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

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

Tracking Information

• First Submitted Date: February 22, 2016
• First Posted Date: March 4, 2016
• Last Update Posted Date: January 25, 2017
• Actual Study Start Date: September 30, 2015
• Actual Primary Completion Date: September 10, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Exotropia or Intermittent Exotropia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 29, 2016): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 10, 2016
• Actual Primary Completion Date: September 10, 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02699580
• Other Study ID Numbers: 4-2015-0741
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: no plan to share individual participant data

• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: January 2017