Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Information source: National Eye Institute (NEI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amblyopia
Intervention: Atropine (Drug); Plano Lens (Device)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Eye Institute (NEI) Official(s) and/or principal investigator(s):
David Weakley, M.D., Study Chair, Affiliation: UT Southwestern Medical Center
Susan A. Cotter, O.D., Study Chair, Affiliation: Southern California College of Optometry
Summary
The purpose of the study is:
- To compare the effectiveness and safety of weekend atropine augmented with a plano lens
for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100)
in children 3 to less than 7 years old.
- To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine
treatment with and without a plano lens.
Clinical Details
Official title: A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Visual acuity for both amblyopic and sound eyes
Detailed description:
Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for
the sound eye is an accepted method of enhancing and possibly accelerating the treatment
effect. Demonstrating additional value of the plano lens in terms of speed of improvement
will shorten the treatment period, possibly improving child and parental compliance, leading
to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater
improvement, then there will be less permanent visual impairment in patients with a history
of amblyopia. It also is important to determine if the use of a plano lens in conjunction
with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.
Little is known about the pharmacologic treatment of severe amblyopia. This study will
provide important prospectively determined outcome data at little additional expense.
In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial
Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend
atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine
use (such as using it only on the weekends) has the theoretical potential benefit of the
sound eye having some time each week during which cycloplegia is only partial. It is possible
that allowing some loss of the cycloplegic effect over the course of each week may be safer
for the sound eye.
The study has been designed as a simple trial that, other than the type of amblyopia therapy
being determined through the randomization process, approximates standard clinical practice.
The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once
each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye
plus a plano lens for the sound eye.
Eligibility
Minimum age: 3 Years.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must be 3 to less than 7 years old with amblyopia associated with strabismus,
anisometropia, or both.
- Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual
acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR
lines.
- Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity
documented to be stable.
Exclusion Criteria:
- Atropine treatment within 6 months of enrollment and other amblyopia treatment of any
type (other than normal spectacle lenses) used within one month of enrollment
- No myopia in amblyopic eye
Locations and Contacts
Southern California College of Optometry, Fullerton, California 92831, United States
UT Southwestern Medical Center, Dallas, Texas 75235, United States
Additional Information
NEI Clinical Studies Database PEDIG public website
Starting date: February 2005
Ending date: January 2008
Last updated: December 21, 2007
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