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NCT04807361 · ClinicalTrials.gov registry record
Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
A clinical trial, sponsored by State University of New York College of Optometry.
- Completed
- Registry status
- 44
- Enrollment target
NCT04807361: Completed study, sponsored by State University of New York College of Optometry.
NCT04807361 is a clinical trial that has completed, run by State University of New York College of Optometry. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04807361 has completed, sponsored by State University of New York College of Optometry.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
Study Summary
This study will examine the accommodative behavior in children undergoing myopia control treatments. A subset of children showing reduced accommodation, known to occur in while wearing multifocal soft contact lenses (MFCL) from previous studies, will undergo auditory biofeedback training to improve the accommodative response and possibly improve treatment efficacy. The results of this study will be used to design a larger clinical trial. Aim 1 - The accommodation response in myopic children being treated with MFCL for six months or longer, will be determined. The accommodative response data will be collected while the patients are wearing the MFCL and will be compared to the baseline control response when the subjects wear single vision soft contact lenses (SVCL). Additional comparisons will include accommodative measures in untreated myopic children wearing spectacle corrections (unttreated controls), children being treated with ortho-keratology contact lenses, and children treated with low-dose atropine (0.01%, considered not to affect accommodation). How these additional myopia treatments affect the accommodation response has yet to be determined. Aim 2 - Children treated with MFCL who show reduced accommodative responses will undergo a brief period of auditory biofeedback accommodative training to determine whether the response in children can be improved and how long it can be sustained. Improving the accommodative response in these patients may improve the treatment efficacy by increasing the effect of the positive power addition built into the lenses.
Primary Outcome
Subjects' accommodative response will be measured using a power refractor
Interventions
- BEHAVIORAL Auditory biofeedback traing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2022-12-12 |
What the finished NCT04807361 record still lists
NCT04807361 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Auditory biofeedback traing is the first listed.
NCT04807361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04807361 about?
NCT04807361 is a clinical study titled "Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)". This study will examine the accommodative behavior in children undergoing myopia control treatments. A subset of children showing reduced accommodation, known to occur in while wearing multifocal soft contact lenses (MFCL) from previous studies, will undergo auditory biofeedback training to improve ...
What is the current status of trial NCT04807361?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2020-12-01. Estimated completion is 2022-12-12.
What interventions are being tested in trial NCT04807361?
The interventions under investigation include: Auditory biofeedback traing (BEHAVIORAL).
Who is sponsoring clinical trial NCT04807361?
This trial is sponsored by State University of New York College of Optometry, which has 14 total clinical trials registered on ClinicalTrials.gov.
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