MyopiaPhase 2NCT05815784
Myopia Control: a Comparison Study Between Atropine and MiSight
A Phase 2 study testing Atropine and MiSight contact lenses in people with Myopia, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine and MiSight contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 1 Jan 2028
- Phase
- Phase 2
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age of 5-12 years old at their baseline exam
- Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
- Gestational age ≥ 32 weeks.
- Birth weight >1500g.
Who cannot join
- Current or previous form of myopia control
- Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
- Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
- Abnormality of cornea, lens, central retina, iris, or ciliary body
- Current or prior history of manifest strabismus, amblyopia, or nystagmus
- Current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent.
Show all 16Show fewer
- Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
- Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
- Abnormality of the cornea, lens, central retina, iris, or ciliary body.
- Prior eyelid, strabismus, intraocular, or refractive surgery.
- Down syndrome or cerebral palsy.
- Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
- Existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., Down syndrome) which may influence refractive development
- Any condition that in the judgement of the investigator could potentially influence refractive development.
- Existing conditions 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, diabetes mellitus, pre-diabetes)
- Inability to comprehend and/or perform any study-related clinical tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
This research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. As a result, this study will improving our best practices for myopia control in pediatric patients.
- Conditions
- Myopia
- Being tested
- Atropine, MiSight 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.
AtropineDrug
0.05% atropine. One drop per eye per day for 2 years.
MiSight contact lensesDevice
Daily wear for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | No treatment. |
| Atropine | Other | 0.05% atropine. One drop per eye per day for 2 years. Receives: Drug: Atropine |
| MiSight contact lenses | Other | MiSight contact lenses. Daily wear for 2 years. Receives: Device: MiSight 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 (as measured by biometry) over a 2-year time period
Measured: 2 years
Refractive error
change in refractive error over a 2-year time period
Measured: 2 years
Secondary outcomes (4)
compliance with treatment
Measured: 2 years
reported side effects
Measured: 2 years
success rate of contact lens fitting in the younger children
Measured: 2 years
contact lens tolerance in the younger children
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start2 May 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Stec, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Magdalena Stec, OD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815784
- Sponsor's protocol ID
- 2022-5570
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
- ClinicalTrials.gov ID
- NCT05815784
- Acronym / sponsor ID
- 2022-5570
- Conditions
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Apr 2023 (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 research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. As a result, this study will improving our best practices for myopia control in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –No treatment. |
| Atropine | Other | Drug: Atropine0.05% atropine. One drop per eye per day for 2 years. |
| MiSight contact lenses | Other | Device: MiSight contact lensesMiSight contact lenses. Daily wear for 2 years. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children age of 5-12 years old at their baseline exam
- Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
- Gestational age ≥ 32 weeks.
- Birth weight >1500g.
Key exclusion criteria (16 listed)
- Current or previous form of myopia control
- Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
- Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
- Abnormality of cornea, lens, central retina, iris, or ciliary body
- Current or prior history of manifest strabismus, amblyopia, or nystagmus
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 |
|---|---|---|
| Atropine0.05% atropine. One drop per eye per day for 2 years. | Drug | Atropine |
| MiSight contact lensesDaily wear for 2 years. | Device | MiSight contact lenses |
Primary outcome
axial length
Time frame: 2 years
change in axial length (as measured by biometry) over a 2-year time period
Refractive error
Time frame: 2 years
change in refractive error over a 2-year time period
4 secondary outcomes
compliance with treatment
Time frame: 2 years
reported side effects
Time frame: 2 years
success rate of contact lens fitting in the younger children
Time frame: 2 years
contact lens tolerance in the younger children
Time frame: 2 years
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 22 Jul 2026.
Related trials for Myopia
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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.
Magdalena Stec, OD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atropine and MiSight contact lenses in people with Myopia, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 16 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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: 2 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 22 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.