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Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery

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: NCT02699580
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE February 22, 2016
First Posted Date  ICMJE March 4, 2016
Last Update Posted Date January 25, 2017
Actual Study Start Date  ICMJE September 30, 2015
Actual Primary Completion Date September 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
Scleral thinning assessed with slit photography [ Time Frame: Postoperative 3 months ]
Scleral thinning at the area, where lateral rectus was originally inserted, was assessed with slit photography. Scleral thinning score was calculated from the Lab color model.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • Ocular discharge assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Ocular discharge will be assessed by questionnaire.
  • Tearing assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Tearing will be assessed by questionnaire.
  • Foreign body sensation assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Foreign body sensation will be assessed by questionnaire.
  • Collagen implant protrusion assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Collagen implant protrusion will be assessed by questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
Official Title  ICMJE Not Provided
Brief Summary This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Exotropia or Intermittent Exotropia
Intervention  ICMJE
  • Device: lateral rectus recession with biodegradable collagen implant
    Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done. After lateral rectus recession, no degradable collagen implant was placed in the area, where lateral rectus was original inserted. One eye was randomly selected for the comparison.
  • Procedure: Lateral rectus recession without biodegradable collagen implantation
    Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation.
Study Arms  ICMJE
  • Experimental: Biodegradable collagen implant
    Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
    Intervention: Device: lateral rectus recession with biodegradable collagen implant
  • Active Comparator: Without biodegradable collagen implant
    Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.
    Intervention: Procedure: Lateral rectus recession without biodegradable collagen implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 10, 2016
Actual Primary Completion Date September 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with intermittent exotropia or constant exotropia
  2. Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
  3. Subjects who want to do strabismus surgery

Exclusion Criteria:

  1. Subject who had previous strabismus surgery or other ocular surgery history
  2. Thyroid eye disease or other connective tissue disease
  3. Significant bleeding or scleral perforation during operation
  4. Subjects who need to do medial rectus resection, not lateral rectus recession
  5. Subjects who had a plan to do other intra or extraocular surgery within 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02699580
Other Study ID Numbers  ICMJE 4-2015-0741
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share individual participant data
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP