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

Not Applicable

Completed

• Conditions: Exotropia or Intermittent Exotropia
• Interventions: Device: lateral rectus recession with biodegradable collagen implant; Procedure: Lateral rectus recession without biodegradable collagen implantation

• Registration Number: NCT02699580
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Primary Completion: 2016-09-10
• Study Completion: 2016-09-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biodegradable collagen implant	lateral rectus recession with biodegradable collagen implant	Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant.
Without biodegradable collagen implant	Lateral rectus recession without biodegradable collagen implantation	Strabismus surgery is done without placing of biodegradable collagen implant in the other eye.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Foreign body sensation assessed by questionnaire	Postoperative 1 week	Foreign body sensation will be assessed by questionnaire.
Tearing assessed by questionnaire	Postoperative 1 week	Tearing will be assessed by questionnaire.
Ocular discharge assessed by questionnaire	Postoperative 1 week	Ocular discharge will be assessed by questionnaire.
Collagen implant protrusion assessed by questionnaire	Postoperative 1 week	Collagen implant protrusion will be assessed by questionnaire.

Trial Locations

Locations (1)

Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of