Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 15
Healthy Volunteers: f
View:
• Aged 8-15 years old.
• Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D.
• Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
• Bilateral intra-ocular pressure \< 21mmHg.
• Normal binocular and stereoscopic visual function.
• Participants and their guardians' understanding and acceptance of random allocation of grouping.
Locations
Other Locations
China
Zhongshan Ophthalmic Center Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yin Hu, Doctor
eddy06980094@163.com
86-18664783831
Backup
Xiao Yang, Professor
yangx_zoc@163.com
86-13760766303
Time Frame
Start Date: 2024-09-21
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 194
Treatments
Experimental: Ortho-k and 0.01% atropine sequential treatment
Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
Active_comparator: Ortho-k continuous treatment
Participants will be treated with ortho-k lenses throughout, during the 2-year study period.
Related Therapeutic Areas
Sponsors
Collaborators: Henan Provincial People's Hospital, Tianjin Medical University Eye Hospital, People's Hospital of Guangxi
Leads: Zhongshan Ophthalmic Center, Sun Yat-sen University