NCT03321838

Office Based Vergence and Accommodative Therapy and Intermittent Exotropia

Pilot Study of Office Based Vergence and Accommodative Therapy as Treatment of Intermittent Exotropia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Intermittent Exotropia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-01-31
• Completion: 2018-12-30
• First posted: 2017-10-26
• Last updated: 2018-06-28

Locations

1 site across 1 country: China