Convergence InsufficiencyPhase 3NCT00347581
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
A Phase 3 study testing Base-in prism glasses for reading in people with Convergence Insufficiency, run by Pennsylvania College of Optometry at 10 sites in United States.
Trial summary
This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Base-in prism glasses for reading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2003to Aug 2004
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 9 to <19 years.
- Best corrected visual acuity of ≥20/25 in each eye at distance and near
- Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
- Willingness to wear glasses for reading and other near work
- Exophoria at near at least 4 greater than at far
- Insufficient positive fusional convergence (fails Sheard's criterion)
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- Receded near point of convergence of 6 cm break
- Random dot stereopsis appreciation using a 500 seconds of arc target.
- CI Symptom Survey score 16
Who cannot join
- Amblyopia (> 2 line difference in best corrected visual acuity between the two eyes).
- Constant strabismus
- History of strabismus surgery.
- Anisometropia 2D in any meridian between the eyes.
- Prior refractive surgery.
- Vertical heterophoria greater than 1 .
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- Systemic diseases known to affect accommodation, vergence and ocular motility such as: multiple sclerosis, Graves thyroid disease, myasthenia gravis, diabetes, Parkinson disease.
- Any ocular or systemic medication known to affect accommodation or vergence (Anti-anxiety agents (Librium or Valium), Anti-arrhythmic agents (Cifenline or Cibenzoline), Anticholinergics (Motion sickness patch (scopolamine), Bladder spasmolytic drugs (Propiverine), Chloroquine, Phenothiazines (Compazine, Mellaril, or Thorazine), Tricyclic antidepressants (Elavil, Nortriptyline, or Tofranil)
- Accommodative amplitude <5 D in either eye as measured by the Donder's push-up method.
- Manifest or latent nystagmus.
- Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with treatment.
- Household member or sibling already enrolled in the BI-CITT.
- Any eye care professional, ophthalmic technician, ophthalmology or optometry resident or optometry student.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama, Birmingham, College of Optometry
Birmingham, Alabama, 35294
Indiana University College of Optometry
Bloomington, Indiana, 47405
The Ohio State University, Optometry Coordinating Center
Columbus, Ohio, 43210
The Ohio State University
Columbus, Ohio, 43210
NOVA College of Optometry
Fort Lauderdale, Florida, 33328
Southern California College of Optometry
Fullerton, California, 92831
University of Houston, College of Optometry
Houston, Texas, 77204
Bascom Palmer Eye Institute
Miami, Florida, 33136
State University of New York, College of Optometry
New York, New York, 10036
Eye Institute, Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141
About this study
Official title: A Randomized Clinical Trial of the Effectiveness of Base-in Prism Reading Glasses Vs. Placebo Reading Glasses for Symptomatic Convergence Insufficiency in Children
This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.
Read the detailed description
The Base-in for Convergence Insufficiency Treatment Trial (BI-CITT) is a multi-center, placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism for patients with convergence insufficiency (CI).
The goals of this clinical trial are:
- To compare the effectiveness of Base-in prism and Placebo eyeglasses for the treatment of CI in children
- To study the long-term effect of these treatments for CI
- To identify factors that may be associated with successful treatment of CI with base-in prism
- Conditions
- Convergence Insufficiency
- Being tested
- Base-in prism glasses for reading, Placebo reading glasses
- Keywords
- convergence insufficiency, base-in prism, orthoptics, vision 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.
Base-in prism glasses for readingProcedure or surgery
Placebo reading glassesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score on the Convergence Insufficiency Symptom Survey
Secondary outcomes (2)
Near point of convergence
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.
- First posted4 Jul 2006 (estimated)
- Study startMay 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Convergence InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- Pennsylvania College of Optometry
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mitchell Scheiman, OD, Study chair, Pennsylvania College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347581
- Sponsor's protocol ID
- hms0304
- Status last verified
- Jan 2005
- First submitted
- 3 Jul 2006
- Last updated
- 4 Jul 2006
- Results posted
- No
Publications
Scheiman M, Cotter S, Rouse M, Mitchell GL, Kulp M, Cooper J, Borsting E; Convergence Insufficiency Treatment Trial Study Group. Randomised clinical trial of the effectiveness of base-in prism reading glasses versus placebo reading glasses for symptomatic convergence insufficiency in children. Br J Ophthalmol. 2005 Oct;89(10):1318-23. doi: 10.1136/bjo.2005.068197.
PubMed 16170124Scheiman 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of the Effectiveness of Base-in Prism Reading Glasses Vs. Placebo Reading Glasses for Symptomatic Convergence Insufficiency in Children
- ClinicalTrials.gov ID
- NCT00347581
- Acronym / sponsor ID
- hms0304
- Conditions
- Convergence Insufficiency
- Keywords
- convergence insufficiency, base-in prism, orthoptics, vision therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- Pennsylvania College of OptometryIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Aug 2004
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.
Detailed description
The Base-in for Convergence Insufficiency Treatment Trial (BI-CITT) is a multi-center, placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism for patients with convergence insufficiency (CI).
The goals of this clinical trial are:
- To compare the effectiveness of Base-in prism and Placebo eyeglasses for the treatment of CI in children
- To study the long-term effect of these treatments for CI
- To identify factors that may be associated with successful treatment of CI with base-in prism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age: 9 to <19 years.
- Best corrected visual acuity of ≥20/25 in each eye at distance and near
- Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
- Willingness to wear glasses for reading and other near work
- Exophoria at near at least 4 greater than at far
Key exclusion criteria (13 listed)
- Amblyopia (> 2 line difference in best corrected visual acuity between the two eyes).
- Constant strabismus
- History of strabismus surgery.
- Anisometropia 2D in any meridian between the eyes.
- Prior refractive surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Base-in prism glasses for reading | Procedure or surgery | – |
| Placebo reading glasses | Procedure or surgery | – |
Primary outcome
Symptom score on the Convergence Insufficiency Symptom Survey
2 secondary outcomes
Near point of convergence
Positive fusional vergence at near
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2006.
- Results publication: PubMed 16170124Scheiman M, Cotter S, Rouse M, Mitchell GL, Kulp M, Cooper J, Borsting E; Convergence Insufficiency Treatment Trial Study Group. Randomised clinical trial of the effectiveness of base-in prism reading glasses versus placebo reading glasses for symptomatic convergence insufficiency in children. Br J Ophthalmol. 2005 Oct;89(10):1318-23. doi: 10.1136/bjo.2005.068197.
- Derived from this study: PubMed 33263359Scheiman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Scheiman, OD study chair
Pennsylvania College of Optometry
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Base-in prism glasses for reading in people with Convergence Insufficiency, run by Pennsylvania College of Optometry at 10 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 13 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 10 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?
Symptom 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 NCT00347581, which also lists 2 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.