NCT00338611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
221

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 25, 2010

Status Verified

October 1, 2008

Enrollment Period

3.2 years

First QC Date

June 15, 2006

Last Update Submit

March 24, 2010

Conditions

Convergence InsufficiencyBinocular Vision Disorder

Keywords

vision therapyorthopticspencil push-up therapy

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (1)

  • Eyes' ability to converge when performing close work

    12 weeks

Interventions

Home-based Pencil Push-Up TherapyBEHAVIORAL

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/OrthopticsBEHAVIORAL

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/OrthopticsBEHAVIORAL

Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises

Placebo Office-based Vision Therapy/OrthopticsBEHAVIORAL

Vision activities designed to simulate office-based therapy

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham School of Optometry

Birmingham, Alabama, 35294, United States

Location

Southern California College of Optometry

Fullerton, California, 92093, United States

Location

Ratner Children's Eye Center

La Jolla, California, 92093, United States

Location

NOVA Southeastern University College of Optometry

Fort Lauderdale, Florida, 33328, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

State University of New York College of Optometry

New York, New York, 10036, United States

Location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (8)

  • 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.

    PMID: 18852411RESULT

  • 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.

    PMID: 33263359DERIVED

  • 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.

    PMID: 31651593DERIVED

  • 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.

    PMID: 22922781DERIVED

  • 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.

    PMID: 20543758DERIVED

  • 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.

    PMID: 19741558DERIVED

  • 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.

    PMID: 19668097DERIVED

  • 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.

    PMID: 19151384DERIVED

MeSH Terms

Conditions

Ocular Motility Disorders

Interventions

Orthoptics

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mitchell Scheiman, OD

    Pennsylvania College of Optometry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

July 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2009

Last Updated

March 25, 2010

Record last verified: 2008-10

Locations

US(9)