Refractive ErrorsNCT04352868
Customizing Myopia Control With Multifocal Toric Contact Lens
A study testing Intelliwave multifocal, toric, soft contact lens and Intelliwave toric, soft contact lens in people with Refractive Errors and Myopia, run by University of Alabama at Birmingham.
Trial summary
This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Refractive Errors, Myopia
- What is being tested?
- Intelliwave multifocal, toric, soft contact lens and Intelliwave toric, soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2022
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 12 years, inclusive, at baseline examination
- -0.50 to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
- ≥0.75 DC, cycloplegic autorefraction
- 0.1 logMAR or better best-corrected visual acuity in each eye
Who cannot join
- Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
- Ocular surgery, severe ocular trauma, active ocular infection or inflammation
- Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
About this study
This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.
Read the detailed description
The purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. Multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. This outcome is yet to be evaluated in children with myopia plus astigmatism.The secondary outcome is to measure the change in peripheral optics caused by the contact lens. This information is key to understanding the mechanism of multifocal contact lens optics on the eye. Ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. This software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.
- Conditions
- Refractive Errors, Myopia
- Being tested
- Intelliwave multifocal, toric, soft contact lens, Intelliwave toric, soft contact lens
- Keywords
- Myopia, Multifocal contact lens, Refractive error, Myopia treatment, Myopia control, Myopia management
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelliwave multifocal, toric, soft contact lensDevice
This is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc.
Intelliwave toric, soft contact lensDevice
This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Toric soft contact lens | Active comparator | Toric soft contact lens Receives: Device: Intelliwave toric, soft contact lens |
| Multifocal toric soft contact lens | Experimental | A multifocal toric soft contact lens with a +2.00 D add. Receives: Device: Intelliwave multifocal, toric, soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive error progression
Refractive error measured by cycloplegic autorefraction in both eyes, will be measured at baseline and at one year to assess the difference in spherical component of the refractive error between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)
Measured: 1 years
Axial length
Change in axial length as measured by non-contact axial length both eyes, will be measured at baseline and at one year to assess the difference in change in axial length between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Pucker, University of Alabama at Birmingham
- Investigators
- Andrew D Pucker, OD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352868
- Sponsor's protocol ID
- IRB-300004596
- Status last verified
- Nov 2020
- First submitted
- 15 Apr 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual subject data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customizing Myopia Control With Multifocal Toric Contact Lens
- ClinicalTrials.gov ID
- NCT04352868
- Acronym / sponsor ID
- IRB-300004596
- Conditions
- Refractive Errors, Myopia
- Keywords
- Myopia, Multifocal contact lens, Refractive error, Myopia treatment, Myopia control, Myopia management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 20 Apr 2020 (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 evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.
Detailed description
The purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. Multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. This outcome is yet to be evaluated in children with myopia plus astigmatism.The secondary outcome is to measure the change in peripheral optics caused by the contact lens. This information is key to understanding the mechanism of multifocal contact lens optics on the eye. Ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. This software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric soft contact lens | Active comparator | Device: Intelliwave toric, soft contact lensToric soft contact lens |
| Multifocal toric soft contact lens | Experimental | Device: Intelliwave multifocal, toric, soft contact lensA multifocal toric soft contact lens with a +2.00 D add. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8 to 12 years, inclusive, at baseline examination
- -0.50 to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
- ≥0.75 DC, cycloplegic autorefraction
- 0.1 logMAR or better best-corrected visual acuity in each eye
Key exclusion criteria (3 listed)
- Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
- Ocular surgery, severe ocular trauma, active ocular infection or inflammation
- Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
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 |
|---|---|---|
| Intelliwave multifocal, toric, soft contact lensThis is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc. | Device | Multifocal toric soft contact lens |
| Intelliwave toric, soft contact lensThis is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc. | Device | Toric soft contact lens |
Primary outcome
Refractive error progression
Time frame: 1 years
Refractive error measured by cycloplegic autorefraction in both eyes, will be measured at baseline and at one year to assess the difference in spherical component of the refractive error between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)
Axial length
Time frame: 1 years
Change in axial length as measured by non-contact axial length both eyes, will be measured at baseline and at one year to assess the difference in change in axial length between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No. There is no plan to share individual subject data.
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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.
Andrew D Pucker, OD, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Intelliwave multifocal, toric, soft contact lens and Intelliwave toric, soft contact lens in people with Refractive Errors and Myopia, run by University of Alabama at Birmingham.
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 3 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: withdrawn, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Refractive error progression (time frame: 1 years). The study lists 2 primary outcomes in all. 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 9 Nov 2020.