Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Tianjin Eye Hospital
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Changes in ocular axial length in a year
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •6-13 years old;
- •SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
- •Monocular best corrected visual acuity (VA) of 1.0 or better;
- •Acceptance of random group allocation and the masked study design
- •Voluntarily participate in the clinical trial and sign the informed consent;
Exclusion Criteria
- •Strabismus.
- •Ocular and systemic abnormalities.
- •Prior experience of myopia control.
- •Only one eye meets the inclusion criteria.
Arms & Interventions
Circular cylindrical mirror modulated frame glasses (compact)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.
Intervention: Circular cylindrical mirror modulated frame glasses (compact) (Device)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
Intervention: Circular cylindrical mirror modulated frame glasses (strong defocus) (Device)
single vision frame glasses
Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
Intervention: single vision frame glasses (Device)
Outcomes
Primary Outcomes
Changes in ocular axial length in a year
Time Frame: baseline, 12 months
The ocular axial length was measured by AL-scan
Secondary Outcomes
- Changes in cycloplegic objective spherical equivalent in a year(baseline, 12 months)