Eyelash Line Resection for Entropion Associated With Down's Syndrome

December 27, 2012 updated by: Makoto Inoue, Kyorin University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Japan
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin Eye Center

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

3 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients with entropion with Down's syndrome

Exclusion Criteria:

  • The patients of Down's syndrome who do not have entropion.

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
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 Names:
  • Lid plastic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grading scale of superficial punctate keratopathy
Time Frame: one year
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of wearing glasses
Time Frame: one ear
The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.
one ear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin University

Investigators

  • Study Chair: Akito Hirakata, MD, Kyorin Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 27, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 1, 2013

Last Update Submitted That Met QC Criteria

December 27, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyorineye009
  • Entropion with Down's syndrome

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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