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Completed

NCT Number: NCT02699580

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

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

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Key information

Conditions

Exotropia or Intermittent Exotropia Cranial Nerve Diseases Exotropia Eye Diseases Nervous System Diseases Ocular Motility Disorders Strabismus

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lateral rectus recession with biodegradable collagen implant

Device

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 implantation

Procedure

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

Primary outcomes

  1. Scleral thinning assessed with slit photography

    Time frame: 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 outcomes

  1. Ocular discharge assessed by questionnaire

    Time frame: Postoperative 1 week

    Ocular discharge will be assessed by questionnaire.

  2. Tearing assessed by questionnaire

    Time frame: Postoperative 1 week

    Tearing will be assessed by questionnaire.

  3. Foreign body sensation assessed by questionnaire

    Time frame: Postoperative 1 week

    Foreign body sensation will be assessed by questionnaire.

  4. Collagen implant protrusion assessed by questionnaire

    Time frame: Postoperative 1 week

    Collagen implant protrusion will be assessed by questionnaire.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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