Myopia, Progressive Clinical Trial
Official title:
To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia:a Prospective Study
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective, single-centre, randomised, double-blind, controlled, non-inferiority clinical study.
Status | Not yet recruiting |
Enrollment | 138 |
Est. completion date | December 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 13 Years |
Eligibility | Inclusion Criteria: - The subjects had spherical RE of -1.00 to -6.00 D, astigmatism = 1.50 D, anisometropia = 1.50 D - the best corrected visual acuity in the left and right eyes subjective optometry is greater than or equal to 1.0 Exclusion Criteria: - Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Eye Hospital | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Eye Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cycloplegic objective refraction | Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan) | 12 months | |
Secondary | Axial Length | Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan) | 12 months |
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