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

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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

Study Description
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Brief Summary:
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.

Condition or disease Intervention/treatment Phase
Exotropia or Intermittent Exotropia Device: lateral rectus recession with biodegradable collagen implant Procedure: Lateral rectus recession without biodegradable collagen implantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : September 10, 2016
Actual Study Completion Date : September 10, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: Biodegradable collagen implant
Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
 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.
Active Comparator: Without biodegradable collagen implant
Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ocular discharge assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Ocular discharge will be assessed by questionnaire.

  2. Tearing assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Tearing will be assessed by questionnaire.

  3. Foreign body sensation assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Foreign body sensation will be assessed by questionnaire.

  4. Collagen implant protrusion assessed by questionnaire [ Time Frame: Postoperative 1 week ]
    Collagen implant protrusion will be assessed by questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02699580


Locations
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Korea, Republic of
Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02699580    
Other Study ID Numbers: 4-2015-0741
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share individual participant data
Keywords provided by Yonsei University:
Biodegradable collagen implant
scleral thinning
strabismus surgery
Additional relevant MeSH terms:
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Strabismus
Exotropia
Ocular Motility Disorders
 Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases