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Convergence Insufficiency Treatment Trial (CITT)

Primary Purpose

Convergence Insufficiency, Binocular Vision Disorder

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Home-based Pencil Push-Up Therapy
Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics
Office-based Vision Therapy/Orthoptics
Placebo Office-based Vision Therapy/Orthoptics
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convergence Insufficiency focused on measuring vision therapy, orthoptics, pencil push-up therapy

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham School of Optometry
  • Southern California College of Optometry
  • Ratner Children's Eye Center
  • NOVA Southeastern University College of Optometry
  • Bascom Palmer Eye Institute
  • Mayo Clinic
  • State University of New York College of Optometry
  • The Ohio State University College of Optometry
  • Pennsylvania College of Optometry

Outcomes

Primary Outcome Measures

Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey

Secondary Outcome Measures

Eyes' ability to converge when performing close work

Full Information

First Posted
June 15, 2006
Last Updated
March 24, 2010
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00338611
Brief Title
Convergence Insufficiency Treatment Trial (CITT)
Official Title
Convergence Insufficiency Treatment Trial (CITT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convergence Insufficiency, Binocular Vision Disorder
Keywords
vision therapy, orthoptics, pencil push-up therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Home-based Pencil Push-Up Therapy
Intervention Description
Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose
Intervention Type
Behavioral
Intervention Name(s)
Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Office-based Vision Therapy/Orthoptics
Intervention Description
Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
Intervention Type
Behavioral
Intervention Name(s)
Placebo Office-based Vision Therapy/Orthoptics
Intervention Description
Vision activities designed to simulate office-based therapy
Primary Outcome Measure Information:
Title
Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Eyes' ability to converge when performing close work
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Scheiman, OD
Organizational Affiliation
Pennsylvania College of Optometry
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham School of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Ratner Children's Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
NOVA Southeastern University College of Optometry
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
State University of New York College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pennsylvania College of Optometry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18852411
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.
Results Reference
result
PubMed Identifier
33263359
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.
Results Reference
derived
PubMed Identifier
31651593
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.
Results Reference
derived
PubMed Identifier
22922781
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.
Results Reference
derived
PubMed Identifier
20543758
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.
Results Reference
derived
PubMed Identifier
19741558
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.
Results Reference
derived
PubMed Identifier
19668097
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.
Results Reference
derived
PubMed Identifier
19151384
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.
Results Reference
derived
Links:
URL
http://www.nei.nih.gov/health/clinicalstudies/
Description
NEI Clinical Studies Database

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Convergence Insufficiency Treatment Trial (CITT)

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