Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338611
Status:
UNKNOWN
Last Update Posted:
2010-03-25
First Post:
2006-06-15
Brief Title:
Convergence Insufficiency Treatment Trial CITT
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Convergence Insufficiency Treatment Trial CITT
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of the CITT are
To determine whether Home-based Pencil Push-up therapy Home-based Pencil Push-ups with Computer Vision TherapyOrthoptics or Office-based VTOrthoptics 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
To determine whether Home-based Pencil Push-up therapy Home-based Pencil Push-ups with Computer Vision TherapyOrthoptics or Office-based VTOrthoptics 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
Detailed Description:
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 individuals 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 therapyorthoptics 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 TherapyOrthoptics 3 Office-based Vision TherapyOrthoptics or 4 Placebo Office-based Vision TherapyOrthoptics 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
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 therapyorthoptics 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 TherapyOrthoptics 3 Office-based Vision TherapyOrthoptics or 4 Placebo Office-based Vision TherapyOrthoptics 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None