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

NCT ID: NCT06405711

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-12-31

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.

Conditions

Myopia, Progressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Test group A (strong higher-order aberrations group)

Simultaneous myopic defocus and strong higher-order aberrations lenses

Group Type: EXPERIMENTAL

frame lens

Intervention Type: DEVICE

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.

Test group B (medium higher-order aberrations group)

Both myopic defocus and medium higher-order aberrations lenses

Group Type: EXPERIMENTAL

frame lens

Intervention Type: DEVICE

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.

control groups（HOYA MiYOSMART）

HOYA MiYOSMART lenses

Group Type: ACTIVE_COMPARATOR

frame lens

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoqin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Eye Hospital

Locations

Tianjin Eye Hospital

Tianjin, , China

Countries

China

Central Contacts

Xiaoqin Chen, MD

Role: CONTACT

chenxq017@163.com

+8618202681988

Facility Contacts

xiaoqin Chen

Role: primary

chenxq017@163.com

+8618202681988

Other Identifiers

KY-2023036-2

Identifier Type: -

Identifier Source: org_study_id