Exotropia or Intermittent ExotropiaNCT02699580
Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
A study testing lateral rectus recession with biodegradable collagen implant and Lateral rectus recession without biodegradable collagen implantation in people with Exotropia or Intermittent Exotropia, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Exotropia or Intermittent Exotropia
- What is being tested?
- lateral rectus recession with biodegradable collagen implant and Lateral rectus recession without biodegradable collagen implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2015to 10 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, 03722
About this study
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
- Conditions
- Exotropia or Intermittent Exotropia
- Being tested
- lateral rectus recession with biodegradable collagen implant, Lateral rectus recession without biodegradable collagen implantation
- Keywords
- Biodegradable collagen implant, scleral thinning, strabismus surgery
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation.
| Study group | Role | What they receive |
|---|---|---|
| Biodegradable collagen implant | Experimental | Both eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant. Receives: Device: lateral rectus recession with biodegradable collagen implant |
| Without biodegradable collagen implant | Active comparator | Strabismus surgery is done without placing of biodegradable collagen implant in the other eye. Receives: Procedure: Lateral rectus recession without biodegradable collagen implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 3 months
Secondary outcomes (4)
Ocular discharge assessed by questionnaire
Ocular discharge will be assessed by questionnaire.
Measured: Postoperative 1 week
Tearing assessed by questionnaire
Tearing will be assessed by questionnaire.
Measured: Postoperative 1 week
Foreign body sensation assessed by questionnaire
Foreign body sensation will be assessed by questionnaire.
Measured: Postoperative 1 week
Collagen implant protrusion assessed by questionnaire
Collagen implant protrusion will be assessed by questionnaire.
Measured: Postoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start30 Sep 2015
- Primary completion10 Sep 2016
- Study completion10 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exotropia or Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699580
- Sponsor's protocol ID
- 4-2015-0741
- Status last verified
- Jan 2017
- First submitted
- 22 Feb 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share individual participant data
Publications
Pang Y, Gnanaraj L, Gayleard J, Han G, Hatt SR. Interventions for intermittent exotropia. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4.
PubMed 34516656
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery
- ClinicalTrials.gov ID
- NCT02699580
- Acronym / sponsor ID
- 4-2015-0741
- Conditions
- Exotropia or Intermittent Exotropia
- Keywords
- Biodegradable collagen implant, scleral thinning, strabismus surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 10 Sep 2016 (actual)
- Study completion
- 10 Sep 2016 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodegradable collagen implant | Experimental | Device: lateral rectus recession with biodegradable collagen implantBoth eyes are needed to correct strabismus. One eye is randomly selected for the placement of biodegradable collagen implant. |
| Without biodegradable collagen implant | Active comparator | Procedure: Lateral rectus recession without biodegradable collagen implantationStrabismus surgery is done without placing of biodegradable collagen implant in the other eye. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral rectus recession with biodegradable collagen implantExotropia 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. | Device | Biodegradable collagen implant |
| Lateral rectus recession without biodegradable collagen implantationExotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation. | Procedure or surgery | Without biodegradable collagen implant |
Primary outcome
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.
4 secondary outcomes
Ocular discharge assessed by questionnaire
Time frame: Postoperative 1 week
Tearing assessed by questionnaire
Time frame: Postoperative 1 week
Foreign body sensation assessed by questionnaire
Time frame: Postoperative 1 week
Collagen implant protrusion assessed by questionnaire
Time frame: Postoperative 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 34516656Pang Y, Gnanaraj L, Gayleard J, Han G, Hatt SR. Interventions for intermittent exotropia. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4.
- Individual participant dataSharing planned: No. no plan to share individual participant data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral rectus recession with biodegradable collagen implant and Lateral rectus recession without biodegradable collagen implantation in people with Exotropia or Intermittent Exotropia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scleral thinning assessed with slit photography (time frame: Postoperative 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02699580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.