Exotropia or Intermittent Exotropia
Conditions
Keywords
Biodegradable collagen implant, scleral thinning, strabismus surgery
Brief summary
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
Interventions
DEVICElateral 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.
PROCEDURELateral 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with intermittent exotropia or constant exotropia 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
1. Subject who had previous strabismus surgery or other ocular surgery history 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scleral thinning assessed with slit photography | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foreign body sensation assessed by questionnaire | Postoperative 1 week | Foreign body sensation will be assessed by questionnaire. |
| Collagen implant protrusion assessed by questionnaire | Postoperative 1 week | Collagen implant protrusion will be assessed by questionnaire. |
| Ocular discharge assessed by questionnaire | Postoperative 1 week | Ocular discharge will be assessed by questionnaire. |
| Tearing assessed by questionnaire | Postoperative 1 week | Tearing will be assessed by questionnaire. |
Countries
South Korea
Outcome results
None listed