Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05288335

Enrollment

240

Registered

2022-03-21

Start date

2022-05-01

Completion date

2024-12-31

Last updated

2022-12-28

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

Conditions

Myopia

Brief summary

Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Detailed description

Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively. Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Interventions

DEVICECircular cylindrical mirror modulated frame glasses (compact)

Circular cylindrical mirror modulated frame glasses (compact)

DEVICECircular cylindrical mirror modulated frame glasses (strong defocus)

Circular cylindrical mirror modulated frame glasses (strong defocus)

DEVICEsingle vision frame glasses

single vision frame glasses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 13 Years

Healthy volunteers

Yes

Inclusion criteria

1. 6-13 years old; 2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less; 3. Monocular best corrected visual acuity (VA) of 1.0 or better; 4. Acceptance of random group allocation and the masked study design 5. Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion criteria

1. Strabismus. 2. Ocular and systemic abnormalities. 3. Prior experience of myopia control. 4. Only one eye meets the inclusion criteria.

Design outcomes

Primary

Measure	Time frame	Description
Changes in ocular axial length in a year	baseline, 12 months	The ocular axial length was measured by AL-scan

Secondary

Measure	Time frame	Description
Changes in cycloplegic objective spherical equivalent in a year	baseline, 12 months	The cycloplegic objective spherical equivalent was evaluated by a autorefractor

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026