NCT01758718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

January 1, 2013

Status Verified

December 1, 2012

Enrollment Period

4.9 years

First QC Date

December 27, 2012

Last Update Submit

December 27, 2012

Conditions

Down's Syndrome

Keywords

Down's syndromeentropionlid plasty

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Score of wearing glasses

    one ear

Study Arms (1)

Entropion with Down's syndrome

ACTIVE COMPARATOR

Eyelash resection surgery was performed for entropion with Down's syndrome

Procedure: Eyelash line resection

Interventions

Eyelash line resectionPROCEDURE

Eyelash resection surgery was performed for entropion with Down's syndrome

Also known as: Lid plastic surgery
Entropion with Down's syndrome

Eligibility Criteria

Age3 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with entropion with Down's syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

Related Publications (1)

  • 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.

    PMID: 24831720DERIVED

MeSH Terms

Conditions

Down SyndromeEntropion

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornEyelid DiseasesEye Diseases

Study Officials

  • Akito Hirakata, MD

    Kyorin Eye Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

December 27, 2012

First Posted

January 1, 2013

Study Start

April 1, 2007

Primary Completion

March 1, 2012

Study Completion

October 1, 2012

Last Updated

January 1, 2013

Record last verified: 2012-12

Locations

JP(1)