Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects
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Device: Multifocal soft contact lens wear for myopia control
Subjects will be wearing MFCLs for myopia control, and their accommodative responses to various demands (0, 2.5, 3, and 4 D) will be measured using a power refractor.
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Outcome Measures
Primary Outcome Measures
- Accommodation [Within 4 weeks]
Subjects' accommodative response will be measured using a power refractor
Eligibility Criteria
Criteria
Inclusion Criteria:
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Best corrected monocular Snellen visual acuity (VA) ≧ 20/25
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Age 8 - 15 years
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Refractive error spherical equivalent between -0.75 D and -10 D
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Astigmatism ≤ 0.75 D
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Age-appropriate amplitude of accommodation
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No suspected or confirmed eye disease (anamnesis)
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No accommodative or binocular function abnormalities
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Agreement to participate in the study (informed consent of parents, assent of child)
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Children who are currently under myopia control treatment should already be so for ≥ 6 months
Exclusion Criteria:
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Persons who are incapable of giving consent
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Refractive error spherical equivalent < -10 D and > -0.75 D
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Astigmatism > 0.75 D
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Abnormal binocular functions
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Medication affecting accommodative response or causing dry eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | State University of New York, College of Optometry | Long Beach | New York | United States | 11561 |
Sponsors and Collaborators
- State University of New York College of Optometry
- University Hospital Tuebingen
Investigators
- Study Director: Stewart Bloomfield, PhD, State University of New York College of Optometry
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRBNET ID 1525840