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OpenTrials
Completed

NCT Number: NCT04807361

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 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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

State University of New York, College of Optometry

Long Beach, New York, 11561, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory biofeedback traing

Behavioral

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.

Primary outcomes

  1. Accommodation

    Time frame: Within 4 weeks

    Subjects' accommodative response will be measured using a power refractor

Sponsors and collaborators

Lead sponsor

State University of New York College of Optometry

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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