CompletedNot Applicable

Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)

United States44 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range

8 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Best corrected monocular Snellen visual acuity (VA) ≧ 20/25 * 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: * Persons who are incapable of giving consent * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accommodation

Timeframe: Within 4 weeks

Trial details

NCT IDNCT04807361

SponsorState University of New York College of Optometry

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-12

View on ClinicalTrials.gov More Accomodation trials