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Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery | Clinical Trials | Clareo Health

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

NCT02699580•Yonsei University

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

10 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Key Dates

Start Date

September 30, 2015

Primary Completion Date

September 10, 2016

Completion Date

September 10, 2016

Last Updated

January 25, 2017

Enrollment

ACTUAL participants

Conditions

Exotropia or Intermittent Exotropia

Interventions

lateral rectus recession with biodegradable collagen implant

DEVICE

Lateral rectus recession without biodegradable collagen implantation

PROCEDURE