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

Tianjin Eye Hospital

Status: Not yet enrolling

Conditions: Myopia, Progressive

Treatments: Device: frame lens

Study type: Interventional

Funder types: Other

Identifiers

NCT06405711

KY-2023036-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

138 participants in 3 patient groups

Test group A (strong higher-order aberrations group)

Experimental group

Description:

Simultaneous myopic defocus and strong higher-order aberrations lenses

Treatment:

Device: frame lens

Test group B (medium higher-order aberrations group)

Experimental group

Description:

Both myopic defocus and medium higher-order aberrations lenses

Treatment:

Device: frame lens

control groups（HOYA MiYOSMART）

Active Comparator group

Description:

HOYA MiYOSMART lenses

Treatment:

Device: frame lens