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This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodegradable collagen implant | Experimental | Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant. |
|
| Without biodegradable collagen implant | Active Comparator | Strabismus surgery is done without placing of biodegradable collagen implant in the other eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lateral rectus recession with biodegradable collagen implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular discharge assessed by questionnaire | Ocular discharge will be assessed by questionnaire. | Postoperative 1 week |
| Tearing assessed by questionnaire | Tearing will be assessed by questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine | Seoul | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34516656 | Derived | 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. |
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no plan to share individual participant data
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|
| Lateral rectus recession without biodegradable collagen implantation | Procedure | Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation. |
|
| Postoperative 1 week |
| Foreign body sensation assessed by questionnaire | Foreign body sensation will be assessed by questionnaire. | Postoperative 1 week |
| Collagen implant protrusion assessed by questionnaire | Collagen implant protrusion will be assessed by questionnaire. | Postoperative 1 week |
| ID | Term |
|---|---|
| D005099 | Exotropia |
| ID | Term |
|---|---|
| D013285 | Strabismus |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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