NCT02131792

Brief Summary

This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

May 4, 2014

Last Update Submit

May 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.

    Measurement of deviation angle after slanted recession surgery was performed.

    preop, 6months postop

Secondary Outcomes (1)

  • Changes from baseline of near-distance difference after slanted recession surgery at 6 months

    preop, 6 months postop

Study Arms (1)

Lateral Rectus Muscle Slanted Recession

EXPERIMENTAL

Slanted recession of the lateral rectus muscle for the intermittent exotropia with convergence weakness

Procedure: Slanted recession of the lateral rectus muscle

Interventions

All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.

Lateral Rectus Muscle Slanted Recession

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
  • Patients with follow up duration greater than 6 months

You may not qualify if:

  • Patients with previous ocular or strabismus surgery
  • Patients with ocular or neurologic pathologic conditions
  • Follow up duration less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bo Young Chun

Daegu, Kyungsangpookdo, 700-721, South Korea

Location

Study Officials

  • Bo Young Chun, M.D

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

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
Department of Ophthalmology, School of medicine, Kyungpook National University

Study Record Dates

First Submitted

May 4, 2014

First Posted

May 6, 2014

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

April 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations