MyopiaPhase 3MTS1NCT03334253

Low-Dose Atropine for Treatment of Myopia

A Phase 3 study testing Atropine in people with Myopia, run by Jaeb Center for Health Research at 13 sites 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

Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 13 sitesUnited States
Study dates: 1 Jun 2018to 12 Sep 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
Refractive error meeting the following by cycloplegic autorefraction:
Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
Astigmatism <=1.50D in both eyes
Anisometropia <1.00D SE
Gestational age ≥ 32 weeks.

Show all 12Show fewer

Birth weight >1500g.
Parent understands the protocol and is willing to accept randomization to atropine or placebo.
Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
Able to return in 2 to 4 weeks for possible randomization.
Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.

Who cannot join

Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
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.
Known atropine allergy.
Abnormality of the cornea, lens, central retina, iris or ciliary body.
Current or prior history of manifest strabismus, amblyopia, or nystagmus.

Show all 10Show fewer

Prior eyelid, strabismus, intraocular, or refractive surgery.
Down syndrome or cerebral palsy.
Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.
A negative urine pregnancy test will be required for all females who have experienced menarche.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

The Emory Eye Center Dept of Ophthalmology
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
St Luke's Hospital
Boise, Idaho, 83702
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453
Illinois College of Optometry
Chicago, Illinois, 60616
Ticho Eye Associates
Chicago Ridge, Illinois, 60415
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205
University of Houston College of Optometry
Houston, Texas, 77204
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, 73104
Eye Care Associates, Inc.
Poland, Ohio, 44514
Casey Eye Institute
Portland, Oregon, 97239
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Official title: Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)

Study Objectives

The objectives for this randomized trial are:

To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).
To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Read the detailed description

Study Objectives

The objectives for this randomized trial are:

To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).
To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Conditions: Myopia
Being tested: Atropine, Placebo Eyedrops
Keywords: Myopia, atropine
Medical subject headings: Myopia

What participants receive

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

AtropineDrug
Also called Low-Dose Atropine
Daily 0.01% atropine eyedrops
Placebo EyedropsOther
Daily placebo eyedrops

Study groups in NCT03334253
Study group	Role	What they receive
Atropine Group	Experimental	0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops Receives: Drug: Atropine
Placebo Group	Placebo comparator	Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops Receives: Other: Placebo Eyedrops

What is being measured

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

Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison).
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Measured: At 24 months
Primary Outcome Measure Stratified by Sex
NIH-required analysis. Primary outcome measure (stratified by sex):
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison).
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Measured: at 24 months
Primary Outcome Measure Stratified by Race
NIH-required analysis. Primary outcome measure (stratified by race):
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison).
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Measured: by 24 months
Primary Outcome Measure Stratified by Ethnicity
NIH-required analysis. Primary outcome measure (stratified by ethnicity):
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison).
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Measured: at 24 months
Primary Outcome: Mean Change in Spherical Equivalent Refractive Error at 24 Months
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.
Measured: 24 months

Secondary outcomes (1)

Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months.
Measured: At 30 months

Timeline

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

1 Jun 201812 Sep 2022

First posted7 Nov 2017
Study start1 Jun 2018
Primary completion15 Apr 2022
Study completion12 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03334253
Sponsor's protocol ID: MTS1
Other IDs: 2U10EY011751
Acronym: MTS1
Status last verified: Jun 2026
First submitted: 2 Nov 2017
Last updated: 31 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.

Publications

Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855.
PubMed 37440213
Weise KK, Repka MX, Zhu Y, Manny RE, Raghuram A, Chandler DL, Summers AI, Lee KA, Kehler LAF, Pang Y, Allen MS, Anderson HA, Erzurum SA, Golden RP, Koutnik CA, Kuo AF, Lenhart PD, Mokka PL, Petersen DB, Ticho BH, Wiecek EK, Yin H, Beaulieu WT, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Baseline factors associated with myopia progression and axial elongation over 30 months in children 5 to 12 years of age. Optom Vis Sci. 2024 Oct 1;101(10):619-626. doi: 10.1097/OPX.0000000000002187.
PubMed 39480129

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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)
ClinicalTrials.gov ID: NCT03334253
Acronym / sponsor ID: MTS1 / MTS1
Conditions: Myopia
Keywords: Myopia, atropine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Jaeb Center for Health ResearchUniversity, hospital or other
Collaborators: Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Study start: 1 Jun 2018 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 12 Sep 2022 (actual)
First posted: 7 Nov 2017 (actual)
Results: Posted 11 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study Objectives

The objectives for this randomized trial are:

To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).
To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Detailed description

Study Objectives

The objectives for this randomized trial are:

To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).
To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Arm	Type	Receives
Atropine Group	Experimental	Drug: Atropine0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Placebo Group	Placebo comparator	Other: Placebo EyedropsPlacebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (12 listed)

Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
Refractive error meeting the following by cycloplegic autorefraction:
Gestational age ≥ 32 weeks.
Birth weight >1500g.
Parent understands the protocol and is willing to accept randomization to atropine or placebo.

Key exclusion criteria (10 listed)

Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
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.
Known atropine allergy.
Abnormality of the cornea, lens, central retina, iris or ciliary body.

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
AtropineAlso: Low-Dose AtropineDaily 0.01% atropine eyedrops	Drug	Atropine Group
Placebo EyedropsDaily placebo eyedrops	Other	Placebo Group

Primary outcome

Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
Time frame: At 24 months
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome Measure Stratified by Sex
Time frame: at 24 months
NIH-required analysis. Primary outcome measure (stratified by sex): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome Measure Stratified by Race
Time frame: by 24 months
NIH-required analysis. Primary outcome measure (stratified by race): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome Measure Stratified by Ethnicity
Time frame: at 24 months
NIH-required analysis. Primary outcome measure (stratified by ethnicity): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months.
Primary Outcome: Mean Change in Spherical Equivalent Refractive Error at 24 Months
Time frame: 24 months
The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis.

1 secondary outcome

Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
Time frame: At 30 months

Results and safety

Results posted to the registry on 11 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atropine Group	125	118
Placebo Group	62	57

Primary outcome: Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.

Time frame: At 24 months. Count of participants. Unit: Participants

Measure	Atropine Group n = 119	Placebo Group n = 58
<=-3.50 Diopters	0	0
>-3.50 to -3.00 Diopters	1	0
>-3.00 to -2.50 Diopters	1	0
>-2.50 to -2.00 Diopters	5	2
>-2.00 to -1.50 Diopters	8	7
>-1.50 to -1.00 Diopters	19	9
>-1.00 to -0.50 Diopters	37	18
>-0.50 to 0.00 Diopters	46	18

Atropine Group vs Placebo Group: Adjusted mean difference: -0.02 (95% CI -0.19 to 0.15)

Primary outcome: Primary Outcome Measure Stratified by Sex

Time frame: at 24 months. Mean (Standard Deviation). Unit: Diopters

Measure	Atropine Group n = 119	Placebo Group n = 58
Female	-0.74 (0.57)	-0.74 (0.70)
Male	-0.84 (0.70)	-0.75 (0.44)

Population analysed: 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit.

Primary outcome: Primary Outcome Measure Stratified by Race

Time frame: by 24 months. Mean (Standard Deviation). Unit: Diopter

Measure	Atropine Group n = 119	Placebo Group n = 58
White	-0.67 (0.55)	-0.74 (0.52)
Black/African American	-0.84 (0.63)	-1.07 (0.74)
Asian	-1.18 (0.80)	-0.26 (0.51)
More than one race	-0.84 (0.68)	-0.61 (0.58)
Unknown/not reported	-0.10	–

Population analysed: 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit.

Primary outcome: Primary Outcome Measure Stratified by Ethnicity

Time frame: at 24 months. Mean (Standard Deviation). Unit: Diopters

Measure	Atropine Group n = 119	Placebo Group n = 58
Not Hispanic or Latino	-0.81 (0.66)	-0.78 (0.62)
Hispanic or Latino	-0.63 (0.44)	-0.54 (0.42)

Population analysed: 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the duration of the study, baseline to 30 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atropine Group	2 of 125 (1.6%)	109 of 125 (87.2%)	0 of 125
Placebo Group	0 of 62 (0%)	56 of 62 (90.3%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37440213Repka MX, Weise KK, Chandler DL, Wu R, Melia BM, Manny RE, Kehler LAF, Jordan CO, Raghuram A, Summers AI, Lee KA, Petersen DB, Erzurum SA, Pang Y, Lenhart PD, Ticho BH, Beck RW, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Aug 1;141(8):756-765. doi: 10.1001/jamaophthalmol.2023.2855.
Derived from this study: PubMed 39480129Weise KK, Repka MX, Zhu Y, Manny RE, Raghuram A, Chandler DL, Summers AI, Lee KA, Kehler LAF, Pang Y, Allen MS, Anderson HA, Erzurum SA, Golden RP, Koutnik CA, Kuo AF, Lenhart PD, Mokka PL, Petersen DB, Ticho BH, Wiecek EK, Yin H, Beaulieu WT, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Baseline factors associated with myopia progression and axial elongation over 30 months in children 5 to 12 years of age. Optom Vis Sci. 2024 Oct 1;101(10):619-626. doi: 10.1097/OPX.0000000000002187.
Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.

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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.

Michael X Repka, MD, MBA study chair

Wilmer Eye Institute

Katherine K Weise, OD, MBA study chair

University of Alabama Birmingham Pediatric Eye Care, Birmingham Health Care

13 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 in people with Myopia, run by Jaeb Center for Health Research at 13 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 12 inclusion and 10 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 31 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 13 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?

Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. (time frame: At 24 months). The study lists 5 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 NCT03334253, which also lists 2 linked publications.

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 31 Jul 2026.