Recruiting

Biofeedback TrainingEffect of Biofeedback Training on Accommodation During Multifocal Lens Wear in Young Adults

Sponsor:

State University of New York College of Optometry

Code:

NCT05684250

Conditions

Accomodation

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Auditory biofeedback training

Study Details

Brief summary:

This study will examine the accommodative behavior in young adults wearing multifocal soft contact lenses. undergoing myopia control treatments. Subjects will undergo auditory biofeedback training while wearing the multifocal contact lenses to improve the accommodative. This pilot study is divided into three separate experiments and aims to assess:

1. the time course of the effect of biofeedback training in young adults wearing MFCLs -- the time course group
2. whether repeated biofeedback training increases the efficacy in young adults wearing MFCLs -- the repetition group
3. whether a longer training duration, given repeatedly, increases the efficacy in young adults wearing MFCLs -- the longer duration group

The results of this study will be used to design a larger clinical trial to investigate whether increasing accommodative responses through the multifocal contact lenses increases multifocal lenses' treatment effect on myopia management in children.

Conditions

Accomodation

Study ID

NCT05684250

Start date

Jul 19, 2022

Status verified date

Jan, 2023

Completion date

May 31, 2024

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Inclusion Criteria:

Best corrected monocular Snellen visual acuity (VA) ≧ 20/25
Age 18 to 30 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 subjects)

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The time course group

The time course of the effect of biofeedback training in young adults wearing MFCLs. Subjects will receive one episode of auditory biofeedback training and accommodation will be measured before the training and after the training on a weekly basis for 3 weeks.

experimental: The repetition group

Subjects will receive one episode of auditory biofeedback training every week for 3 weeks and accommodation will be measured before the training and after the training on a weekly basis.

experimental: The longer duration group

Subjects will receive one episode of auditory biofeedback training for twice as long every week for 3 weeks and accommodation will be measured before the training and after the training on a weekly basis.

Interventions

Auditory biofeedback training

For the auditory biofeedback training, subjects are provided with two tones while fixating a target, one tone related to their accommodative response and the second to the target distance. Their task is to match these tones.

Primary outcome measure

Accommodation [ Time Frame: Immediately before and after one episode of auditory biofeedback training. Change in accommodation from the baseline will be assessed weekly for 3 weeks. ]

Central Contacts and Locations

Locations

State University of New York, College of Optometry

Recruiting

New York, New York, United States, 10036

Contacts

Xiaoying Zhu, OD, PhD, MD, MS, FAAO

2129385541 xzhu@sunyopt.edu

Robert McPeek, PhD

212-938-5762 rmcpeek@sunyopt.edu

More Information

Sponsor

State University of New York College of Optometry

Last update posted

Jan 13, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York College of Optometry on 2023-01-13.