MedTrace Logo

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

NCT04807361 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2023-01-04

No results posted yet for this 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.

Conditions

  • Accomodation
  • Biofeedback Training
  • Myopia

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • State University of New York College of Optometry

    lead OTHER

Principal Investigators

  • Stewart Bloomfield, PhD · State University of New York College of Optometry

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-12
Completion
2022-12-12

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807361 on ClinicalTrials.gov