A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
This study has been completed.
Sponsor:
Pennsylvania College of Optometry
Information provided by:
Pennsylvania College of Optometry
ClinicalTrials.gov Identifier:
NCT00347581
First received: July 3, 2006
Last updated: NA
Last verified: January 2005
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Convergence Insufficiency |
Procedure: Base-in prism glasses for reading Procedure: Placebo reading glasses |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Pennsylvania College of Optometry:
Primary Outcome Measures:
- Symptom score on the Convergence Insufficiency Symptom Survey
Secondary Outcome Measures:
- Near point of convergence
- Positive fusional vergence at near
| Estimated Enrollment: | 72 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | August 2004 |
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
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347581
Locations
| 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 | |
| Columbus, Ohio, United States, 43210 | |
| The Ohio State University, Optometry Coordinating Center | |
| 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 | |
Sponsors and Collaborators
Pennsylvania College of Optometry
Investigators
| Study Chair: | Mitchell Scheiman, OD | Pennsylvania College of Optometry |
More Information
Additional Information:
Study Website 
Publications:
| ClinicalTrials.gov Identifier: | NCT00347581 History of Changes |
| Other Study ID Numbers: | hms0304 |
| Study First Received: | July 3, 2006 |
| Last Updated: | July 3, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pennsylvania College of Optometry:
|
convergence insufficiency base-in prism orthoptics vision therapy |
Additional relevant MeSH terms:
|
Ocular Motility Disorders Central Nervous System Diseases Nervous System Diseases Cranial Nerve Diseases Eye Diseases Methamphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013