AccomodationNCT04807361
Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
An observational study of Accomodation and Biofeedback Training, 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 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… Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Accomodation, Biofeedback Training, Myopia
- What is being tested?
- Auditory biofeedback traing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 12 Dec 2022
- Phase
- Observational
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric population
Who may be able to join
- 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)
Show all 9Show fewer
- 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
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
State University of New York, College of Optometry
Long Beach, New York, 11561
About this study
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.
- Conditions
- Accomodation, Biofeedback Training, Myopia
- Being tested
- Auditory biofeedback traing
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory biofeedback traingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| (1) Multifocal soft contact lenses (MFCLs) | Assess accommodative function of myopic children wearing MFCLs for myopia control treatment. Accommodative stimulus-response functions and accommodative lags will be determined during one, one hour measurement session for four stimulus distances using an IR video refractometer (PowerRefractor). MFCL subjects will also be tested while wearing SVCL distance corrections for comparison. Receives: Behavioral: Auditory biofeedback traing | |
| (2) orthokeratology | Assess accommodative function of myopic children wearing Orthokeratology for myopia control treatment. | |
| (3) low-dose atropine | Assess accommodative function of myopic children using low-dose atropine eye drops for myopia control treatment. | |
| (4) single vision spectacle correction (control) | Assess accommodative function of myopic children wearing single vision spectacle lenses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodation
Subjects' accommodative response will be measured using a power refractor
Measured: Within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Dec 2020
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Principal investigator, Xiaoying Zhu, OD, PhD, MD, MS, FAAO, State University of New York College of Optometry
- Investigators
- Stewart Bloomfield, PhD, Study director, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807361
- Sponsor's protocol ID
- IRBNET ID 1525840
- Status last verified
- Jan 2023
- First submitted
- 17 Mar 2021
- Last updated
- 4 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
- ClinicalTrials.gov ID
- NCT04807361
- Acronym / sponsor ID
- IRBNET ID 1525840
- Conditions
- Accomodation, Biofeedback Training, Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 19 Mar 2021 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (1) Multifocal soft contact lenses (MFCLs) | – | Behavioral: Auditory biofeedback traingAssess accommodative function of myopic children wearing MFCLs for myopia control treatment. Accommodative stimulus-response functions and accommodative lags will be determined during one, one hour measurement session for four stimulus distances using an IR video refractometer (PowerRefractor). MFCL subjects will also be tested while wearing SVCL distance corrections for comparison. |
| (2) orthokeratology | – | –Assess accommodative function of myopic children wearing Orthokeratology for myopia control treatment. |
| (3) low-dose atropine | – | –Assess accommodative function of myopic children using low-dose atropine eye drops for myopia control treatment. |
| (4) single vision spectacle correction (control) | – | –Assess accommodative function of myopic children wearing single vision spectacle lenses. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric population
Key inclusion criteria (9 listed)
- 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
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 traingSubjects 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. | Behavioural | (1) Multifocal soft contact lenses (MFCLs) |
Primary outcome
Accommodation
Time frame: Within 4 weeks
Subjects' accommodative response will be measured using a power refractor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Stewart Bloomfield, PhD study director
State University of New York College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accomodation and Biofeedback Training, 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 9 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: finished, as of the sponsor's last update on 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accommodation (time frame: Within 4 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 4 Jan 2023.