Clinical trial NCT00347581: A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Convergence Insufficiency
Keywords: convergence insufficiency
base-in prism
orthoptics
vision therapy
Lead sponsor: Pennsylvania College of Optometry
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Eligibility 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.

Primary outcomes:
measure: Symptom score on the Convergence Insufficiency Symptom Survey
Secondary outcomes:
measure: Near point of convergence
measure: Positive fusional vergence at near
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham, College of Optometry
state: Alabama
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Ft. Lauderdale
country: United States
facility: NOVA College of Optometry
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Bloomington
country: United States
facility: Indiana University College of Optometry
state: Indiana
city: New York
country: United States
facility: State University of New York, College of Optometry
state: New York
city: Columbus
country: United States
facility: The Ohio State University, Optometry Coordinating Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Eye Institute, Pennsylvania College of Optometry
state: Pennsylvania
city: Houston
country: United States
facility: University of Houston, College of Optometry
state: Texas
Study officials:
affiliation: Pennsylvania College of Optometry
name: Mitchell Scheiman, OD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.