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

Yonsei University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Exotropia or Intermittent Exotropia

Interventions

lateral rectus recession with biodegradable collagen implantDEVICE

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.

Lateral rectus recession without biodegradable collagen implantationPROCEDURE

Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Postoperative 3 months

Secondary Outcomes

Ocular discharge assessed by questionnaire

Ocular discharge will be assessed by questionnaire.

Time frame: Postoperative 1 week

Tearing assessed by questionnaire

Tearing will be assessed by questionnaire.

Time frame: Postoperative 1 week

Foreign body sensation assessed by questionnaire

Foreign body sensation will be assessed by questionnaire.

Time frame: Postoperative 1 week

Collagen implant protrusion assessed by questionnaire

Collagen implant protrusion will be assessed by questionnaire.

Time frame: Postoperative 1 week

Data from ClinicalTrials.gov

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