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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02699580

Collaborator

(none)

Enrollment

Location

Arms

11.4

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Exotropia or Intermittent Exotropia	Device: lateral rectus recession with biodegradable collagen implant Procedure: Lateral rectus recession without biodegradable collagen implantation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Actual Study Start Date :

Sep 30, 2015

Actual Primary Completion Date :

Sep 10, 2016

Actual Study Completion Date :

Sep 10, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biodegradable collagen implant 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 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.
Active Comparator: Without 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 in the other eye without placing biodegradable collagen implantation.

Arm

Intervention/Treatment

Experimental: Biodegradable collagen implant

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

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.

Active Comparator: Without 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 in the other eye without placing biodegradable collagen implantation.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with intermittent exotropia or constant exotropia
Alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia
Subjects who want to do strabismus surgery

Exclusion Criteria:

Subject who had previous strabismus surgery or other ocular surgery history
Thyroid eye disease or other connective tissue disease
Significant bleeding or scleral perforation during operation
Subjects who need to do medial rectus resection, not lateral rectus recession
Subjects who had a plan to do other intra or extraocular surgery within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02699580

Other Study ID Numbers:

4-2015-0741

First Posted:

Mar 4, 2016

Last Update Posted:

Jan 25, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Yonsei University

Biodegradable collagen implant

scleral thinning

strabismus surgery

Additional relevant MeSH terms:

Strabismus

Exotropia

Study Results

No Results Posted as of Jan 25, 2017