Back to resultsProtective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
Primary Purpose
Exotropia or Intermittent Exotropia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lateral rectus recession with biodegradable collagen implant
Lateral rectus recession without biodegradable collagen implantation
Sponsored by
About this trial
This is an interventional supportive care trial for Exotropia or Intermittent Exotropia focused on measuring Biodegradable collagen implant, scleral thinning, strabismus surgery
Eligibility Criteria
Inclusion Criteria:
- Patients with intermittent exotropia or constant exotropia
- Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
- Subjects who want to do strabismus surgery
Exclusion Criteria:
- Subject who had previous strabismus surgery or other ocular surgery history
- Thyroid eye disease or other connective tissue disease
- Significant bleeding or scleral perforation during operation
- Subjects who need to do medial rectus resection, not lateral rectus recession
- Subjects who had a plan to do other intra or extraocular surgery within 3 months
Sites / Locations
- Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biodegradable collagen implant
Without biodegradable collagen implant
Arm Description
Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.
Outcomes
Primary Outcome Measures
Scleral thinning assessed with slit photography
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
Ocular discharge assessed by questionnaire
Ocular discharge will be assessed by questionnaire.
Tearing assessed by questionnaire
Tearing will be assessed by questionnaire.
Foreign body sensation assessed by questionnaire
Foreign body sensation will be assessed by questionnaire.
Collagen implant protrusion assessed by questionnaire
Collagen implant protrusion will be assessed by questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02699580
Brief Title
Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (Actual)
Primary Completion Date
September 10, 2016 (Actual)
Study Completion Date
September 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exotropia or Intermittent Exotropia
Keywords
Biodegradable collagen implant, scleral thinning, strabismus surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodegradable collagen implant
Arm Type
Experimental
Arm Description
Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
Arm Title
Without biodegradable collagen implant
Arm Type
Active Comparator
Arm Description
Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.
Intervention Type
Device
Intervention Name(s)
lateral rectus recession with biodegradable collagen implant
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lateral rectus recession without biodegradable collagen implantation
Intervention Description
Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation.
Primary Outcome Measure Information:
Title
Scleral thinning assessed with slit photography
Description
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.
Time Frame
Postoperative 3 months
Secondary Outcome Measure Information:
Title
Ocular discharge assessed by questionnaire
Description
Ocular discharge will be assessed by questionnaire.
Time Frame
Postoperative 1 week
Title
Tearing assessed by questionnaire
Description
Tearing will be assessed by questionnaire.
Time Frame
Postoperative 1 week
Title
Foreign body sensation assessed by questionnaire
Description
Foreign body sensation will be assessed by questionnaire.
Time Frame
Postoperative 1 week
Title
Collagen implant protrusion assessed by questionnaire
Description
Collagen implant protrusion will be assessed by questionnaire.
Time Frame
Postoperative 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with intermittent exotropia or constant exotropia
Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
Subjects who want to do strabismus surgery
Exclusion Criteria:
Subject who had previous strabismus surgery or other ocular surgery history
Thyroid eye disease or other connective tissue disease
Significant bleeding or scleral perforation during operation
Subjects who need to do medial rectus resection, not lateral rectus recession
Subjects who had a plan to do other intra or extraocular surgery within 3 months
Facility Information:
Facility Name
Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share individual participant data
Citations:
PubMed Identifier
34516656
Citation
Pang Y, Gnanaraj L, Gayleard J, Han G, Hatt SR. Interventions for intermittent exotropia. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4.
Results Reference
derived
Learn more about this trial
Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
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