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NCT06411717

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

A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Suzhou Kerui Medical Technology Co., Ltd·ClinicalTrials.gov·device·Device trialRecruiting
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Study focus
Disease/Condition
Myopia
Drug/Device/Intervention
Microstructure lens A
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Suzhou Kerui Medical Technology Co., Ltd
Location
Suzhou, China
Timeline & enrollment
Phase
N/A
Start date
Apr 07, 2024
End date
Mar 07, 2026
Enrollment
156 participants
Primary outcome

Change value of equivalent spherical lens after cycloplegia (subjective refraction)

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.

ICD-10 classifications
MyopiaDegenerative myopiaAmblyopia ex anopsiaOcular myiasisMyiasis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06411717
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06411717 through Pure Global AI's free database. This phase not specified trial is sponsored by Suzhou Kerui Medical Technology Co., Ltd and is currently Recruiting. The study focuses on Myopia. Target enrollment is 156 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.