Intermittent ExotropiaNCT04744779
Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia
A study testing Office-based accommodative/vergence therapy and home reinforcement in people with Intermittent Exotropia, run by Sun Yat-sen University.
Trial summary
Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Office-based accommodative/vergence therapy and home reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jun 2023
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 to <18 years old
- Distance exodeviation between 10 and 30 prism diopters (PD) measured by prism and alternate cover test (PACT)
- Near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type intermittent exotropia excluded)
- Control of deviation meeting all the following criteria based on the office control score scale:
- 4.1 Intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control ≥ Grade 2)# 4.2 Intermittent exotropia or exophoria at near (at least 1 of 3 assessments of near control at the baseline visit Grade 0-4) or orthophoria
- Stereoacuity: near stereoacuity of 400 arcsec or better by the Preschool Randot stereotest
Show all 19Show fewer
- Cycloplegic subjective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +3.50 D inclusive in either eye
- Must be wearing the updated refractive correction (spectacles) for at least 2 weeks if refractive error (based on cycloplegic subjective refraction performed within 6 months) meets any of the following:
- 7.1 Myopia >-0.50 D spherical equivalent in either eye 7.2 Anisometropia >1.00 D spherical equivalent 7.3 Astigmatism in either eye >1.50 D
- Refractive correction must meet the following guidelines:
- 8.1 Anisometropia spherical equivalent must be within 0.25 D of the full anisometropic difference 8.2 Astigmatism cylinder must be within 0.25 D of full correction and axis must be within 5 degree 8.3 For hyperopia and myopia, the spherical component can be reduced by investigator discretion provided reduction is symmetrical and results in residual (i.e., uncorrected) spherical equivalent refractive error that does not exceed +3.50 D spherical equivalent hyperopia or -0.50 D spherical equivalent myopia
- Gestational age >34 weeks
- Birth weight >1500 g
- No previous surgical or nonsurgical treatment for intermittent exotropia other than single vision refractive correction (e.g. progressive addition lens, bifocals, patching, or deliberate over-minus with spectacles >0.50 D)
- No prior office-based vision therapy for any reason
- No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery
- No planned strabismus surgery
- Visual acuity correctable to at least 20/25 or better at distance and near in each eye.
- Inclusion criteria 4.1 may be changed to "Intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control ≥ Grade 1" if there is difficulty in patient recruitment.
Who cannot join
- Amblyopia, nystagmus, restrictive or paretic strabismus
- Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications, in the most recent 3 months
- Developmental disability, attention-deficit/hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment
- Relocation anticipated within 2 year
- Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus
- Vertical deviation greater than 3 pd
- Household member already in the study
About this study
Official title: Effectiveness of Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia: A Randomized Clinical Trial
Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial
Read the detailed description
Purpose of study:
- To evaluate the short-term effectiveness of office based vergence/accommodative therapy (OBVAT) for improving control of intermittent exotropia compared to observation alone; ii) To evaluate the long-term effectiveness of OBVAT for improving control of intermittent exotropia compared to observation alone; iii) To determine the natural history of intermittent exotropia among patients aged 6 to < 18 years who have baseline near stereoacuity of 400 arc sec or better using the Preschool Randot stereotest
- Conditions
- Intermittent Exotropia
- Being tested
- Office-based accommodative/vergence therapy and home reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office-based accommodative/vergence therapy and home reinforcementBehavioural
Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Observation only. |
| Office-based accommodative/vergence therapy and home reinforcement | Experimental | Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks) Receives: Behavioral: Office-based accommodative/vergence therapy and home reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the distant office control score between two groups at the primary outcome visit
Comparison of the distant office control score between two groups at the primary outcome visit
Measured: 16 months
Secondary outcomes (1)
Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Salus University
- Responsible party
- Principal investigator, Ying Kang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744779
- Sponsor's protocol ID
- XT4
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04744779
- Acronym / sponsor ID
- XT4
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Salus University
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 9 Feb 2021 (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.
Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial
Detailed description
Purpose of study:
- To evaluate the short-term effectiveness of office based vergence/accommodative therapy (OBVAT) for improving control of intermittent exotropia compared to observation alone; ii) To evaluate the long-term effectiveness of OBVAT for improving control of intermittent exotropia compared to observation alone; iii) To determine the natural history of intermittent exotropia among patients aged 6 to < 18 years who have baseline near stereoacuity of 400 arc sec or better using the Preschool Randot stereotest
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Observation only. |
| Office-based accommodative/vergence therapy and home reinforcement | Experimental | Behavioral: Office-based accommodative/vergence therapy and home reinforcementOffice-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- 6 to <18 years old
- Distance exodeviation between 10 and 30 prism diopters (PD) measured by prism and alternate cover test (PACT)
- Near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type intermittent exotropia excluded)
- Control of deviation meeting all the following criteria based on the office control score scale:
- 4.1 Intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control ≥ Grade 2)# 4.2 Intermittent exotropia or exophoria at near (at least 1 of 3 assessments of near control at the baseline visit Grade 0-4) or orthophoria
Key exclusion criteria (7 listed)
- Amblyopia, nystagmus, restrictive or paretic strabismus
- Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications, in the most recent 3 months
- Developmental disability, attention-deficit/hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment
- Relocation anticipated within 2 year
- Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus
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 |
|---|---|---|
| Office-based accommodative/vergence therapy and home reinforcementOffice-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks) | Behavioural | Office-based accommodative/vergence therapy and home reinforcement |
Primary outcome
Comparison of the distant office control score between two groups at the primary outcome visit
Time frame: 16 months
Comparison of the distant office control score between two groups at the primary outcome visit
1 secondary outcome
Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Office-based accommodative/vergence therapy and home reinforcement in people with Intermittent Exotropia, run by Sun Yat-sen University.
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 19 inclusion and 7 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 23 Feb 2021. 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?
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?
Comparison of the distant office control score between two groups at the primary outcome visit (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.