Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
NCT ID: NCT04807361
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2020-12-01
2022-12-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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(1) Multifocal soft contact lenses (MFCLs)
Assess accommodative function of myopic children wearing MFCLs for myopia control treatment. Accommodative stimulus-response functions and accommodative lags will be determined during one, one hour measurement session for four stimulus distances using an IR video refractometer (PowerRefractor). MFCL subjects will also be tested while wearing SVCL distance corrections for comparison.
Auditory biofeedback traing
Subjects who wear MFCLs for myopia control will receive one episode of auditory biofeedback training, and their accommodative responses to various demands (0, 2.5, 3, and 4 D) before and after the training were measured using a power refractor.
(2) orthokeratology
Assess accommodative function of myopic children wearing Orthokeratology for myopia control treatment.
No interventions assigned to this group
(3) low-dose atropine
Assess accommodative function of myopic children using low-dose atropine eye drops for myopia control treatment.
No interventions assigned to this group
(4) single vision spectacle correction (control)
Assess accommodative function of myopic children wearing single vision spectacle lenses.
No interventions assigned to this group
Interventions
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Auditory biofeedback traing
Subjects who wear MFCLs for myopia control will receive one episode of auditory biofeedback training, and their accommodative responses to various demands (0, 2.5, 3, and 4 D) before and after the training were measured using a power refractor.
Eligibility Criteria
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Inclusion Criteria
* Age 8 - 15 years
* Refractive error spherical equivalent between -0.75 D and -10 D
* Astigmatism ≤ 0.75 D
* Age-appropriate amplitude of accommodation
* No suspected or confirmed eye disease (anamnesis)
* No accommodative or binocular function abnormalities
* Agreement to participate in the study (informed consent of parents, assent of child)
* Children who are currently under myopia control treatment should already be so for ≥ 6 months
Exclusion Criteria
* Refractive error spherical equivalent \< -10 D and \> -0.75 D
* Astigmatism \> 0.75 D
* Abnormal binocular functions
* Medication affecting accommodative response or causing dry eye
8 Years
15 Years
ALL
Yes
Sponsors
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University Hospital Tuebingen
OTHER
State University of New York College of Optometry
OTHER
Responsible Party
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Xiaoying Zhu, OD, PhD, MD, MS, FAAO
Assistant Clinical Professor
Principal Investigators
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Stewart Bloomfield, PhD
Role: STUDY_DIRECTOR
State University of New York College of Optometry
Locations
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State University of New York, College of Optometry
Long Beach, New York, United States
Countries
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Other Identifiers
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IRBNET ID 1525840
Identifier Type: -
Identifier Source: org_study_id
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