Difference in Grades of Epiblepharon According to Positional Changes and General Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Yonsei University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01650688
First received: July 15, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition
Epiblepharon

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Degree of skin fold height [ Time Frame: 1 hour before epiblepharon surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: July 2012
Estimated Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epiblepharon
subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms

  Eligibility

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with epiblepharon which needed surgical correction

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01650688

Locations
Korea, Republic of
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01650688     History of Changes
Other Study ID Numbers: 4-2012-0315
Study First Received: July 15, 2012
Last Updated: July 23, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
Epiblepharon, general anesthesia, positional change

ClinicalTrials.gov processed this record on October 20, 2014