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

Primary Purpose

Accomodation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory biofeedback training
Sponsored by
State University of New York College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accomodation

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • State University of New York, College of OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

The time course group

The repetition group

The longer duration group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Accommodation
Accommodative response to 0, 2.5, 3, and 4 D while subjects wear multifocal contact lenses are measured using an infrared powerrefractor.

Secondary Outcome Measures

Full Information

First Posted
January 1, 2023
Last Updated
January 11, 2023
Sponsor
State University of New York College of Optometry
Collaborators
William G. & Helen C. Hoffman Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05684250
Brief Title
Effect of Biofeedback Training on Accommodation During Multifocal Lens Wear in Young Adults
Official Title
Effect of Biofeedback Training on Accommodation During Multifocal Lens Wear in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York College of Optometry
Collaborators
William G. & Helen C. Hoffman Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: the time course of the effect of biofeedback training in young adults wearing MFCLs -- the time course group whether repeated biofeedback training increases the efficacy in young adults wearing MFCLs -- the repetition group 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.
Detailed Description
The public health systems worldwide might soon face an increase in highly myopic patients and with this a rising number of cases with severe eye diseases. By 2050, about five billion people are expected to be myopic and one billion might suffer from a myopia of more than -5 D. According to the World Health Organization, myopia is one of the top factors leading to avoidable blindness. For decades, researchers have been investigating the etiology of this refractive error as well as methods to prevent its progression in children myopic. Among the currently available treatments to slow myopia progression, optical interventions were shown to be a promising and feasible non-invasive approach. Hyperopic retinal defocus is known to induce ocular axial elongation and may be a factor in the progression of myopia. Positive defocus has been shown to reduce axial elongation and contact lenses with bi- or multifocal power profiles that add positive power to the central distance have been used to reduce myopia progression in children. Clinical trial outcomes show progression to be reduced, on average, by 38% on average, but with variable results. This variability may be related to the ways patients accommodate through the lenses. An earlier study found that children wearing multifocal lenses may under-accommodate at near, which could reduce the efficacy of the lenses. Biofeedback training has been used to change accommodation. Earlier studies attempted to reduce accommodation based on the hypothesis that functional myopia results from a spasm of the ciliary muscle. In contrast, a recent study with young adult myopes successfully applied auditory biofeedback training to *increase* accommodation accuracy and reduce the accommodative lag in individuals by 0.3 D or more at different dioptric distances and while myopic subjects wore multifocal contact lenses. If accommodation was increased by means of auditory biofeedback training in myopic children wearing multifocal soft contact lenses, the treatment efficacy of the lenses might be improved. The purpose of this pilot study is to investigate whether the frequency and duration of auditory biofeedback training affect their efficacy in increasing accommodative responses through the multifocal lenses. • STUDY POPULATION Thirty subjects will be randomized to one of the three study groups: The time course group: The time course of the effect of biofeedback training (one episode) on accommodation in young adults wearing MFCLs will be measured weekly The repetition group: The effect of repeated biofeedback training (one episode per week for 3 weeks) on accommodation through the MFCLs will be measured weekly The longer duration group: The effect of repeated biofeedback training with longer duration (one episode per week for 3 weeks) on accommodation through the MFCLs will be measured weekly 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accomodation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The time course group
Arm Type
Experimental
Arm Description
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.
Arm Title
The repetition group
Arm Type
Experimental
Arm Description
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.
Arm Title
The longer duration group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Auditory biofeedback training
Intervention Description
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 Information:
Title
Accommodation
Description
Accommodative response to 0, 2.5, 3, and 4 D while subjects wear multifocal contact lenses are measured using an infrared powerrefractor.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
State University of New York, College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoying Zhu, OD, PhD, MD, MS, FAAO
Phone
2129385541
Email
xzhu@sunyopt.edu
First Name & Middle Initial & Last Name & Degree
Robert McPeek, PhD
Phone
212-938-5762
Email
rmcpeek@sunyopt.edu

12. IPD Sharing Statement

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

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