- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650688
Difference in Grades of Epiblepharon According to Positional Changes and General Anesthesia
Epiblepharon is a very common condition among Asian children and is a fold of the skin and underlying pretarsal orbicularis muscle that overlaps the eyelid margin and pushes the lashes against the cornea. It is manifested by the anterior lamella overriding the posterior lamella which causes the lashes to brush against the cornea. Although the prevalence of epiblepharon is known to be high among Asians, its cause remains controversial. Several etiological factors may be involved in the pathogenesis of epiblepharon.
Although epiblepharon in the lower lids lessens and disappears with age in many cases, surgery must be performed at an early age in severe cases in order to prevent ocular trauma as the vertically oriented cilia of the lashes can erode the corneal epithelium. Induced keratitis and astigmatism are indications for surgical intervention.
Over our many years of surgical experience, the investigators came to realize that the severity of epiblepharon was reduced when patients were under general anesthesia during surgery. The purpose of this study was to investigate the role of the orbicularis muscle in the pathogenesis of lower lid epiblepharon and to analyze the differences in the severity of epiblepharon in the upright versus the supine position and before and after the induction of general anesthesia.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 120-752
- Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- subjects younger than 12 years
- more than 12 months' follow-up
- subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms
- subjects who underwent general anesthesia for surgical correction of epiblepharon
Exclusion Criteria:
- subjects older than 12 years
- less than 12 months' follow-up -. subjects who underwent surgery on local anesthesia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Epiblepharon
subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Degree of skin fold height
Time Frame: 1 hour before epiblepharon surgery
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1 hour before epiblepharon surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4-2012-0315
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