Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
221 participants
INTERVENTIONAL
2005-07-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency
NCT02207517
Neural Mechanism of Vision Therapy for Patients With Convergence Insufficiency
NCT03593031
Screening for Convergence Insufficiency in School-age Children
NCT00472407
The Effectiveness of Visual Training in Convergence Insufficiency Patients
NCT05603962
Study of Binocular Computer Activities for Treatment of Amblyopia
NCT02200211
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 therapy/orthoptics. 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 Therapy/Orthoptics, 3) Office-based Vision Therapy/Orthoptics, or 4) Placebo Office-based Vision Therapy/Orthoptics. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Home-based Pencil Push-Up Therapy
Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose
Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics
Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose combined with additional computer vision therapy
Office-based Vision Therapy/Orthoptics
Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
Placebo Office-based Vision Therapy/Orthoptics
Vision activities designed to simulate office-based therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Exophoria at near at least 4Δ greater than at far
* Insufficient positive fusional convergence at near
* A receded near point of convergence of ≥6 cm break
* CI Symptom Survey score ≥16
Exclusion Criteria
* Systemic diseases known to affect accommodation, vergence and ocular motility
* Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis that in the investigator's discretion would interfere with treatment
9 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Eye Institute (NEI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pennsylvania College of Optometry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mitchell Scheiman, OD
Role: STUDY_CHAIR
Pennsylvania College of Optometry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham School of Optometry
Birmingham, Alabama, United States
Southern California College of Optometry
Fullerton, California, United States
Ratner Children's Eye Center
La Jolla, California, United States
NOVA Southeastern University College of Optometry
Fort Lauderdale, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
State University of New York College of Optometry
New York, New York, United States
The Ohio State University College of Optometry
Columbus, Ohio, United States
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336.
Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
CITT-ART Investigator Group. Treatment of Symptomatic Convergence Insufficiency in Children Enrolled in the Convergence Insufficiency Treatment Trial-Attention & Reading Trial: A Randomized Clinical Trial. Optom Vis Sci. 2019 Nov;96(11):825-835. doi: 10.1097/OPX.0000000000001443.
Barnhardt C, Cotter SA, Mitchell GL, Scheiman M, Kulp MT; CITT Study Group. Symptoms in children with convergence insufficiency: before and after treatment. Optom Vis Sci. 2012 Oct;89(10):1512-20. doi: 10.1097/OPX.0b013e318269c8f9.
Scheiman M, Kulp MT, Cotter S, Mitchell GL, Gallaway M, Boas M, Coulter R, Hopkins K, Tamkins S; Convergence Insufficiency Treatment Trial Study Group. Vision therapy/orthoptics for symptomatic convergence insufficiency in children: treatment kinetics. Optom Vis Sci. 2010 Aug;87(8):593-603. doi: 10.1097/OPX.0b013e3181e61bad.
Rouse M, Borsting E, Mitchell GL, Kulp MT, Scheiman M, Amster D, Coulter R, Fecho G, Gallaway M; CITT Study Group. Academic behaviors in children with convergence insufficiency with and without parent-reported ADHD. Optom Vis Sci. 2009 Oct;86(10):1169-77. doi: 10.1097/OPX.0b013e3181baad13.
Convergence Insufficiency Treatment Trial Study Group. Long-term effectiveness of treatments for symptomatic convergence insufficiency in children. Optom Vis Sci. 2009 Sep;86(9):1096-103. doi: 10.1097/OPX.0b013e3181b6210f.
Kulp M, Mitchell GL, Borsting E, Scheiman M, Cotter S, Rouse M, Tamkins S, Mohney BG, Toole A, Reuter K; Convergence Insufficiency Treatment Trial Study Group. Effectiveness of placebo therapy for maintaining masking in a clinical trial of vergence/accommodative therapy. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2560-6. doi: 10.1167/iovs.08-2693. Epub 2009 Jan 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEI-107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.