Crossover RCT of TAMER Lenses in Myopia Control

A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia; Progressive
• Intervention / Treatment: Device: TAMER Lens Spectacle; Device: SV lenses

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangui He; Phone Number: 021-62982727-817; Email: dllcrco@shsyf.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200041
      • Recruiting
      • Shanghai Eye Disease Prevention and Treatment Center
      • Contact: Xiangui He; Phone Number: 021-62982727-817

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.	Device: TAMER Lens Spectacle; Regular daily wear of TAMER lens spectacle; Device: SV lenses; SV lenses
Experimental: Group B; SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.	Device: TAMER Lens Spectacle; Regular daily wear of TAMER lens spectacle; Device: SV lenses; SV lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical Equivalent change	cycloplegic SE change	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Axial Length change	6 months
Spherical Equivalent change	12 months

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SEDPTC20240109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No