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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
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
Time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
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.
Time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
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.
Time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Chinese intermittent exotropia questionnaire
Change in Chinese intermittent exotropia questionnaire after 14 weeks of vision therapy.
Time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Preschool randot near stereoacuity
Change in near stereopsis by Preschool randot near stereoacuity after 14 weeks of vision therapy.
Time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
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deviation angle
Change in size of distant deviation angle by prism alternating cover test after 14 weeks of vision therapy.
Time frame: Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)