Office Based Vergence and Accommodative Therapy and Intermittent Exotropia

NCT03321838 | Unknown

• 1 other identifier: XT1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

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

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

• Newcastle Control Score

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

• Chinese intermittent exotropia questionnaire

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

• Preschool randot near stereoacuity

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

• deviation angle

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

Study Arms (1)

Accommodative/vergence therapy

EXPERIMENTAL

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.

Behavioral: accommodative/vergence therapy

Interventions

accommodative/vergence therapy BEHAVIORAL

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.

Accommodative/vergence therapy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 31834152 DERIVED

Study Officials

• Chen xiang

  associate chief physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate clinical professor

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 26, 2017
• Study Start: November 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: December 30, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

CN (1)