Clinical Trial: A Prospective Observational Study of Adult Strabismus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Prospective Observational Study of Adult Strabismus

Brief Summary: The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia.

Detailed Summary: The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Treatment comparisons within the studied conditions will also be done to help develop future studies.
Sponsor: Jaeb Center for Health Research

Current Primary Outcome:

• Symptom Success at 10 Weeks [ Time Frame: 10 weeks after enrollment ]
  In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.
• Symptom Success at 12 Months [ Time Frame: 12 months after enrollment ]
  In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Motor alignment [ Time Frame: 12 months after enrollment ]
• Near point of convergence [ Time Frame: 12 months after enrollment ]
  Near point of convergence (convergence insufficiency group only)
• Positive fusional vergence [ Time Frame: 12 months after enrollment ]
  Positive fusional vergence (convergence insufficiency group only)
• Negative fusional vergence [ Time Frame: 12 months after enrollment ]
  Negative fusional vergence (divergence insufficiency group only)
• Vertical fusional vergence [ Time Frame: 12 months after enrollment ]
  Vertical fusional vergence (small-angle hypertropia group only)
• Adult Strabismus 20 Questionnaire Score [ Time Frame: 12 months after enrollment ]
• Mean Convergence Insufficiency Symptom Survey Score [ Time Frame: 12 months after enrollment ]
  Mean Convergence Insufficiency Symptom Survey Score (convergence insufficiency group only)

Original Secondary Outcome: Same as current

Information By: Jaeb Center for Health Research

Dates:
Date Received: July 24, 2015
Date Started: August 2015
Date Completion: August 2019
Last Updated: June 24, 2016
Last Verified: June 2016