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

Tianjin Eye Hospital

Status: Active, not recruiting

Conditions: Myopia

Treatments: Device: Circular cylindrical mirror modulated frame glasses (strong defocus); Device: single vision frame glasses; Device: Circular cylindrical mirror modulated frame glasses (compact)

Study type: Interventional

Funder types: Other

Identifiers

NCT05288335

TianjinEH-myopia progression

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 3 patient groups

Circular cylindrical mirror modulated frame glasses (compact)

Experimental group

Description:

Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.

Treatment:

Device: Circular cylindrical mirror modulated frame glasses (compact)

Circular cylindrical mirror modulated frame glasses (strong defocus)

Experimental group

Description:

Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.

Treatment:

Device: Circular cylindrical mirror modulated frame glasses (strong defocus)

single vision frame glasses

Experimental group

Description:

Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.

Treatment:

Device: single vision frame glasses