To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia
NCT06405711 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2024-05-08
Summary
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.
Conditions
- Myopia, Progressive
Interventions
- DEVICE
-
frame lens
A randomized block group design was used to randomly assign the included study subjects. The appropriate randomization number and random allocation scheme will be given after enrollment.
Sponsors & Collaborators
-
Tianjin Eye Hospital
lead OTHER
Principal Investigators
-
Xiaoqin Chen, MD · Tianjin Eye Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-31
- Primary Completion
- 2026-05-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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