Full Text View
Tabular View
No Study Results Posted
Related Studies
Convergence Insufficiency Treatment Trial (CITT)
This study is ongoing, but not recruiting participants.
Study NCT00338611   Information provided by National Eye Institute (NEI)
First Received: June 15, 2006   Last Updated: October 27, 2008   History of Changes

June 15, 2006
October 27, 2008
July 2005
September 2008   (final data collection date for primary outcome measure)
Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey
Complete list of historical versions of study NCT00338611 on ClinicalTrials.gov Archive Site
Eyes' ability to converge when performing close work [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Eyes' ability to converge when performing close work
 
Convergence Insufficiency Treatment Trial (CITT)
Convergence Insufficiency Treatment Trial (CITT)

The purposes of the CITT are:

  • To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than placebo treatment, and whether there are differences between the three treatments in improving subject symptoms and signs.
  • To evaluate whether improvements in outcome measures are still present after one year of observation.

Convergence insufficiency is a prevalent and distinct binocular vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. It affects approximately 5% of children in the United States, and may have a serious impact on an individual's performance in school, choice of jobs, and quality of life.

There is no consensus regarding the most effective treatment for convergence insufficiency. Two commonly prescribed treatments are home-based pencil push-up therapy and office-based vision therapy/orthoptics. Significant differences exist between these two treatment modalities in cost and number of office visits required, with pencil push-up therapy being less expensive and less time intensive. There have been no well-designed studies that have compared the effectiveness of these two treatments.

The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked, placebo-controlled, multi-center clinical trial in which 208 subjects between the ages of 9 to < 18 years will be randomly assigned to: 1) Home-based Pencil Push-Up Therapy, 2) Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics, 3) Office-based Vision Therapy/Orthoptics, or 4) Placebo Office-based Vision Therapy/Orthoptics. The primary outcome measure is a measure of symptoms using a 15-item survey, the CI Symptom Survey. Secondary outcome measures are two common clinical tests of the eyes' ability to converge when performing close work. Patients will be tested at the eligibility examination, and by masked examiners after 4, 8 and 12 weeks of treatment have been completed during the 12-week treatment phase. Long term follow-up will be assessed at 6 and 12 months after the completion of active treatment.

Phase III
Interventional
Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
  • Convergence Insufficiency
  • Binocular Vision Disorder
  • Behavioral: Home-based Pencil Push-Up Therapy
  • Behavioral: Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics
  • Behavioral: Office-based Vision Therapy/Orthoptics
  • Behavioral: Placebo Office-based Vision Therapy/Orthoptics
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
221
September 2009
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children between the ages of 9 and 17 years with symptomatic convergence insufficiency
  • Exophoria at near at least 4Δ greater than at far
  • Insufficient positive fusional convergence at near
  • A receded near point of convergence of ≥6 cm break
  • CI Symptom Survey score ≥16

Exclusion Criteria:

  • Previous treatment with office-based vision therapy/orthoptics or pencil push-ups
  • Systemic diseases known to affect accommodation, vergence and ocular motility
  • Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis that in the investigator's discretion would interfere with treatment
Both
9 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338611
Mitchell Scheiman, OD, Pennsylvania College of Optometry
NEI-107
National Eye Institute (NEI)
 
Study Chair: Mitchell Scheiman, OD Pennsylvania College of Optometry
National Eye Institute (NEI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP