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Convergence InsufficiencyPhase 3NCT00347945

Randomized Trial of Treatments for Convergence Insufficiency

A Phase 3 study testing Pencil Push-ups and Office-based Vision Therapy in people with Convergence Insufficiency, run by Pennsylvania College of Optometry at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 9 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Convergence Insufficiency
What is being tested?
Pencil Push-ups and Office-based Vision Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
7 sitesUnited States
Study dates
Oct 2000to Nov 2001
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • The Ohio State University, Optometry Coordinating Center

    Columbus, Ohio, 43210

  • The Ohio State University

    Columbus, Ohio, 43210

  • Pacific University College of Optometry

    Forest Grove, Oregon, 97116

  • Southern California College of Optometry

    Fullerton, California, 92831

  • University of Houston, College of Optometry

    Houston, Texas, 77204

  • State University of New York, College of Optometry

    New York, New York, 10036

  • Eye Institute, Pennsylvania College of Optometry

    Philadelphia, Pennsylvania, 19141

Other trials in United States

About this study

Official title: A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency

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)

Read the detailed description

Considerable controversy exists regarding the best treatment for convergence insufficiency (CI), a common condition that often interferes with the ability to perform near work. The two most widely used treatments have significant differences in costs and in practitioner perceived utility. Pencil push-up therapy (PPT) is a simple, low-cost treatment in which patients are prescribed a single procedure to perform at home with only periodic follow-up. Office-based vision therapy (OBVT) is a more comprehensive, time-consuming, complex, and costly treatment in which patients are scheduled for weekly in-office therapy visits and are often prescribed a specific sequence of therapeutic procedures to perform at home. It is important to consider whether either, neither, or both treatments are effective.

The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked-examiner, multi-center clinical trial in which patients are randomized to one of these two treatment approaches. The primary goal is to answer the following question:

After 12 weeks of treatment, is one therapy more effective than the other in improving CI signs and symptoms? We will test the null hypothesis that there is no difference in the distribution of outcomes between the two populations.

The primary outcome measure will be a classification of each patient as a "success," "improvement," or "failure." This classification will be based on the level of improvement in both the signs (near point of convergence and positive fusional vergence) and symptoms of CI.

Additional questions relate to longer term effects:

  1. Are the patients who were classified as "success" or "improvement" at twelve weeks the same at the one-year follow-up for each treatment group?
  2. Are there differences in the distributions of changes in near point of convergence, positive fusional vergence, or accommodative amplitudes, between the two treatment groups, at twelve weeks and at one-year of follow up?
Being tested
Pencil Push-ups, Office-based Vision Therapy, Placebo Office-based Vision Therapy
Keywords
convergence insufficiency, vision therapy, orthoptics
Medical subject headings
Ocular Motility Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pencil Push-upsProcedure or surgery

  • Office-based Vision TherapyProcedure or surgery

  • Placebo Office-based Vision TherapyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

  1. Near Point of Convergence

  2. Positive Fusional Vergence at Near

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2006 (estimated)
  2. Study startOct 2000
  3. Study completionNov 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00347945
Sponsor's protocol ID
HMS2040
Other IDs
1R21EY13164-1, 1R21EY013164
Status last verified
Jan 2002
First submitted
3 Jul 2006
Last updated
4 Jul 2006
Results posted
No

Publications

  • 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.

    PubMed 14688547

  • 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.

    PubMed 11999152

  • 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.

    PubMed 11913841

  • 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.

    PubMed 15642806

  • 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.

    PubMed 16044063

  • 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.

    PubMed 33263359

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pencil Push-ups and Office-based Vision Therapy in people with Convergence Insufficiency, run by Pennsylvania College of Optometry at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00347945, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2006.

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