Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia

NCT04744779 | Unknown

• 1 other identifier: XT4
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

• 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

  16 months

Secondary Outcomes (1)

• Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score

  16 months

Other Outcomes (1)

• Comparison of deterioration rate between 2 groups

  16 months

Study Arms (2)

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)

Behavioral: Office-based accommodative/vergence therapy and home reinforcement

Interventions

Office-based accommodative/vergence therapy and home reinforcement BEHAVIORAL

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)

Office-based accommodative/vergence therapy and home reinforcement

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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
• 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:
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Salus University: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share