Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old (ATS13)
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|ClinicalTrials.gov Identifier: NCT00669539|
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : May 21, 2012
Last Update Posted : July 13, 2016
|Condition or disease|
This study will evaluate the effectiveness of refractive correction alone for the treatment of previously untreated strabismic or combined-mechanism amblyopia in children 3 to <7 years old with visual acuity of 20/40 to 20/400.
A recently completed PEDIG study (ATS5) found that in 3 to < 7-year-old children with previously untreated anisometropic amblyopia, refractive correction alone improved visual acuity by 2 or more lines in 77% of the patients and amblyopia resolved in at least one third of the patients. These results supported previous observations from retrospective and pilot studies as well as Stewart et al's prospective report on 18 children with anisometropic amblyopia whose visual acuity improved after treatment with spectacle correction only.
Improvement in amblyopic eye visual acuity from treatment with optimum refractive correction in cases of anisometropic amblyopia is plausible because the refractive correction treats the underlying amblyogenic condition (i.e., uncorrected unequal refractive error) by providing retinal images of more similar clarity, size, and contrast. Elimination of the dissimilar retinal images, which may act as barriers to normal visual input, allows the amblyopic eye to receive appropriate visual stimulation. In contrast, visual acuity improvement with refractive correction alone in cases of amblyopia associated with strabismus is not expected to occur when the refractive correction does not completely eliminate the strabismus and restore fusion. In such cases, the underlying amblyogenic factor of a manifest ocular deviation remains; consequently, active cortical inhibition is presumably still present. Nonetheless, Stewart and colleagues recently reported finding gains in amblyopic eye visual acuity of children with strabismic and combined-mechanism amblyopia after a period of treatment with refractive correction alone. The PEDIG also observed this to occur in a subgroup of children with previously untreated strabismic and combined-mechanism amblyopia in a recent study. Amblyopic eye acuity improved by >= 2 lines from spectacle-corrected baseline acuity in 9 (75%; 95% CI = 43% - 95%) of the 12 patients with strabismic amblyopia and in 9 (69%, 95% CI = 39% - 91%) of the 13 patients with combined-mechanism amblyopia. Mean change from baseline to maximum improvement was 2.2 +- 1.8 and 2.6 +- 2.0 lines, respectively. These results are similar to those of Stewart and colleagues who reported visual acuity improvement averaging 3.0 lines in 16 children with strabismic amblyopia and 1.9 lines in 31 children with combined-mechanism amblyopia.
Although our results support the suggestion of Stewart et al. that strabismic amblyopia can improve with spectacle correction alone, they are not conclusive because both studies had small numbers of patients. Also, our classification of strabismus was based on alignment without refractive correction. Thus, a larger controlled study is needed to confirm or refute these findings in patients with strabismic and combined-mechanism amblyopia.
The ideal study design to answer the question of whether spectacles alone can significantly improve amblyopic eye visual acuity in strabismic children is a randomized trial with a control group who does not receive optical correction. However, most pediatric eye care providers would be reluctant to randomize esotropic children with hyperopic refractive error to a control group of no optical correction because of the likelihood of some children having accommodative esotropia, which would necessitate that hyperopic spectacles be prescribed. The number of esotropic amblyopes without an accommodative component is sufficiently few to make a randomized trial not feasible. Therefore, we have chosen to perform an observational study with a large number of children with pure strabismic and combined-mechanism amblyopia in order to evaluate the effect of refractive correction in this population of patients.
|Study Type :||Observational|
|Actual Enrollment :||156 participants|
|Official Title:||An Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||December 2010|
- Mean Amblyopic Eye Visual Acuity Improvement With Spectacles [ Time Frame: Enrollment to 18 Weeks ]Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
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): NCT00669539
|United States, California|
|Southern California College of Optometry|
|Fullerton, California, United States, 92831-1699|
|Study Chair:||Susan A. Cotter, O.D., M.S.||Southern California College of Optometry at Marshall B. Ketchum University|