NCT05684250

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 1, 2023

Last Update Submit

January 11, 2023

Conditions

Accomodation

Outcome Measures

Primary Outcomes (1)

  • Accommodation

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

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

Study Arms (3)

The time course group

EXPERIMENTAL

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.

Behavioral: Auditory biofeedback training

The repetition group

EXPERIMENTAL

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.

Behavioral: Auditory biofeedback training

The longer duration group

EXPERIMENTAL

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.

Behavioral: Auditory biofeedback training

Interventions

Auditory biofeedback trainingBEHAVIORAL

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.

The longer duration groupThe repetition groupThe time course group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York, College of Optometry

New York, New York, 10036, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 13, 2023

Study Start

July 19, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

US(1)