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A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression

NCT06411717 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-05-14

No results posted yet for this study

Summary

The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.

Conditions

  • Myopia

Interventions

DEVICE

Microstructure lens A

Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months

DEVICE

Microstructure lens B

Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months

OTHER

Control group

Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months

Sponsors & Collaborators

  • Suzhou Mingshi Optical Technology Co., Ltd

    collaborator UNKNOWN

  • Suzhou Kerui Medical Technology Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-07
Primary Completion
2025-11-07
Completion
2026-03-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411717 on ClinicalTrials.gov