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

Not Applicable

Not yet recruiting

• Conditions: Myopia, Progressive
• Interventions: Device: frame lens

• Registration Number: NCT06405711
• Lead Sponsor: Tianjin Eye Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control groups（HOYA MiYOSMART）	frame lens	HOYA MiYOSMART lenses
Test group A (strong higher-order aberrations group)	frame lens	Simultaneous myopic defocus and strong higher-order aberrations lenses
Test group B (medium higher-order aberrations group)	frame lens	Both myopic defocus and medium higher-order aberrations lenses

Primary Outcome Measures

Name	Time	Method
Cycloplegic objective refraction	12 months	Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan)

Secondary Outcome Measures

Name	Time	Method
Axial Length	12 months	Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan)

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China