Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347945
Status:
COMPLETED
Last Update Posted:
2006-07-04
First Post:
2006-07-03
Brief Title:
Randomized Trial of Treatments for Convergence Insufficiency
Sponsor:
Pennsylvania College of Optometry
Organization:
Pennsylvania College of Optometry
Study Overview
Official Title:
A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
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 Convergence Insufficiency Treatment Trial CITT is a multi-center placebo-controlled single-masked clinical trial designed to compare the benefits of two commonly used treatment approaches for patients with convergence insufficiency CI
Detailed Description:
Considerable controversy exists regarding the best treatment for convergence insufficiency CI a common condition that often interferes with the ability to perform near work The two most widely used treatments have significant differences in costs and in practitioner perceived utility Pencil push-up therapy PPT is a simple low-cost treatment in which patients are prescribed a single procedure to perform at home with only periodic follow-up Office-based vision therapy OBVT is a more comprehensive time-consuming complex and costly treatment in which patients are scheduled for weekly in-office therapy visits and are often prescribed a specific sequence of therapeutic procedures to perform at home It is important to consider whether either neither or both treatments are effective
The Convergence Insufficiency Treatment Trial CITT is a prospective masked-examiner multi-center clinical trial in which patients are randomized to one of these two treatment approaches The primary goal is to answer the following question
After 12 weeks of treatment is one therapy more effective than the other in improving CI signs and symptoms We will test the null hypothesis that there is no difference in the distribution of outcomes between the two populations
The primary outcome measure will be a classification of each patient as a success improvement or failure This classification will be based on the level of improvement in both the signs near point of convergence and positive fusional vergence and symptoms of CI
Additional questions relate to longer term effects
1 Are the patients who were classified as success or improvement at twelve weeks the same at the one-year follow-up for each treatment group
2 Are there differences in the distributions of changes in near point of convergence positive fusional vergence or accommodative amplitudes between the two treatment groups at twelve weeks and at one-year of follow up
The Convergence Insufficiency Treatment Trial CITT is a prospective masked-examiner multi-center clinical trial in which patients are randomized to one of these two treatment approaches The primary goal is to answer the following question
After 12 weeks of treatment is one therapy more effective than the other in improving CI signs and symptoms We will test the null hypothesis that there is no difference in the distribution of outcomes between the two populations
The primary outcome measure will be a classification of each patient as a success improvement or failure This classification will be based on the level of improvement in both the signs near point of convergence and positive fusional vergence and symptoms of CI
Additional questions relate to longer term effects
1 Are the patients who were classified as success or improvement at twelve weeks the same at the one-year follow-up for each treatment group
2 Are there differences in the distributions of changes in near point of convergence positive fusional vergence or accommodative amplitudes between the two treatment groups at twelve weeks and at one-year of follow up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21EY13164-1 | None | None | None |