AccomodationNCT05684250
Effect of Biofeedback Training on Accommodation During Multifocal Lens Wear in Young Adults
A study testing Auditory biofeedback training in people with Accomodation, run by State University of New York College of Optometry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Accomodation
- What is being tested?
- Auditory biofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
State University of New York, College of Optometry
New York, New York, 10036
Xiaoying Zhu, OD, PhD, MD, MS, FAAO, 2129385541, xzhu@sunyopt.edu
Robert McPeek, PhD, 212-938-5762, rmcpeek@sunyopt.edu
About this study
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.
Read the 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
- Conditions
- Accomodation
- Being tested
- Auditory biofeedback training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory biofeedback trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Auditory biofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodation
Accommodative response to 0, 2.5, 3, and 4 D while subjects wear multifocal contact lenses are measured using an infrared powerrefractor.
Measured: Immediately before and after one episode of auditory biofeedback training. Change in accommodation from the baseline will be assessed weekly for 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start19 Jul 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccomodationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- William G. & Helen C. Hoffman Foundation
- Responsible party
- Principal investigator, Xiaoying Zhu, OD, PhD, MD, MS, FAAO, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684250
- Sponsor's protocol ID
- IRBNET.ORG 1933308
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofeedback Training on Accommodation During Multifocal Lens Wear in Young Adults
- ClinicalTrials.gov ID
- NCT05684250
- Acronym / sponsor ID
- IRBNET.ORG 1933308
- Conditions
- Accomodation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Collaborators
- William G. & Helen C. Hoffman Foundation
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The time course group | Experimental | Behavioral: Auditory biofeedback trainingThe 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. |
| The repetition group | Experimental | Behavioral: Auditory biofeedback trainingSubjects 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. |
| The longer duration group | Experimental | Behavioral: Auditory biofeedback trainingSubjects 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory biofeedback trainingFor 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. | Behavioural | The longer duration group, The repetition group, The time course group |
Primary outcome
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.
Accommodative response to 0, 2.5, 3, and 4 D while subjects wear multifocal contact lenses are measured using an infrared powerrefractor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory biofeedback training in people with Accomodation, run by State University of New York College of Optometry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.