Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
NCT ID: NCT02699580
Last Updated: 2017-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-09-30
2016-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Biodegradable collagen implant
Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
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.
Without biodegradable collagen implant
Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
10 Years
70 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, South Korea
Countries
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References
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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.
Other Identifiers
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4-2015-0741
Identifier Type: -
Identifier Source: org_study_id
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