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

Myopia, Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405711
• Other study ID #: KY-2023036-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Tianjin Eye Hospital
• Contact: Xiaoqin Chen, MD
• Phone: +8618202681988
• Email: chenxq017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic objective refraction	Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan)	12 months
Secondary	Axial Length	Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan)	12 months