Intermittent ExotropiaNCT03661476
The Effect of Oculo-Motor Exercises in Intermittent Exotropia
A study testing Oculo-Motor Exercises (OME) in people with Intermittent Exotropia and Exercises, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
In childhood strabismus, exotropia is most frequently seen with intermittent exotropia and convergence failure in the first decade of life. This situation adversely affects children's psychosocial development and creates worries about personal relationships and work life in their future lives. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Exotropia, Exercises
- What is being tested?
- Oculo-Motor Exercises (OME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2018to 3 Jan 2019
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be between 2 and 17 years of age
- Intermittent exotropia diagnosis
- To have mental capacity in the level to understand and do exercises
Who cannot join
- Not complying with age criteria
- Constant exotropia
- Having undergone eye surgery
- Those with systemic disease that prevent exercise
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: Investigation of the Effect of Oculo-Motor Exercises in Intermittent Exotropic Children
In childhood strabismus, exotropia is most frequently seen with intermittent exotropia and convergence failure in the first decade of life. This situation adversely affects children's psychosocial development and creates worries about personal relationships and work life in their future lives. Patients' hesitant attitudes towards surgical treatment led to the out-of-surgery techniques such as exercise therapy. No studies have been found in the literature on the efficancy of the intermittent exotropia treatments with oculo-motor exercises. In our study, it was aimed to investigate the effects of oculo-motor exercises on intermittent exotropia in children.
Read the detailed description
50 volunteer school-aged children between 2-17 years of age) were included in our study. Oculo-motor home exercise protocols were given to all participants for 2 sessions per day for 6 weeks, and regular phone calls were made once a week. Participants were assessed cycloplegic refraction by autorefractometry, corrected and uncorrected visual acuity by snellen chart, ocular motility test, near and distant alternating prism cover test, streopsis test and patient satisfaction levels by intermittent exotropia survery.
- Conditions
- Intermittent Exotropia, Exercises
- Being tested
- Oculo-Motor Exercises (OME)
- Keywords
- Intermittent Exotropia, Oculo-Motor Exercises, Physiotherapy, Intermittent Exotropia Survey
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculo-Motor Exercises (OME)Behavioural
Oculomotor Exercises (OME); The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still.
The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still.
The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus.
The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes.
| Study group | Role | What they receive |
|---|---|---|
| Oculo-Motor Exercises (OME) | Experimental | 10 repetitive four different oculomotor exercise protocols with eye stabilization were organized as home programs for 6 weeks, twice a day in the morning and evening each day of the week. Receives: Behavioral: Oculo-Motor Exercises (OME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prism cover test
Near and distant alternating prism cover test
Measured: 6 weeks
Secondary outcomes (3)
Streopsis test
Three-dimensional visual assessment
Measured: 6 weeks
Intermittent exotropia survery
Level of patient satisfaction
Measured: 6 weeks
Visual acuity
Snellen chart
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start13 Aug 2018
- Primary completion10 Dec 2018
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Aras, Medipol University
- Investigators
- Candan Algun, Study director, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661476
- Sponsor's protocol ID
- 10840098-604.01.01-E.34141
- Status last verified
- Mar 2019
- First submitted
- 5 Sep 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Govindan M, Mohney BG, Diehl NN, Burke JP. Incidence and types of childhood exotropia: a population-based study. Ophthalmology. 2005 Jan;112(1):104-8. doi: 10.1016/j.ophtha.2004.07.033.
PubMed 15629828Joyce KE, Beyer F, Thomson RG, Clarke MP. A systematic review of the effectiveness of treatments in altering the natural history of intermittent exotropia. Br J Ophthalmol. 2015 Apr;99(4):440-50. doi: 10.1136/bjophthalmol-2013-304627. Epub 2014 Jul 7.
PubMed 25001323Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.
PubMed 21334899
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Oculo-Motor Exercises in Intermittent Exotropic Children
- ClinicalTrials.gov ID
- NCT03661476
- Acronym / sponsor ID
- 10840098-604.01.01-E.34141
- Conditions
- Intermittent Exotropia, Exercises
- Keywords
- Intermittent Exotropia, Oculo-Motor Exercises, Physiotherapy, Intermittent Exotropia Survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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.
In childhood strabismus, exotropia is most frequently seen with intermittent exotropia and convergence failure in the first decade of life. This situation adversely affects children's psychosocial development and creates worries about personal relationships and work life in their future lives. Patients' hesitant attitudes towards surgical treatment led to the out-of-surgery techniques such as exercise therapy. No studies have been found in the literature on the efficancy of the intermittent exotropia treatments with oculo-motor exercises. In our study, it was aimed to investigate the effects of oculo-motor exercises on intermittent exotropia in children.
Detailed description
50 volunteer school-aged children between 2-17 years of age) were included in our study. Oculo-motor home exercise protocols were given to all participants for 2 sessions per day for 6 weeks, and regular phone calls were made once a week. Participants were assessed cycloplegic refraction by autorefractometry, corrected and uncorrected visual acuity by snellen chart, ocular motility test, near and distant alternating prism cover test, streopsis test and patient satisfaction levels by intermittent exotropia survery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oculo-Motor Exercises (OME) | Experimental | Behavioral: Oculo-Motor Exercises (OME)10 repetitive four different oculomotor exercise protocols with eye stabilization were organized as home programs for 6 weeks, twice a day in the morning and evening each day of the week. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Be between 2 and 17 years of age
- Intermittent exotropia diagnosis
- To have mental capacity in the level to understand and do exercises
Key exclusion criteria (4 listed)
- Not complying with age criteria
- Constant exotropia
- Having undergone eye surgery
- Those with systemic disease that prevent exercise
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 |
|---|---|---|
| Oculo-Motor Exercises (OME)Oculomotor Exercises (OME); The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still. The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still. The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus. The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes. | Behavioural | Oculo-Motor Exercises (OME) |
Primary outcome
Prism cover test
Time frame: 6 weeks
Near and distant alternating prism cover test
3 secondary outcomes
Streopsis test
Time frame: 6 weeks
Intermittent exotropia survery
Time frame: 6 weeks
Visual acuity
Time frame: 6 weeks
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 17 Dec 2019.
- Results publication: PubMed 15629828Govindan M, Mohney BG, Diehl NN, Burke JP. Incidence and types of childhood exotropia: a population-based study. Ophthalmology. 2005 Jan;112(1):104-8. doi: 10.1016/j.ophtha.2004.07.033.
- Results publication: PubMed 25001323Joyce KE, Beyer F, Thomson RG, Clarke MP. A systematic review of the effectiveness of treatments in altering the natural history of intermittent exotropia. Br J Ophthalmol. 2015 Apr;99(4):440-50. doi: 10.1136/bjophthalmol-2013-304627. Epub 2014 Jul 7.
- Results publication: PubMed 21334899Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.
- Individual participant dataSharing planned: No
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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.
Candan Algun study director
Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculo-Motor Exercises (OME) in people with Intermittent Exotropia and Exercises, run by Medipol University at 1 site in Turkey (Türkiye).
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 4 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 17 Dec 2019. 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 Turkey (Türkiye). 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?
Prism cover test (time frame: 6 weeks). 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 NCT03661476, which also lists 3 linked publications.
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 17 Dec 2019.