An interventional study of lateral rectus recession with biodegradable collagen implant and Lateral rectus recession without biodegradable collagen implantation in Exotropia or Intermittent Exotropia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 10 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-25.
Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
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Exclusion Criteria:
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
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. 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.
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
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
Ocular discharge assessed by questionnaire
Ocular discharge will be assessed by questionnaire.
Time frame: Postoperative 1 week
Tearing assessed by questionnaire
Tearing will be assessed by questionnaire.
Time frame: Postoperative 1 week
Foreign body sensation assessed by questionnaire
Foreign body sensation will be assessed by questionnaire.
Time frame: Postoperative 1 week
Collagen implant protrusion assessed by questionnaire
Collagen implant protrusion will be assessed by questionnaire.
Time frame: Postoperative 1 week
Plan to share: No — no plan to share individual participant data
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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