A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
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ClinicalTrials.gov Identifier: NCT00347581 |
Recruitment Status :
Completed
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Convergence Insufficiency | Procedure: Base-in prism glasses for reading Procedure: Placebo reading glasses | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2003 |
Study Completion Date : | August 2004 |
- Symptom score on the Convergence Insufficiency Symptom Survey
- Near point of convergence
- Positive fusional vergence at near

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 9 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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 .
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347581
United States, Alabama | |
University of Alabama, Birmingham, College of Optometry | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Southern California College of Optometry | |
Fullerton, California, United States, 92831 | |
United States, Florida | |
NOVA College of Optometry | |
Ft. Lauderdale, Florida, United States, 33328 | |
Bascom Palmer Eye Institute | |
Miami, Florida, United States, 33136 | |
United States, Indiana | |
Indiana University College of Optometry | |
Bloomington, Indiana, United States, 47405 | |
United States, New York | |
State University of New York, College of Optometry | |
New York, New York, United States, 10036 | |
United States, Ohio | |
The Ohio State University, Optometry Coordinating Center | |
Columbus, Ohio, United States, 43210 | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Eye Institute, Pennsylvania College of Optometry | |
Philadelphia, Pennsylvania, United States, 19141 | |
United States, Texas | |
University of Houston, College of Optometry | |
Houston, Texas, United States, 77204 |
Study Chair: | Mitchell Scheiman, OD | Pennsylvania College of Optometry |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00347581 |
Other Study ID Numbers: |
hms0304 |
First Posted: | July 4, 2006 Key Record Dates |
Last Update Posted: | July 4, 2006 |
Last Verified: | January 2005 |
convergence insufficiency base-in prism orthoptics vision therapy |
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