Crossover RCT of TAMER Lenses in Myopia Control

NCT06329986 | Unknown

• 1 other identifier: SEDPTC20240109
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Progressive

Outcome Measures

Primary Outcomes (1)

• Spherical Equivalent change

  cycloplegic SE change

  6 months

Secondary Outcomes (2)

• Axial Length change

  6 months

• Spherical Equivalent change

  12 months

Study Arms (2)

Group A

EXPERIMENTAL

TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.

Device: TAMER Lens Spectacle; Device: SV lenses

Group B

EXPERIMENTAL

SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.

Device: TAMER Lens Spectacle; Device: SV lenses

Interventions

TAMER Lens Spectacle DEVICE

Regular daily wear of TAMER lens spectacle

Group A; Group B

SV lenses DEVICE

SV lenses

Group A; Group B

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200041, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Xiangui He

CONTACT

021-62982727-817; dllcrco@shsyf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 26, 2024
• Study Start: February 24, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 26, 2024

Record last verified: 2024-01

Locations

CN (1)