MyopiaNCT04763694

Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control

A study testing Multifocal soft contact lenses in people with Myopia and Accommodation, run by State University of New York College of Optometry at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations. The study objectives are to: 1. Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period. 2. Read more about this study

Who is it for?: Ages 8 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Myopia, Accommodation
What is being tested?: Multifocal soft contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2018to 5 Dec 2020
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 8 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age: 8-17 years
Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D
Monocular BCVA 20/25 or better
No previous CL experience required

Who cannot join

History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.

Trial locations and contacts

1 site in 1 country.

United States1 site

State University of New York
New York, New York, 10036

Other trials in United States

About this study

The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations.

The study objectives are to:

Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.
Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.

Conditions: Myopia, Accommodation
Being tested: Multifocal soft contact lenses
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multifocal soft contact lensesDevice
Myopic subjects wore multifocal soft contact lenses for 12 months

Study groups in NCT04763694
Study group	Role	What they receive
Treatment arm	Experimental	Subjects wore multifocal soft contact lenses for 12 months. Receives: Device: Multifocal soft contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Axial length
Change in axial length over the duration of the study
Measured: 12 months
Refractive error
Change in refractive error over the duration of the study
Measured: 12 months
Accommodation
Accommodation at various distances during the study
Measured: 12 months

Secondary outcomes (1)

Phoria
The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20185 Dec 2020

First posted21 Feb 2021
Study start1 Oct 2018
Primary completion5 Dec 2020
Study completion5 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyopiaStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04763694
Sponsor's protocol ID: IRBNET ID 1325316
Status last verified: Feb 2021
First submitted: 11 Feb 2021
Last updated: 21 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
ClinicalTrials.gov ID: NCT04763694
Acronym / sponsor ID: IRBNET ID 1325316
Conditions: Myopia, Accommodation
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: State University of New York College of OptometryUniversity, hospital or other
Study start: 1 Oct 2018 (actual)
Primary completion: 5 Dec 2020 (actual)
Study completion: 5 Dec 2020 (actual)
First posted: 21 Feb 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.

The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations.

The study objectives are to:

Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.
Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment arm	Experimental	Device: Multifocal soft contact lensesSubjects wore multifocal soft contact lenses for 12 months.

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Age: 8-17 years
Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D
Monocular BCVA 20/25 or better
No previous CL experience required

Key exclusion criteria (1 listed)

History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.

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
Multifocal soft contact lensesMyopic subjects wore multifocal soft contact lenses for 12 months	Device	Treatment arm

Primary outcome

Axial length
Time frame: 12 months
Change in axial length over the duration of the study
Refractive error
Time frame: 12 months
Change in refractive error over the duration of the study
Accommodation
Time frame: 12 months
Accommodation at various distances during the study

1 secondary outcome

Phoria
Time frame: 12 months

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 21 Feb 2021.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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?

A study testing Multifocal soft contact lenses in people with Myopia and Accommodation, 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 4 inclusion and 1 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 21 Feb 2021. 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?

Axial length (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04763694.

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 21 Feb 2021.