NCT06405711

To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia

To Evaluate the Efficacy and Safety of an Defocus Lens in Slowing the Progression of Myopia：a Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

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.

Detailed description

Prior to the trial, subjects signed an informed consent form, screened and qualified subjects were enrolled, and subjects received framed spectacles for correction of myopic refractive error in both eyes, and were fitted with framed spectacles by the investigator according to the standard fitting procedure specified in this protocol. Subjects were randomized to Trial Group A (strong high order aberration group) and Trial Group B (medium high order aberration group) and Control Group (HOYA MiYOSMART). The index of effectiveness in this clinical trial was to assess the effectiveness of the test group of lenses in slowing the rate of myopia progression by examining the subject's objective optometric values after ciliary muscle paralysis. The basic examination of this clinical trial included slit lamp examination, eye axis examination, fundus examination, corneal topography, best-corrected visual acuity, binocular visual function, refractive status and best-corrected visual acuity after ciliary muscle paralysis, and intraocular pressure measurements, etc. The spectacle fitting was also recorded, as well as the subjective feeling of the subjects when wearing the lenses. Each subject was followed up for 12 months, and the efficacy and safety of the test product for delaying the progression of myopia was evaluated by the investigator at 1 week ± 1 day (telephone follow-up), 1 month ± 15 days (telephone follow-up), 3 months ± 15 days, 6 months ± 15 days, and 12 months ± 30 days after wearing the lenses. During the course of this clinical trial, the lenses were replaced due to loss, breakage, change in refraction or poor vision with the lenses, etc., after evaluation by the investigator, and the changes were recorded.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: China