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

Completed

• Conditions: Myopia; Accomodation; Biofeedback Training
• Interventions: Behavioral: Auditory biofeedback traing

• Registration Number: NCT04807361
• Lead Sponsor: State University of New York College of Optometry

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-01
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
(1) Multifocal soft contact lenses (MFCLs)	Auditory biofeedback traing	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.

Primary Outcome Measures

Name	Time	Method
Accommodation	Within 4 weeks	Subjects' accommodative response will be measured using a power refractor

Trial Locations

Locations (1)

State University of New York, College of Optometry; 🇺🇸 Long Beach, New York, United States