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

January 24, 2017 updated by: Yonsei University
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular discharge assessed by questionnaire
Time Frame: Postoperative 1 week
Ocular discharge will be assessed by questionnaire.
Postoperative 1 week
Tearing assessed by questionnaire
Time Frame: Postoperative 1 week
Tearing will be assessed by questionnaire.
Postoperative 1 week
Foreign body sensation assessed by questionnaire
Time Frame: Postoperative 1 week
Foreign body sensation will be assessed by questionnaire.
Postoperative 1 week
Collagen implant protrusion assessed by questionnaire
Time Frame: Postoperative 1 week
Collagen implant protrusion will be assessed by questionnaire.
Postoperative 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2015

Primary Completion (Actual)

September 10, 2016

Study Completion (Actual)

September 10, 2016

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share individual participant data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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