Clinical trial NCT00338611: Convergence Insufficiency Treatment Trial (CITT)
Official title: Convergence Insufficiency Treatment Trial (CITT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Convergence Insufficiency
Binocular Vision Disorder
Keywords: vision therapy
orthoptics
pencil push-up therapy
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
First posted: 2006-06-20
Enrollment: 221
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of the CITT are:

* 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.

Detailed description: Convergence insufficiency is a prevalent and distinct binocular vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. It affects approximately 5% of children in the United States, and may have a serious impact on an individual's performance in school, choice of jobs, and quality of life.

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.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 9 and 17 years with symptomatic convergence insufficiency
* 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:

* Previous treatment with office-based vision therapy/orthoptics or pencil push-ups
* 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

Primary outcomes:
measure: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey
timeFrame: 12 weeks
Secondary outcomes:
measure: Eyes' ability to converge when performing close work
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Optometry
state: Alabama
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: La Jolla
country: United States
facility: Ratner Children's Eye Center
state: California
city: Ft. Lauderdale
country: United States
facility: NOVA Southeastern University College of Optometry
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: State University of New York College of Optometry
state: New York
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania College of Optometry
state: Pennsylvania
Study officials:
affiliation: Pennsylvania College of Optometry
name: Mitchell Scheiman, OD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.