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NCT03949101
Atropine for Children and Adolescent Myopia Progression Study
Phase 4 trial testing Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop in Myopia in 222 participants. Status unknown.
8 May 2021
Quick facts
| Lead sponsor | Shanghai Eye Disease Prevention and Treatment Center |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 222 |
| Start date | 8 May 2019 |
| Primary completion | 8 May 2021 |
| Estimated completion | 1 September 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop — full drug profile →
- atropine 0.01% eye drop
Conditions studied
- Myopia — all drugs for Myopia →
Sponsor
Shanghai Eye Disease Prevention and Treatment Center — full company profile →
Who can join
Adults 7 to 12, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Investigators are going to conduct a randomized controlled trial that myopic children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group) in order to explore a better way to control myopia progression and eliminate adverse effects at the same time, provide reliably evidence for clinical guideline of atropine use in children, and investigate the mechanism of atropine on eyes.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interventions for myopia control in children: a living systematic review and network meta-analysis.
Lawrenson JG, Shah R, Huntjens B, Downie LE, et al · · 2023 · cited 117× · PMID 36809645 · DOI 10.1002/14651858.cd014758.pub2 -
Effects of Atropine Treatment on Choroidal Thickness in Myopic Children.
Ye L, Shi Y, Yin Y, Li S, et al · · 2020 · cited 54× · PMID 33320168 · DOI 10.1167/iovs.61.14.15 -
Efficacy and Safety of Consecutive Use of 1% and 0.01% Atropine for Myopia Control in Chinese Children: The Atropine for Children and Adolescent Myopia Progression Study.
Ye L, Xu H, Shi Y, Yin Y, et al · · 2022 · cited 18× · PMID 36175821 · DOI 10.1007/s40123-022-00572-1 -
Potential Choroidal Mechanisms Underlying Atropine's Antimyopic and Rebound Effects: A Mediation Analysis in a Randomized Clinical Trial.
Xu H, Ye L, Peng Y, Yu T, et al · · 2023 · cited 14× · PMID 37043339 · DOI 10.1167/iovs.64.4.13 -
Comparison of the influence of 1% and 0.01% atropine on the corneal topography in myopic children.
Zhao LQ, Ye LY, Chen J, Zhu XF, et al · · 2025 · PMID 41254600 · DOI 10.1186/s12886-025-04465-2
Verify or expand the search:
- PubMed search for NCT03949101
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Shanghai Eye Disease Prevention and Treatment Center trials
Trials by the same sponsor.
- NCT07535658 — Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control · NA · not yet recruiting
- NCT07514039 — Photolithography Microstructure Myopia Management Lenses in Preventing and Controlling Myopia in Children and Adolescent · NA · enrolling by invitation
- NCT07312214 — LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia · NA · recruiting
- NCT07284147 — 3D Designed Defocus Lenses on Myopia Control in Children and Adolescents · NA · enrolling by invitation
- NCT07120737 — Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX Technology on High Myopia Control in Children and Adolescents · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03949101 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Eye Disease Prevention and Treatment Center
- Last refreshed: 17 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03949101.
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