Crossover RCT of TAMER Lenses in Myopia Control

Not Applicable

Recruiting

• Conditions: Myopia; Progressive
• Interventions: Device: TAMER Lens Spectacle; Device: SV lenses

• Registration Number: NCT06329986
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-01
• Study Start: 2024-02-24
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Race: Chinese children and adolescents.
• Age 6-12 years, gender unrestricted.
• Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
• Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
• Cylinder power and astigmatism are no more than 1.5D.
• During the study period, willing to wear glasses provided by the researcher only and without additional interventions.
• Willing to be randomly assigned.
• Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.

Exclusion Criteria

• Allergic or intolerant to medications used for cycloplegia.
• Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
• Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
• History of eye surgery (including strabismus correction surgery).
• Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
• Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
• Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	TAMER Lens Spectacle	TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.
Group A	SV lenses	TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.
Group B	SV lenses	SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.
Group B	TAMER Lens Spectacle	SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.

Primary Outcome Measures

Name	Time	Method
Spherical Equivalent change	6 months	cycloplegic SE change

Secondary Outcome Measures

Name	Time	Method
Axial Length change	6 months
Spherical Equivalent change	12 months

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center; 🇨🇳 Shanghai, Shanghai, China