctate keratopathy graded from A0 through A3, and the density graded from D0 through D3.
Secondary Outcome Measures
Score of wearing glasses
The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01758718
Brief Title
Eyelash Line Resection for Entropion Associated With Down's Syndrome
Official Title
Eyelash Line Resection for Entropion Associated With Down's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyorin University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down's Syndrome
Keywords
Down's syndrome, entropion, lid plasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Entropion with Down's syndrome
Arm Type
Active Comparator
Arm Description
Eyelash resection surgery was performed for entropion with Down's syndrome
Intervention Type
Procedure
Intervention Name(s)
Eyelash line resection
Other Intervention Name(s)
Lid plastic surgery
Intervention Description
Eyelash resection surgery was performed for entropion with Down's syndrome
Primary Outcome Measure Information:
Title
Grading scale of superficial punctate keratopathy
Description
The degree of superficial punctate keratopathy was assessed by the area and density classification which was scored with the area of superficial punctate keratopathy graded from A0 through A3, and the density graded from D0 through D3.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Score of wearing glasses
Description
The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.
Time Frame
one ear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with entropion with Down's syndrome
Exclusion Criteria:
The patients of Down's syndrome who do not have entropion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akito Hirakata, MD
Organizational Affiliation
Kyorin Eye Center
Official's Role
Study Chair
Facility Information:
Facility Name
Kyorin Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24831720
Citation
Suzuki Y, Hama Y, Yoshikawa-Kobayashi I, Tomita K, Inoue M, Hirakata A. Eyelash line resection for cilial entropion in patients with Down's syndrome. Br J Ophthalmol. 2014 Oct;98(10):1442-7. doi: 10.1136/bjophthalmol-2014-304946. Epub 2014 May 15.
Results Reference
derived
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Eyelash Line Resection for Entropion Associated With Down's Syndrome
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