Randomized Trial of Treatments for Convergence Insufficiency

Completed · Phase 3 · Has a placebo group

Conditions studied: Convergence Insufficiency

In brief

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)

Key facts

Study ID

NCT00347945

Run by

Pennsylvania College of Optometry

People needed

90

Starts

2000-10-01

Expected to finish

2001-11-01

Last updated by the study team

2006-07-04

Who can join

Age: 9 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern California College of Optometry — Fullerton, California, United States
• State University of New York, College of Optometry — New York, New York, United States
• The Ohio State University, Optometry Coordinating Center — Columbus, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Pacific University College of Optometry — Forest Grove, Oregon, United States
• Eye Institute, Pennsylvania College of Optometry — Philadelphia, Pennsylvania, United States
• University of Houston, College of Optometry — Houston, Texas, United States

Full record on ClinicalTrials.gov

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