Intermittent ExotropiaNCT03700632
Part-time Patch Therapy for Treatment of Intermittent Exotropia
A study testing patch therapy in people with Intermittent Exotropia, run by Tehran University of Medical Sciences.
Trial summary
Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- patch therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 10 Nov 2021
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria
Who cannot join
- No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations
- Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction
- History of previous treatments including eye occlusion, minus therapy, and strabismus surgery
- Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Clinical Trial of Part-time Patching Therapy on Improvement of Deviation Control in 3 to 8 Year-old Children With Intermittent Exotropia
Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. According to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.
- Conditions
- Intermittent Exotropia
- Being tested
- patch therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patch therapyOther
The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week
| Study group | Role | What they receive |
|---|---|---|
| patch therapy | Experimental | The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week. Receives: Other: patch therapy |
| Control | No intervention | no intervention will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-point scale Deviation Control
the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor.
Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation.
Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen.
Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
Measured: 3 months after treatment
3-point scale Deviation Control
the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor.
Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation.
Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen.
Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
Measured: 6 months after treatent
6-point scale Deviation Control
the ability of the child to control his/her deviation at far and near was assessed based on the office control 6-point scale: Children are classified according to the office control 6-point scale into six groups of 0 to 5.
In this classification, exotropia is ranked after 30 seconds of observation: constant exotropia is ranked 5th, exotropia in more than 50% of the observing time is ranked 4th, and exotropia in less than 50% of the observing time is ranked 3rd. If exotropia is not seen in 30 seconds, the classification is made based on the speed of deviation control and fusion return 10 seconds after covering the eyes: back of fusion in more than 5 seconds is ranked 2nd, fusion return between 1 and 5 seconds ranked 1st, and fusion return in less than 1 second is ranked 0.
Measured: 3 months after treatment
Secondary outcomes (2)
Near stereopsis
Stereo acuity is measured at 40 cm using the Titmus test
Measured: at the time of enrollment, 3 month later and 6 month later
Fusion
fusion at far \& near are measured using the Worth 4-dot test. The Worth 4-dot test is used at 50 cm and 6 m for evaluating central and peripheral suppression.
Measured: at the time of enrollment, 3 month later and 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion10 May 2020 (estimated)
- Study completion10 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Reza Akbari, MD, Principal investigator, Farabi Eye Research Center, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700632
- Sponsor's protocol ID
- 9611257005
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu CB, Fan DS, Wong VW, Wong CY, Lam DS. Changing patterns of strabismus: a decade of experience in Hong Kong. Br J Ophthalmol. 2002 Aug;86(8):854-6. doi: 10.1136/bjo.86.8.854.
PubMed 12140202Multi-ethnic Pediatric Eye Disease Study Group. Prevalence of amblyopia and strabismus in African American and Hispanic children ages 6 to 72 months the multi-ethnic pediatric eye disease study. Ophthalmology. 2008 Jul;115(7):1229-1236.e1. doi: 10.1016/j.ophtha.2007.08.001. Epub 2007 Oct 22.
PubMed 17953989Vishnoi SK, Singh V, Mehra MK. Role of occlusion in treatment of intermittent exotropia. Indian J Ophthalmol. 1987 Jul-Aug;35(4):207-10. No abstract available.
PubMed 3506931Pediatric Eye Disease Investigator Group; Cotter SA, Mohney BG, Chandler DL, Holmes JM, Repka MX, Melia M, Wallace DK, Beck RW, Birch EE, Kraker RT, Tamkins SM, Miller AM, Sala NA, Glaser SR. A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology. 2014 Dec;121(12):2299-310. doi: 10.1016/j.ophtha.2014.07.021. Epub 2014 Sep 16.
PubMed 25234012Spoor DK, Hiles DA. Occlusion therapy for exodeviations occurring in infants and young children. Ophthalmology. 1979 Dec;86(12):2152-7. doi: 10.1016/s0161-6420(79)35295-2.
PubMed 555806Freeman RS, Isenberg SJ. The use of part-time occlusion for early onset unilateral exotropia. J Pediatr Ophthalmol Strabismus. 1989 Mar-Apr;26(2):94-6. doi: 10.3928/0191-3913-19890301-14.
PubMed 2709283Chutter CP. Occlusion treatment of intermittent divergent strabismus. Am Orthopt J. 1977;27:80-4. No abstract available.
PubMed 900625IACOBUCCI I, HENDERSON JW. OCCLUSION IN THE PREOPERATIVE TREATMENT OF EXODEVIATIONS. Am Orthopt J. 1965;15:42-7. No abstract available.
PubMed 14274107Suh YW, Kim SH, Lee JY, Cho YA. Conversion of intermittent exotropia types subsequent to part-time occlusion therapy and its sustainability. Graefes Arch Clin Exp Ophthalmol. 2006 Jun;244(6):705-8. doi: 10.1007/s00417-005-0195-0. Epub 2006 Feb 4.
PubMed 16463040AlKahmous LS, Al-Saleh AA. Does occlusion therapy improve control in intermittent exotropia? Saudi J Ophthalmol. 2016 Oct-Dec;30(4):240-243. doi: 10.1016/j.sjopt.2016.07.004. Epub 2016 Jul 25.
PubMed 28003783Coffey B, Wick B, Cotter S, Scharre J, Horner D. Treatment options in intermittent exotropia: a critical appraisal. Optom Vis Sci. 1992 May;69(5):386-404. doi: 10.1097/00006324-199205000-00008.
PubMed 1594200Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus. 2006 Sep;14(3):147-50. doi: 10.1080/09273970600894716.
PubMed 16950743Akbari MR, Mehrpour M, Mirmohammadsadeghi A. The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1625-1633. doi: 10.1007/s00417-020-05065-0. Epub 2021 Jan 7.
PubMed 33415357
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Part-time Patching Therapy on Improvement of Deviation Control in 3 to 8 Year-old Children With Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT03700632
- Acronym / sponsor ID
- 9611257005
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 10 May 2020 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 9 Oct 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.
Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. According to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.
| Arm | Type | Receives |
|---|---|---|
| patch therapy | Experimental | Other: patch therapyThe eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week. |
| Control | No intervention | –no intervention will be done |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria
Key exclusion criteria (4 listed)
- No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations
- Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction
- History of previous treatments including eye occlusion, minus therapy, and strabismus surgery
- Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
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 |
|---|---|---|
| patch therapyThe eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week | Other | patch therapy |
Primary outcome
3-point scale Deviation Control
Time frame: 3 months after treatment
the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
3-point scale Deviation Control
Time frame: 6 months after treatent
the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.
6-point scale Deviation Control
Time frame: 3 months after treatment
the ability of the child to control his/her deviation at far and near was assessed based on the office control 6-point scale: Children are classified according to the office control 6-point scale into six groups of 0 to 5. In this classification, exotropia is ranked after 30 seconds of observation: constant exotropia is ranked 5th, exotropia in more than 50% of the observing time is ranked 4th, and exotropia in less than 50% of the observing time is ranked 3rd. If exotropia is not seen in 30 seconds, the classification is made based on the speed of deviation control and fusion return 10 seconds after covering the eyes: back of fusion in more than 5 seconds is ranked 2nd, fusion return between 1 and 5 seconds ranked 1st, and fusion return in less than 1 second is ranked 0.
2 secondary outcomes
Near stereopsis
Time frame: at the time of enrollment, 3 month later and 6 month later
Fusion
Time frame: at the time of enrollment, 3 month later and 6 month later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Background: PubMed 12140202Yu CB, Fan DS, Wong VW, Wong CY, Lam DS. Changing patterns of strabismus: a decade of experience in Hong Kong. Br J Ophthalmol. 2002 Aug;86(8):854-6. doi: 10.1136/bjo.86.8.854.
- Background: PubMed 17953989Multi-ethnic Pediatric Eye Disease Study Group. Prevalence of amblyopia and strabismus in African American and Hispanic children ages 6 to 72 months the multi-ethnic pediatric eye disease study. Ophthalmology. 2008 Jul;115(7):1229-1236.e1. doi: 10.1016/j.ophtha.2007.08.001. Epub 2007 Oct 22.
- Background: PubMed 3506931Vishnoi SK, Singh V, Mehra MK. Role of occlusion in treatment of intermittent exotropia. Indian J Ophthalmol. 1987 Jul-Aug;35(4):207-10. No abstract available.
- Background: PubMed 25234012Pediatric Eye Disease Investigator Group; Cotter SA, Mohney BG, Chandler DL, Holmes JM, Repka MX, Melia M, Wallace DK, Beck RW, Birch EE, Kraker RT, Tamkins SM, Miller AM, Sala NA, Glaser SR. A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology. 2014 Dec;121(12):2299-310. doi: 10.1016/j.ophtha.2014.07.021. Epub 2014 Sep 16.
- Background: PubMed 555806Spoor DK, Hiles DA. Occlusion therapy for exodeviations occurring in infants and young children. Ophthalmology. 1979 Dec;86(12):2152-7. doi: 10.1016/s0161-6420(79)35295-2.
- Background: PubMed 2709283Freeman RS, Isenberg SJ. The use of part-time occlusion for early onset unilateral exotropia. J Pediatr Ophthalmol Strabismus. 1989 Mar-Apr;26(2):94-6. doi: 10.3928/0191-3913-19890301-14.
- Background: PubMed 900625Chutter CP. Occlusion treatment of intermittent divergent strabismus. Am Orthopt J. 1977;27:80-4. No abstract available.
- Background: PubMed 14274107IACOBUCCI I, HENDERSON JW. OCCLUSION IN THE PREOPERATIVE TREATMENT OF EXODEVIATIONS. Am Orthopt J. 1965;15:42-7. No abstract available.
- Background: PubMed 16463040Suh YW, Kim SH, Lee JY, Cho YA. Conversion of intermittent exotropia types subsequent to part-time occlusion therapy and its sustainability. Graefes Arch Clin Exp Ophthalmol. 2006 Jun;244(6):705-8. doi: 10.1007/s00417-005-0195-0. Epub 2006 Feb 4.
- Background: PubMed 28003783AlKahmous LS, Al-Saleh AA. Does occlusion therapy improve control in intermittent exotropia? Saudi J Ophthalmol. 2016 Oct-Dec;30(4):240-243. doi: 10.1016/j.sjopt.2016.07.004. Epub 2016 Jul 25.
- Background: PubMed 1594200Coffey B, Wick B, Cotter S, Scharre J, Horner D. Treatment options in intermittent exotropia: a critical appraisal. Optom Vis Sci. 1992 May;69(5):386-404. doi: 10.1097/00006324-199205000-00008.
- Background: PubMed 16950743Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus. 2006 Sep;14(3):147-50. doi: 10.1080/09273970600894716.
- 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.
Mohammad Reza Akbari, MD principal investigator
Farabi Eye Research Center, Tehran University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing patch therapy in people with Intermittent Exotropia, run by Tehran University of Medical Sciences.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Mehrpour, MD (00989125011468, m.mehrpur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-point scale Deviation Control (time frame: 3 months after treatment). The study lists 3 primary outcomes in all. 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 NCT03700632, which also lists 13 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 9 Oct 2018.