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

NCT06405711 | Not Yet Recruiting

• 1 other identifier: KY-2023036-2
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia, Progressive

Keywords

myopia; axial length; defocus

Outcome Measures

Primary Outcomes (1)

• Cycloplegic objective refraction

  Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan)

  12 months

Secondary Outcomes (1)

• Axial Length

  12 months

Study Arms (3)

Test group A (strong higher-order aberrations group)

EXPERIMENTAL

Simultaneous myopic defocus and strong higher-order aberrations lenses

Device: frame lens

Test group B (medium higher-order aberrations group)

EXPERIMENTAL

Both myopic defocus and medium higher-order aberrations lenses

Device: frame lens

control groups（HOYA MiYOSMART）

ACTIVE COMPARATOR

HOYA MiYOSMART lenses

Device: frame lens

Interventions

frame lens 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 A (strong higher-order aberrations group); Test group B (medium higher-order aberrations group); control groups（HOYA MiYOSMART）

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia, Degenerative; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Xiaoqin Chen, MD

  Tianjin Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqin Chen, MD

CONTACT

+8618202681988; chenxq017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)