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Efficacy and Safety of 0.01% Atropine and Novel Lenslet-ARray-Integrated Spectacle Lenses for Prevention of Myopia Shift and Myopia Onset in Premyopia Children

Efficacy and Safety of 0.01% Atropine and Novel Lenslet-ARray-Integrated Spectacle Lenses for Prevention of Myopia Shift and Myopia Onset in Premyopia Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098887
Enrollment
Unknown
Registered
2025-03-14
Start date
2024-08-23
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-myopia

Interventions

Group A:0.01% atropine eye drops group was simply given 0.01% atropine eye drops packed with unit dose and without preservatives, once a day, one drop at a time.
Group S:Group S was simply given novel Lenslet-ARray-Integrated spectacle lenses [Hexgon Optimized Reticular Intergration (H.O.R.I), manufacturer: Vision Eye Care Technology, Guangdong, China
registration number: 68736330] worn for 12 hours a day.
Group AS:The combination group was given the combined use of both.
Group E:No clinical intervention was given in the control group.

Sponsors

The Second Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were age 6–12 years, cycloplegic spherical equivalent refraction (SER)> - 0.75 D and = -3.00D.

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows: Astigmatism or anisometropia >=1.00D in both eyes; children with other combined ocular diseases (eg, amblyopia, strabismus, corneal scar, cataract, glaucoma, or ocular tumor); previous or current treatment with atropine, optical interventions or repeated low-level red-light for myopia control; and allergy to atropine; and inability to comply with the study visit schedule.

Design outcomes

Primary

MeasureTime frame
Incidence of myopia;spherical equivalent refraction (SER);

Secondary

MeasureTime frame
uncorrected visual activity (UCVA);axial length (AL) ;subfoveal choroidal thickness (SFCT) ;Intraocular pressure (IOP) ;

Countries

China

Contacts

Public ContactQi Zhao

The Second Hospital of Dalian Medical University

zhaoqidmu@126.com+86 133 0411 2073

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026