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
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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|
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.
- 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.
- 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.
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
|Korea, Republic of|
|Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine|
|Seoul, Korea, Republic of, 03722|