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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807361
• Other study ID #: IRBNET ID 1525840
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 12, 2022

Study information

• Verified date: January 2023
• Source: State University of New York College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Accomodation
• Biofeedback Training
• Myopia

Intervention

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.

Locations

Country	Name	City	State
United States	State University of New York, College of Optometry	Long Beach	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York College of Optometry	University Hospital Tuebingen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodation	Subjects' accommodative response will be measured using a power refractor	Within 4 weeks