| Protocol: | Evaluation of Accommodative Behavior in Children With and Without Amblyopia |
| Status: | Closed |
| Start Date: | 10/12/2018 |
| End Date: | 11/01/2022 |
| Clinical Trial ID: | N/A |
| Public Dataset: |
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Amblyopia Treatment Study 21 (ATS21) - Evaluation of Accommodative Behavior in Children With and Without Amblyopia (Pilot Study)
The proposed pilot study is designed to determine the proportion of amblyopic children with “abnormal” accommodative behavior (amplitude, accuracy, and variability) in the amblyopic eye. The results of this study will allow us to decide whether or not to pursue a future RCT comparing bifocal therapy to single vision lenses in the treatment of amblyopia. The proposed pilot study will determine whether children with amblyopia have significant accommodative behavior deficits, and if so, which accommodative tests should be required for eligibility to maximize enrollment of children with accommodative deficits in any future RCT.
This pilot study is also designed to determine the practicality of using Nott retinoscopy in lieu of “accepted standard” instrument-based methods by determining if Nott retinoscopy has sufficient sensitivity and specificity to detect abnormal accommodative behavior (amplitude, accuracy, and variability) for use in determining eligibility in a future RCT. The proposed pilot study will evaluate three accommodative behaviors (amplitude, accuracy, and variability) using both Nott retinoscopy and the accepted standard instrument-based method for each behavior (Grand Seiko autorefractor for amplitude and accuracy and the Power Ref 3 for variability).
The proposed study also includes secondary analyses to determine differences in accommodative behaviors between the fellow and non-fellow eyes of amblyopic subjects and the best and worst eyes of non-amblyopic subjects. Additionally, we will be able to determine differences in accommodative behavior between the amblyopic eye of the amblyopic subjects and the worse-seeing eye of the non-amblyopic controls, as well as the differences between the fellow eye of amblyopic subjects and the better-seeing eye of the non-amblyopic controls. Additional analyses will also allow us to test the agreement between the Nott retinoscopy method the accepted-standard for each accommodative behavior.
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