Status:
COMPLETED
Randomized Trial of Treatments for Convergence Insufficiency
Lead Sponsor:
Pennsylvania College of Optometry
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Convergence Insufficiency
Eligibility:
All Genders
9-30 years
Phase:
PHASE3
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...
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 use...
Eligibility Criteria
Inclusion
- Age 9-30 years
- Best corrected visual acuity of 20/25 in both eyes at distance and near
- Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
- Exophoria at near at least 4 prism diopters greater than at far
- Insufficient positive fusional convergence (i.e., failing Sheard's criterion or minimum normative positive fusional vergence (PFV) of 15 base-out break).
- Receded near point of convergence of \> 6 cm break.
- Normal random dot stereopsis using a 500 seconds of arc target.
- CI Symptom Survey score \> 16 for subjects in 9-18 year age range and \> 21 for subjects in the 19-30 year age range.
- Informed consent and willingness to participate in the study and be randomized
Exclusion
- CI previously treated with pencil push-ups (no more than 2 months of treatment within the past year)
- CI previously treated with office-based vision therapy/orthoptics (no more than 2 months of treatment within the past year)
- Amblyopia
- Constant strabismus
- History of strabismus surgery
- Anisometropia \>1.50D difference between eyes
- Prior refractive surgery
- Vertical heterophoria greater than 1
- Systemic diseases known to affect accommodation, vergence, and ocular motility such as: multiple sclerosis, Graves's thyroid disease, myasthenia gravis, diabetes, and Parkinson disease
- Any ocular or systemic medication known to affect accommodation or vergence
- Monocular accommodative amplitude less than 4 D in either eye as measured by the Donder's push-up method
- Manifest or latent nystagmus
- Attention deficit hyperactivity disorder (ADHD) or learning disability diagnosis by parental report
- Household member or sibling already enrolled in the CITT
- Any eye care professional, technician, medical student, or optometry student
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2001
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00347945
Start Date
October 1 2000
End Date
November 1 2001
Last Update
July 4 2006
Active Locations (7)
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1
Southern California College of Optometry
Fullerton, California, United States, 92831
2
State University of New York, College of Optometry
New York, New York, United States, 10036
3
The Ohio State University, Optometry Coordinating Center
Columbus, Ohio, United States, 43210
4
The Ohio State University
Columbus, Ohio, United States, 43210