Eyelash Line Resection for Entropion Associated With Down's Syndrome

Down's Syndrome Clinical Trial

Official title:

Eyelash Line Resection for Entropion Associated With Down's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758718
• Other study ID #: Kyorineye009
• Secondary ID: Entropion with D
• Status: Completed
• Phase: N/A
• First received: December 27, 2012
• Last updated: December 27, 2012
• Start date: April 2007
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 90 Years

Eligibility

Inclusion Criteria:

• The patients with entropion with Down's syndrome

Exclusion Criteria:

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Down Syndrome
• Down's Syndrome
• Entropion
• Syndrome

Intervention

Procedure:
• Eyelash line resection
Eyelash resection surgery was performed for entropion with Down's syndrome

Locations

Country	Name	City	State
Japan	Kyorin Eye Center	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	Score of wearing glasses	The score of wearing glasses was graded 2; all day, 1; more than half day, 0; none of the day.	one ear	No