Clinical Trial: Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
Brief Summary: The purpose of this study is to determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia.
Detailed Summary:
Sponsor: Sun Yat-sen University
Current Primary Outcome:
- Ocular alignment (Prism alternative cover test) [ Time Frame: 5 years ]
- Binocular stereopsis at distance and near (Random dot stereopsis test) [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Newcastle control scores [ Time Frame: 5 years ]
- The intermittent exotropia questionnaire [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Sun Yat-sen University
Dates:
Date Received: April 3, 2016
Date Started: November 2015
Date Completion: November 2020
Last Updated: April 7, 2016
Last Verified: April 2016