Status:
UNKNOWN
Office Based Vergence and Accommodative Therapy and Intermittent Exotropia
Lead Sponsor:
Sun Yat-sen University
Conditions:
Intermittent Exotropia
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief 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 exo...
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 ...
Eligibility Criteria
Inclusion
- 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:
- A. 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:
- A. 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03321838
Start Date
November 1 2017
End Date
December 30 2018
Last Update
June 28 2018
Active Locations (1)
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1
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510000