Evidence map›Paper›PMID 41870844›Full record

ArticleOphthalmology and therapy2026

STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03.

Michael Korenfeld, Maria Hurcikova, Kay Tatsuoka, Dana Tomciková, Janet Cheetham, Marek Kacerik, STAR Study Investigators

Erratum issued Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03918915 (A Multicenter, Randomized, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03918915 phase3completednot on this map

A Multicenter, Randomized, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children

TypeinterventionalSponsorSydnexis, Inc.Ran2019 to 2025Enrolled852ConditionsNearsightedness, Near Sightedness, Near-sightednessArmsSYD-101 0.01%, SYD-101 0.03%, Vehicle
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Michael KorenfeldComprehensive Eye Care, Ltd, Washington, MO, USA.ORCID http://orcid.org/0000-0003-1804-5525
Maria HurcikovaDepartment of Ophthalmology, Nemocnica Penta Hospitals, Trebisov, Slovakia.ORCID http://orcid.org/0009-0000-1741-5067
Kay TatsuokaData Science, Santen Inc., Emeryville, CA, USA. Kay.Tatsuoka@santen.com.ORCID http://orcid.org/0000-0003-3487-6468
Dana TomcikováPediatric Ophthalmology Department, National Institute of Children's Diseases, Bratislava, Slovakia.ORCID http://orcid.org/0000-0002-9285-7065
Janet CheethamSydnexis Clinical Consultant, Laguna Niguel, CA, 92677, USA.ORCID http://orcid.org/0000-0003-4603-5375
Marek KacerikDepartment of Ophthalmology, Faculty Hospital, Trencin, Slovakia.ORCID http://orcid.org/0009-0003-3086-0677
STAR Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPediatric myopia is rising globally, with high myopia associated with sight-threatening complications later in life. Low-dose atropine has been shown to slow myopia progression, with most studies conducted in Asian populations using compounded formulations. We evaluated the efficacy and safety of atropine sulfate ophthalmic solution at two concentrations for slowing myopia progression in a predominantly white population.

methodsSTAR was a randomized, double-masked, vehicle-controlled, phase 3 clinical study conducted in Europe and the USA. Children (N = 847) aged 3-14 years with myopia between - 0.50 and - 6.00 diopters (D) were dosed after 1:1:1 randomization to vehicle, atropine sulfate 0.01% or 0.03% once daily before bedtime for 48 months. The primary endpoint was mean annual progression rate (APR) of myopia, measured by cycloplegic autorefraction, through month 24.

resultsMean APR at 24 months was - 0.44 D/year (vehicle), - 0.31 D/year (atropine sulfate 0.01%), and - 0.32 D/year (atropine sulfate 0.03%), with differences versus vehicle of 0.13 D (95% CI 0.06-0.20; p = 0.0003) and 0.12 D (95% CI 0.05-0.19; p = 0.0009), respectively. In Fast Progressor Subgroup 1 (progression - 0.50 D/year or worse at baseline), differences versus vehicle were 0.21 D (p < 0.0001) for atropine sulfate 0.01% and 0.15 D (p = 0.0023) for atropine sulfate 0.03%. In Fast Progressor Subgroup 2 (progression - 0.75 D/year or worse at baseline), differences versus vehicle were 0.19 D (p = 0.0008) for atropine sulfate 0.01% and 0.11 D (p = 0.0397) for atropine sulfate 0.03%. TEAEs were similar across groups. Photophobia was the most common ocular event (16.7% vehicle, 24.1% atropine sulfate 0.01%, 30.4% atropine sulfate 0.03%). Treatment discontinuation was similar across groups (18.7% vehicle, 19.7% atropine sulfate 0.01%, 18.6% atropine sulfate 0.03%).

conclusionAtropine sulfate 0.01% and 0.03% effectively slowed myopia progression in children, with greatest efficacy in Fast Progressors Subgroup 1. Both concentrations were well tolerated with manageable side effects, supporting atropine sulfate as a treatment option for pediatric myopia. CLINICAL

trial registrationClinicalTrials.gov identifier NCT03918915.

Indexed as

Annual progression rateAPRAtropine sulfate 0.01%Atropine sulfate 0.03%ChildrenLow-dose atropinePediatric myopiaSlowing of myopic progressionSpherical equivalent refractionSTAR

Identifiers

PMID41870844
PMCPMC13176443

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.