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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Shanghai Eye Disease Prevention and Treatment Center
RECRUITING
Shanghai
Contact Information
Primary
Xiangui He
dllcrco@shsyf.com
021-62982727-817
Time Frame
Start Date: 2024-02-24
Estimated Completion Date: 2026-01
Participants
Target number of participants: 120
Treatments
Experimental: Group A
TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.
Experimental: Group B
SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Eye Disease Prevention and Treatment Center

This content was sourced from clinicaltrials.gov

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