NCT00347945

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

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

October 1, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

January 1, 2002

First QC Date

July 3, 2006

Last Update Submit

July 3, 2006

Conditions

Convergence Insufficiency

Keywords

convergence insufficiency, vision therapy, orthoptics

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey

Secondary Outcomes (2)

  • Near Point of Convergence

  • Positive Fusional Vergence at Near

Interventions

Pencil Push-upsPROCEDURE
Office-based Vision TherapyPROCEDURE
Placebo Office-based Vision TherapyPROCEDURE

Eligibility Criteria

Age9 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

State University of New York, College of Optometry

New York, New York, 10036, United States

Location

The Ohio State University, Optometry Coordinating Center

Columbus, Ohio, 43210, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Pacific University College of Optometry

Forest Grove, Oregon, 97116, United States

Location

Eye Institute, Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

University of Houston, College of Optometry

Houston, Texas, 77204, United States

Location

Related Publications (6)

  • 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. doi: 10.1097/00006324-200312000-00014.

    PMID: 14688547BACKGROUND

  • 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. doi: 10.1097/00006324-200204000-00013.

    PMID: 11999152BACKGROUND

  • 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. doi: 10.1097/00006324-200203000-00009.

    PMID: 11913841BACKGROUND

  • 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. 2005 Jan;123(1):14-24. doi: 10.1001/archopht.123.1.14.

    PMID: 15642806RESULT

  • 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. 2005 Jul;82(7):583-95. doi: 10.1097/01.opx.0000171331.36871.2f.

    PMID: 16044063RESULT

  • 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

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Mitchell Scheiman, OD

    Pennsylvania College of Optometry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

October 1, 2000

Study Completion

November 1, 2001

Last Updated

July 4, 2006

Record last verified: 2002-01

Locations

US(7)