Convergence Insufficiency Clinical Trial
Official title:
A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
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)
Status | Completed |
Enrollment | 90 |
Est. completion date | November 2001 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Years to 30 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
United States | The Ohio State University, Optometry Coordinating Center | Columbus | Ohio |
United States | Pacific University College of Optometry | Forest Grove | Oregon |
United States | Southern California College of Optometry | Fullerton | California |
United States | University of Houston, College of Optometry | Houston | Texas |
United States | State University of New York, College of Optometry | New York | New York |
United States | Eye Institute, Pennsylvania College of Optometry | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Pennsylvania College of Optometry | National Eye Institute (NEI) |
United States,
Borsting EJ, Rouse MW, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in children aged 9 to 18 years. Optom Vis Sci. 2003 Dec;80(12):832-8. — View Citation
Gallaway M, Scheiman M, Malhotra K. The effectiveness of pencil pushups treatment for convergence insufficiency: a pilot study. Optom Vis Sci. 2002 Apr;79(4):265-7. — View Citation
Scheiman M, Cooper J, Mitchell GL, de LP, Cotter S, Borsting E, London R, Rouse M. A survey of treatment modalities for convergence insufficiency. Optom Vis Sci. 2002 Mar;79(3):151-7. — View Citation
Scheiman M, Mitchell GL, Cotter S, Cooper J, Kulp M, Rouse M, Borsting E, London R, Wensveen J; Convergence Insufficiency Treatment Trial Study Group. A randomized clinical trial of treatments for convergence insufficiency in children. Arch Ophthalmol. 20 — View Citation
Scheiman M, Mitchell GL, Cotter S, Kulp MT, Cooper J, Rouse M, Borsting E, London R, Wensveen J. A randomized clinical trial of vision therapy/orthoptics versus pencil pushups for the treatment of convergence insufficiency in young adults. Optom Vis Sci. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey | |||
Secondary | Near Point of Convergence | |||
Secondary | Positive Fusional Vergence at Near |
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