Crossover RCT of TAMER Lenses in Myopia Control

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329986
• Other study ID #: SEDPTC20240109
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2024
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Xiangui He
• Phone: 021-62982727-817
• Email: dllcrco[@]shsyf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• TAMER Lens Spectacle
Regular daily wear of TAMER lens spectacle
• SV lenses
SV lenses

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical Equivalent change	cycloplegic SE change	6 months
Secondary	Axial Length change		6 months
Secondary	Spherical Equivalent change		12 months