Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery

Exotropia or Intermittent Exotropia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699580
• Other study ID #: 4-2015-0741
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: January 24, 2017
• Start date: September 30, 2015
• Est. completion date: September 10, 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 10, 2016
• Est. primary completion date: September 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Exotropia
• Exotropia or Intermittent Exotropia
• Strabismus

Intervention

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.

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Ocular discharge assessed by questionnaire	Ocular discharge will be assessed by questionnaire.	Postoperative 1 week
Secondary	Tearing assessed by questionnaire	Tearing will be assessed by questionnaire.	Postoperative 1 week
Secondary	Foreign body sensation assessed by questionnaire	Foreign body sensation will be assessed by questionnaire.	Postoperative 1 week
Secondary	Collagen implant protrusion assessed by questionnaire	Collagen implant protrusion will be assessed by questionnaire.	Postoperative 1 week