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Convergence InsufficiencyPhase 3NCT00338611

Convergence Insufficiency Treatment Trial (CITT)

A Phase 3 study testing Home-based Pencil Push-Up Therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics and Office-based Vision Therapy/Orthoptics in people with Convergence Insufficiency and Binocular Vision Disorder, run by National Eye Institute (NEI) at 9 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 9 to 18 years
What is being tested?
Home-based Pencil Push-Up Therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics and Office-based Vision Therapy/Orthoptics
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
9 sitesUnited States
Study dates
Jul 2005to Sep 2009
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Alabama at Birmingham School of Optometry

    Birmingham, Alabama, 35294

  • The Ohio State University College of Optometry

    Columbus, Ohio, 43210

  • NOVA Southeastern University College of Optometry

    Fort Lauderdale, Florida, 33328

  • Southern California College of Optometry

    Fullerton, California, 92093

  • Ratner Children's Eye Center

    La Jolla, California, 92093

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • State University of New York College of Optometry

    New York, New York, 10036

  • Pennsylvania College of Optometry

    Philadelphia, Pennsylvania, 19141

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.
Read the 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.

Being tested
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
Keywords
vision therapy, orthoptics, pencil push-up therapy
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.

  • Home-based Pencil Push-Up TherapyBehavioural

    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/OrthopticsBehavioural

    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/OrthopticsBehavioural

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

  • Placebo Office-based Vision Therapy/OrthopticsBehavioural

    Vision activities designed to simulate office-based therapy

What is being measured

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

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

    Measured: 12 weeks

Secondary outcomes (1)

  1. Eyes' ability to converge when performing close work

    Measured: 12 weeks

Timeline

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

  1. First posted20 Jun 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionSep 2008
  4. Study completionSep 2009 (estimated)

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338611
Sponsor's protocol ID
NEI-107
Status last verified
Oct 2008
First submitted
15 Jun 2006
Last updated
25 Mar 2010
Results posted
No

Publications

  • 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.

    PubMed 18852411

  • 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

  • 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.

    PubMed 31651593

  • 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.

    PubMed 22922781

  • 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.

    PubMed 20543758

  • 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.

    PubMed 19741558

  • 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.

    PubMed 19668097

  • 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.

    PubMed 19151384

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Home-based Pencil Push-Up Therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics and Office-based Vision Therapy/Orthoptics in people with Convergence Insufficiency and Binocular Vision Disorder, run by National Eye Institute (NEI) at 9 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Results are not available in the source record.

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?

Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey (time frame: 12 weeks). 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 NCT00338611, which also lists 8 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 25 Mar 2010.

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