MyopiaNCT05174780
Myopia Control With a Innovative Spectacle Lens
A study testing Single vision spectacle lens in people with Myopia, run by Essilor International at 9 sites in United States.
Trial summary
The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Single vision spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 9 sitesUnited States
- Study dates
- 29 Dec 2021to 20 Oct 2025
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Equal to or greater than 6 years and not older than 12 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.50 D in each eye.
- Astigmatism, if present, of not more than 1.50 D.
- Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
- Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
- Agree to wear spectacles for ≥10 hours/day at least 6 days/week.
- Willingness and ability to participate in trial for 3 years and attend scheduled visits.
Who cannot join
- History of myopia control intervention (e.g., atropine, orthokeratology, multifocal contact lenses, etc.)
- Strabismus by cover test at near or distance wearing correction.
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- Current or anticipated use of growth hormones.
- Participation in any clinical study within 30 days of the Baseline visit.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New England College of Optometry
Boston, Massachusetts, 02115
Illinois College of Optometry
Chicago, Illinois, 60616
Mann Eye Institute
Houston, Texas, 77002
Sabal Eye Care
Longwood, Florida, 32779
SUNY College of Optometry
New York, New York, 10036
Kannarr Eye Care
Pittsburg, Kansas, 66762
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Scripps Poway Optometry
San Diego, California, 92131
Sacco Eye Group
Vestal, New York, 13850
About this study
Official title: Clinical Evaluation of A Innovative Spectacle Lens in Slowing Myopia Progression
The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.
- Conditions
- Myopia
- Being tested
- innovative myopia control spectacle lens, Single vision spectacle lens
- Keywords
- spectacle, myopia control, myopia, HAL, Stellest, Essilor
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
innovative myopia control spectacle lensDevice
using a innovative spectacle lens to control myopia progression
Single vision spectacle lensDevice
single vision spectacle lens for myopia and astigmatism correction
| Study group | Role | What they receive |
|---|---|---|
| Innovative myopia control spectacle lens | Experimental | Not described Receives: Device: innovative myopia control spectacle lens |
| Single vision spectacle lens | Placebo comparator | Not described Receives: Device: Single vision spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Change in axial length from baseline
Measured: 36 Months
Cycloplegic spherical equivalent refraction
Change in cycloplegic spherical equivalent refraction from baseline
Measured: 36 Months
Secondary outcomes (2)
Axial length
Change in axial length from baseline
Measured: 24 Months
Cycloplegic spherical equivalent refraction
Change in cycloplegic spherical equivalent refraction from baseline
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start29 Dec 2021
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174780
- Sponsor's protocol ID
- WS10246
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Shen J, Hunt C, Young G, Drobe B. Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2026 Aug 20:e263288. doi: 10.1001/jamaophthalmol.2026.3288. Online ahead of print.
PubMed 42623028
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of A Innovative Spectacle Lens in Slowing Myopia Progression
- ClinicalTrials.gov ID
- NCT05174780
- Acronym / sponsor ID
- WS10246
- Conditions
- Myopia
- Keywords
- spectacle, myopia control, myopia, HAL, Stellest, Essilor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 3 Jan 2022 (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 demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innovative myopia control spectacle lens | Experimental | Device: innovative myopia control spectacle lens |
| Single vision spectacle lens | Placebo comparator | Device: Single vision spectacle lens |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Equal to or greater than 6 years and not older than 12 years at time of informed consent and assent.
- Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.50 D in each eye.
- Astigmatism, if present, of not more than 1.50 D.
- Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
- Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
Key exclusion criteria (7 listed)
- History of myopia control intervention (e.g., atropine, orthokeratology, multifocal contact lenses, etc.)
- Strabismus by cover test at near or distance wearing correction.
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
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 |
|---|---|---|
| innovative myopia control spectacle lensusing a innovative spectacle lens to control myopia progression | Device | Innovative myopia control spectacle lens |
| Single vision spectacle lenssingle vision spectacle lens for myopia and astigmatism correction | Device | Single vision spectacle lens |
Primary outcome
Axial length
Time frame: 36 Months
Change in axial length from baseline
Cycloplegic spherical equivalent refraction
Time frame: 36 Months
Change in cycloplegic spherical equivalent refraction from baseline
2 secondary outcomes
Axial length
Time frame: 24 Months
Cycloplegic spherical equivalent refraction
Time frame: 24 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 22 Dec 2025.
- Derived from this study: PubMed 42623028Shen J, Hunt C, Young G, Drobe B. Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2026 Aug 20:e263288. doi: 10.1001/jamaophthalmol.2026.3288. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single vision spectacle lens in people with Myopia, run by Essilor International at 9 sites 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 7 inclusion and 7 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. 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: 36 Months). 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?
On the ClinicalTrials.gov record for NCT05174780, which also lists 1 linked publication.
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 22 Dec 2025.