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Eyelash Line Resection for Entropion Associated With Down's Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01758718
First received: December 27, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Down's Syndrome
 Procedure: Eyelash line resection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eyelash Line Resection for Entropion Associated With Down's Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • Grading scale of superficial punctate keratopathy [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one ear ] [ Designated as safety issue: No ]
    The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.


Enrollment: 24
Study Start Date: April 2007
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entropion with Down's syndrome
Eyelash resection surgery was performed for entropion with Down's syndrome
 Procedure: Eyelash line resection
Eyelash resection surgery was performed for entropion with Down's syndrome
Other Name: Lid plastic surgery

  Eligibility

Ages Eligible for Study:   3 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients with entropion with Down's syndrome

Exclusion Criteria:

  • The patients of Down's syndrome who do not have entropion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758718

Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Study Chair: Akito Hirakata, MD Kyorin Eye Center
  More Information

No publications provided

Responsible Party: Makoto Inoue, Associate professor of Ophthalmology, Kyorin University
ClinicalTrials.gov Identifier: NCT01758718     History of Changes
Other Study ID Numbers: Kyorineye009, Entropion with Down's syndrome
Study First Received: December 27, 2012
Last Updated: December 27, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
Down's syndrome
entropion
lid plasty

Additional relevant MeSH terms:
Down Syndrome
Entropion
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013