Clinical trial NCT00315302: Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amblyopia
Keywords: Amblyopia
Atropine
Plano lens
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2006-04-18
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Visual Acuity Mean Score in the Amblyopic Eye
timeFrame: 18 weeks
measure: Visual Acuity Distribution in the Amblyopic Eye
timeFrame: 18 weeks
measure: Mean Change in Visual Acuity in the Amblyopic Eye
timeFrame: baseline to 18 weeks
measure: Distribution of Change in Visual Acuity in the Amblyopic Eye
timeFrame: baseline to 18 weeks
Secondary outcomes:
measure: Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
timeFrame: 18 weeks
measure: Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
timeFrame: 18 weeks
measure: Mean Change in Visual Acuity in the Sound Eye
timeFrame: baseline to 18 weeks
measure: Distribution of Change in Visual Acuity in the Sound Eye
timeFrame: baseline to 18 weeks
measure: Visual Acuity Distribution in the Sound Eye
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: David Weakley, M.D.
role: STUDY_CHAIR
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
name: Susan A. Cotter, O.D.
role: STUDY_CHAIR
References:
citation: Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30. doi: 10.1001/archophthalmol.2008.520.
citation: Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63. doi: 10.1016/j.jaapos.2009.03.002.
citation: Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.
citation: Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.