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Intermittent ExotropiaNCT03321838

Office Based Vergence and Accommodative Therapy and Intermittent Exotropia

A study testing accommodative/vergence therapy in people with Intermittent Exotropia, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This pilot study is designed specifically to determine the short-term effect of OBVAT on intermittent exotropia in terms of 4 key areas (Standardizing reported outcomes of surgery for intermittent exotropia): control score, alignment, near stereoacuity and quality of life score. Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Intermittent Exotropia
What is being tested?
accommodative/vergence therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Nov 2017to 30 Dec 2018
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 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 8 to 18 years old
  • deviation meeting all of the following criteria: A. intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control> or = Grade 2) B. intermittent exotropia at near (at least 1 of 3 assessments of near control at the baseline visit Grade 2-4) C. distance and near exodeviation both between 15 to 35 prism diopters (PD) measured by prism and alternate cover test (PACT); D. near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type IXT excluded)
  • cycloplegic objective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +1.00 D inclusive in either eye
  • Patients must be wearing the updated refractive correction (spectacles or contact lenses) for at least 1 week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following:
  • Myopia >-0.50 D spherical equivalent in either eye B. Anisometropia >1.00 D spherical equivalent C. Astigmatism in either eye >1.50 D
  • Refractive correction must meet the following guidelines:
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  • Anisometropia spherical equivalent must be within 0.25 D of the full anisometropic difference B. Astigmatism cylinder must be within 0.25 D of full correction and axis must be within 5 degree C. 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 +1.50 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 IXT other than single vision refractive correction (e.g. PALs, Bifocals, patching, or deliberate over-minus with spectacles more than 0.50 D)
  • No vision therapy or orthoptics for any reason within the last year
  • No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery
  • No strabismus surgery planned
  • vision correctable to at least 20/25 or better at distance and near in each eye.
  • Px needs to have a computer at home which can connect to internet

Who cannot join

  • Patient with nystagmus, restrictive or paretic strabismus
  • Patient with amblyopia, which is defined as >or = 0.2 logarithm of the minimum angle of resolution units of interocular difference and > or = 0.3 logarithm of the minimum angle of resolution units in one eye ( Variability of stereoacuity in intermittent exotropia)
  • Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications in 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 for 2 years；
  • Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus
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  • Vertical deviation greater than 1 pd in cover test
  • Household member already in the study.
  • Any eye care professional, ophthalmic technician, medical student, or optometry student

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Pilot Study of Office Based Vergence and Accommodative Therapy as Treatment of Intermittent Exotropia

This pilot study is designed specifically to determine the short-term effect of OBVAT on intermittent exotropia in terms of 4 key areas (Standardizing reported outcomes of surgery for intermittent exotropia): control score, alignment, near stereoacuity and quality of life score. Result of this pilot study will be used to determine whether a full-scale RCT should be conducted to evaluate the short and long term effectiveness of OBVAT.

Read the detailed description

All enrolled px received 16-20 sessions of OBVAT, 60 minutes per visit, one time per week; Home reinforcement, 15 minutes each time, five times per week.

  1. Primary outcome measure： A. Change in the office based intermittent exotropia control score
  2. Secondary outcome measures A. Change in Look And Cover, then Ten seconds of Observation Scale for Exotropia (LACTOSE) B. Change in Newcastle Control Score (NCS) C. Change in Chinese intermittent exotropia questionnaire (CIXTQ) D. Change in near stereopsis by Preschool randot near stereoacuity E. Change in size of distant deviation angle by prism alternating cover test F. Change in size of near deviation angle by prism alternating cover test
Being tested
accommodative/vergence therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • accommodative/vergence therapyBehavioural

    Accommodative/vergence therapy (60 minutes per visit, one time per week, 12-14 weeks) and home reinforcement (15 minutes each time, five times per week, 12-14 weeks) will be provided to patients of treatment group. These therapy includes accommodative, vergence and anti-suppression technique. No drug is used during the whole therapy process.

Study groups in NCT03321838
Study groupRoleWhat they receive
Accommodative/vergence therapyExperimentalAccommodative/vergence therapy (60 minutes per visit, one time per week, 12-14 weeks) and home reinforcement (15 minutes each time, five times per week, 12-14 weeks) will be provided to patients of treatment group. These therapy includes accommodative, vergence and anti-suppression technique. No drug is used during the whole therapy process.
Receives: Behavioral: accommodative/vergence therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Office based intermittent exotropia control score

    Office based intermittent exotropia control score is an office based score to assess the control of intermittent exotropia. Minimum score is 0 (best score, phoria) and Maximum score is 5(worst score, constant tropia). Change in Office based intermittent exotropia control score after 14 weeks of vision therapy

    Measured: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

Secondary outcomes (5)

  1. Look And Cover, then Ten seconds of Observation Scale for Exotropia(LACTOSE)

    Look And Cover, then Ten seconds of Observation Scale for Exotropia (LACTOSE) is an office based score to assess the control of intermittent exotropia. Minimum score is 0 (best score, phoria) and Maximum score is 4(worst score, constant tropia). Change in score after 14 weeks of vision therapy.

    Measured: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

  2. Newcastle Control Score

    Newcastle Control Score is an office based and home based score to assess the control of intermittent exotropia. Minimum score is 0 (best score) and Maximum score is 6(worst score). Change in score after 14 weeks of vision therapy.Change in score after 14 weeks of vision therapy.

    Measured: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

  3. Chinese intermittent exotropia questionnaire

    Change in Chinese intermittent exotropia questionnaire after 14 weeks of vision therapy.

    Measured: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

  4. Preschool randot near stereoacuity

    Change in near stereopsis by Preschool randot near stereoacuity after 14 weeks of vision therapy.

    Measured: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

  5. deviation angle

    Change in size of distant deviation angle by prism alternating cover test after 14 weeks of vision therapy.

    Measured: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start1 Nov 2017
  3. Primary completion31 Jan 2018
  4. Study completion30 Dec 2018 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03321838
Sponsor's protocol ID
XT1
Status last verified
Jun 2018
First submitted
15 Oct 2017
Last updated
28 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ma MM, Kang Y, Scheiman M, Chen X. Office-based Vergence and Accommodative Therapy for the Treatment of Intermittent Exotropia: A Pilot Study. Optom Vis Sci. 2019 Dec;96(12):925-933. doi: 10.1097/OPX.0000000000001454.

    PubMed 31834152

Questions about this trial

What is this clinical trial studying?

A study testing accommodative/vergence therapy in people with Intermittent Exotropia, run by Sun Yat-sen University at 1 site in China.

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 15 inclusion and 9 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 28 Jun 2018. 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 China. 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?

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?

Office based intermittent exotropia control score (time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)). 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 NCT03321838, 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 28 Jun 2018.

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