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A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression - Trial NCT06411717

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT06411717
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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

Study Focus

Myopia

Microstructure lens A

Interventional

device

Sponsor & Location

Suzhou Kerui Medical Technology Co., Ltd

Suzhou, China

Timeline & Enrollment

N/A

Apr 07, 2024

Mar 07, 2026

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

Myopia
Degenerative myopia
Amblyopia ex anopsia
Ocular myiasis
Myiasis

Data Source

ClinicalTrials.gov

NCT06411717

Device Trial