An interventional study of accommodative/vergence therapy in Intermittent Exotropia, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-06-28.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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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
Exclusion Criteria:
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
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.
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)
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)
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Jan 2018, 2 months.
Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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