Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01650688
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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 or disease
Epiblepharon

Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Actual Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Group/Cohort
Epiblepharon
subjects demonstrating prominent corneal touch by cilia and/or related subjective symptoms



Primary Outcome Measures :
  1. Degree of skin fold height [ Time Frame: 1 hour before epiblepharon surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650688


Locations
Layout table for location information
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01650688    
Other Study ID Numbers: 4-2012-0315
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by Yonsei University:
Epiblepharon, general anesthesia, positional change