MyopiaPhase 3NCT07095894
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
A Phase 3 study testing Atropine and Spectacles with HAL in people with Myopia, run by Jaeb Center for Health Research at 18 sites in United States.
Trial summary
To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine and Spectacles with HAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 18 sitesUnited States
- Study dates
- 1 Jul 2026to 1 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5 years to <12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.
- Refractive error meeting the following by cycloplegic autorefraction:
- Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye
- Astigmatism <2.50D both eyes
- Anisometropia <1.50D SER
- Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method:
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- VA is age normal in both eyes1,2
- 5-6 years: approximately 20/32 or better, ≤ 0.24 logMAR, ≥ 73 letters
- 7-12 years: approximately 20/25 or better, ≤ 0.14 logMAR, ≥ 78 letters
- Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters
- Wearing spectacles by parent report ≥90% of waking hours ≥30 days duration before enrollment. For children who meet all other inclusion criteria but whose single-vision spectacles are broken or lost within the last 90 days, enrollment can proceed as long as the child was wearing their single-vision spectacles ≥90% of waking hours ≥30 days before the spectacles were broken or lost.
- Gestational age ≥ 32 weeks.
- Birth weight >1500 g.
- Parent(s) and assenting child understand the study procedures and are willing to accept randomization to atropine 0.05%, HAL lenses, atropine combined with HAL lenses, or placebo (i.e., neither active treatment).
- Parent is willing to participate in a 2- to 4-week run-in phase using nightly artificial tear eyedrops in both eyes.
- Family can return in 2 to 4 weeks for possible randomization.
- Child is willing to refrain from contact lenses for the duration of the study.
- Parent has a phone (or access to a phone) and is willing to be contacted by the clinical site staff.
- Relocation outside of the area of an active PEDIG site within the next 32 months is not anticipated.
Who cannot join
- Current or previous pharmacologic or light therapy used for myopia treatment.
- Current or prior contact lens wear more than 7 days in the past 12 months
- Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses.
- Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression.
- Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents.
- Known atropine allergy
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- Known allergy to shellfish
- Abnormality of the cornea, lens, central retina, iris, or ciliary body
- Current constant or intermittent strabismus (phorias are acceptable)
- Verified history of amblyopia or nystagmus.
- Prior strabismus, intraocular, or refractive surgery
- Down syndrome or cerebral palsy
- Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Graves' disease, myasthenia gravis, diabetes mellitus)
- Any condition that, in the judgment of the investigator, could influence refractive error development.
- Existing conditions in the opinion of the investigator that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, pre-diabetes).
- Inability to comprehend and/or perform any study-related procedures.
- Individuals who are pregnant, lactating, or intending to become pregnant within the next 30 months.
- A negative urine pregnancy test at randomization and the 6-, 12-, 18-, and 24-month follow-up visits will be required for individuals who have experienced menarche (at least one menstrual cycle).
- Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is investigative site personnel directly affiliated with this study or who is an employee of the Jaeb Center for Health Research.
- Sibling of, or living in the same household as, another child who is concurrently enrolled in the study.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294
Katherine K Weise, (205) 996-0203, kweise@uab.edu
- Recruiting
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453
Aparna Raghuram, O.D., Ph.D., 617-355-6401, aparna.raghuram@childrens.harvard.edu
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Noreen Shaikh, OD, 312-227-6719, noshaikh@luriechildrens.org
- Recruiting
Illinois College of Optometry
Chicago, Illinois, 60616
Yi Pang, OD, PhD, 312-949-7287, ypang@ico.edu
- Recruiting
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205
Catherine O Jordan, MD, (614) 224-6222, cateolsonjordan@gmail.com
- Recruiting
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Ann M Morrison, O.D., (614) 688-3336, morrison.421@osu.edu
- Recruiting
Duke University Eye Center
Durham, North Carolina, 27710
Nathan L Cheung, OD, nathan.cheung@duke.edu
- Recruiting
Marshall B. Ketchum University
Fullerton, California, 92831
Angela Chen, O.D., M.S., 714-449-7432, angelachen@ketchum.edu
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Allegra P Burgher, OD, 616-267-2605, allegra.burgher@helendevoschildrens.org
- Recruiting
University of Houston - College of Optometry
Houston, Texas, 77204
Maureen Plaumann, 713-743-2005, mdplaumann@uh.edu
- Recruiting
Conestoga Eye
Lancaster, Pennsylvania, 17601
Hayley L Woodall, OD, 717-541-9700, hayleywoodall@me.com
- Recruiting
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Lori Ann Kehler, OD, 615-936-2020, lori.kehler@vanderbilt.edu
- Recruiting
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
Eric Crouch, MD, 757-461-0050, ercrouch@gmail.com
- Recruiting
Stanford University
Palo Alto, California, 94303
Tawna L Roberts, OD, 650-724-7115, tawnar@stanford.edu
- Recruiting
Pennsylvania College of Optometry, Salus at Drexel University
Philadelphia, Pennsylvania, 19141
Erin Jenewein, OD, (215) 276-6034, ej468@drexel.edu
- Recruiting
Casey Eye Institute
Portland, Oregon, 97239
Allison Summers, OD, 503-494-7830, summersa@ohsu.edu
- Recruiting
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, 84107
David Petersen, MD, 801-264-4450, DPetersen@RMEyecare.com
- Recruiting
University of Arizona
Tucson, Arizona, 85711
Jonathan M Holmes, MD, (520) 321-3677, jmholmes@arizona.edu
About this study
Official title: A Randomized Placebo-controlled Trial of Spectacles With Highly Aspherical Lenslet Target (H.A.L.T.) MAX Technology or 0.05% Atropine to Slow Progression of Myopia in Children
To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children.
Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth.
Read more
After a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to <12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively.
All children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months).
The study is funded by the National Eye Institute, part of the NIH, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of Spectacle lenses with H.A.L.T.* MAX technology, is providing the eyeglasses and financial support for the study. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.
- Conditions
- Myopia
- Being tested
- Atropine, Spectacles with HAL, Placebo Eyedrops
- Keywords
- myopia, spectacles, atropine, pediatric
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Daily 0.05% atropine eyedrops
Spectacles with HALDevice
Spectacle lenses with highly aspherical lenslets (HAL)
Placebo EyedropsDrug
Daily placebo eyedrops
| Study group | Role | What they receive |
|---|---|---|
| Atropine Group | Experimental | Daily low-concentration atropine (0.05%) eyedrops plus spectacles with single vision lenses (SVL) Receives: Drug: Atropine |
| Placebo Group | Placebo comparator | Daily placebo eyedrops plus spectacles with single-vision lenses (SVL) Receives: Drug: Placebo Eyedrops |
| HAL Group | Experimental | Daily placebo eyedrops plus spectacles with highly aspherical lenslets Receives: Device: Spectacles with HAL; Drug: Placebo Eyedrops |
| Combined Group | Experimental | Daily low-concentration atropine (0.05%) eyedrops plus spectacles with highly aspherical lenslets Receives: Drug: Atropine; Device: Spectacles with HAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy outcome - change in axial length
Change in axial length from baseline to 24 months (on-treatment) as measured by a masked examiner using cycloplegic biometry.
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 posted31 Jul 2025
- Study start1 Jul 2026
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Ann F Kehler, OD, Study chair, Vanderbilt University Medical CenterKatherine A Lee, MD, PhD, Study chair, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095894
- Sponsor's protocol ID
- MTS2
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Trial of Spectacles With Highly Aspherical Lenslet Target (H.A.L.T.) MAX Technology or 0.05% Atropine to Slow Progression of Myopia in Children
- ClinicalTrials.gov ID
- NCT07095894
- Acronym / sponsor ID
- MTS2
- Conditions
- Myopia
- Keywords
- myopia, spectacles, atropine, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 31 Jul 2025 (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.
To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children.
Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth.
After a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to <12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively.
All children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months).
The study is funded by the National Eye Institute, part of the NIH, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of Spectacle lenses with H.A.L.T.* MAX technology, is providing the eyeglasses and financial support for the study. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Atropine Group | Experimental | Drug: AtropineDaily low-concentration atropine (0.05%) eyedrops plus spectacles with single vision lenses (SVL) |
| Placebo Group | Placebo comparator | Drug: Placebo EyedropsDaily placebo eyedrops plus spectacles with single-vision lenses (SVL) |
| HAL Group | Experimental | Device: Spectacles with HAL, Drug: Placebo EyedropsDaily placebo eyedrops plus spectacles with highly aspherical lenslets |
| Combined Group | Experimental | Drug: Atropine, Device: Spectacles with HALDaily low-concentration atropine (0.05%) eyedrops plus spectacles with highly aspherical lenslets |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Age 5 years to <12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.
- Refractive error meeting the following by cycloplegic autorefraction:
- Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method:
- Wearing spectacles by parent report ≥90% of waking hours ≥30 days duration before enrollment. For children who meet all other inclusion criteria but whose single-vision spectacles are broken or lost within the last 90 days, enrollment can proceed as long as the child was wearing their single-vision spectacles ≥90% of waking hours ≥30 days before the spectacles were broken or lost.
- Gestational age ≥ 32 weeks.
Key exclusion criteria (20 listed)
- Current or previous pharmacologic or light therapy used for myopia treatment.
- Current or prior contact lens wear more than 7 days in the past 12 months
- Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses.
- Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression.
- Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents.
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 |
|---|---|---|
| AtropineDaily 0.05% atropine eyedrops | Drug | Atropine Group, Combined Group |
| Spectacles with HALSpectacle lenses with highly aspherical lenslets (HAL) | Device | Combined Group, HAL Group |
| Placebo EyedropsDaily placebo eyedrops | Drug | HAL Group, Placebo Group |
Primary outcome
Primary efficacy outcome - change in axial length
Time frame: 24 months.
Change in axial length from baseline to 24 months (on-treatment) as measured by a masked examiner using cycloplegic biometry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
Lori Ann F Kehler, OD study chair
Vanderbilt University Medical Center
Katherine A Lee, MD, PhD study chair
Jaeb Center for Health Research
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine and Spectacles with HAL in people with Myopia, run by Jaeb Center for Health Research at 18 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 19 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond T Kraker, MSPH (813-975-8690, rkraker@jaeb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy outcome - change in axial length (time frame: 24 months.). 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 2 Nov 2026.