Myopia Progressing
Conditions
Brief summary
This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.
Interventions
DEVICEDefocus microlenses
Different microlenses array (H.M.E.C，High Precision Micro Encircle and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 6-14 years old; 2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50D\ -4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0; 3. Within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used; 4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Exclusion criteria
1. Diagnosed constant strabismus; 2. Diagnosed pathological myopia; 3. Other congenital eye diseases; 4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective refraction equivalent spherical | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Axial length | 2 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other biological parameters | 2 years | amplitude of accommodation, anterior chamber depth, corneal curvature, white to white distance, central corneal thickness, lens thickness ,pupil size, multispectral refraction topography, choroidal thickness, objective visual quality, wavefront aberration, contrast sensitivity, and strabismus (mahalanobis bar method). |
| Best corrected visual acuity | 2 years | — |
| questionnaires of daily eye habits and wearing time of subjects collected | 2 years | — |
Countries
China
Outcome results
None listed