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A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The research project titled A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 90 children aged 8-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:

• Children aged 7-17 years.

• Myopia between -1.00D and -6.00D; astigmatism \<±1.5D; best corrected visual acuity ≥1.0.

• First-time spectacle wearers who use a single correction method and meet the indications for it (any one of orthokeratology lenses, single-vision frame glasses, or myopia control frame glasses)

• Willing to participate in the entire research process and complete all the examinations, questionnaires and cost records as required.

• Be able to maintain contact throughout the research period, such as having a fixed address and contact information.

Locations
Other Locations
China
HeEyeHospital
RECRUITING
Shenyang
Contact Information
Primary
lan Hu
hulan@hsyk.com.cn
+8615940406919
Backup
ruyi Li
liruyi202202@163.com
+8615754717553
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 90
Treatments
Control Group1
This group includes children and adolescents who are correcting myopia using peripheral defocus spectacles. These spectacles are a novel corrective measure, designed to control myopia progression by creating a defocus zone around the periphery of the lenses.
Control Group2
This group consists of children and adolescents using orthokeratology lenses for myopia correction. Orthokeratology lenses are specially designed rigid contact lenses worn overnight to temporarily reshape the cornea, aiming to reduce dependency on glasses or contact lenses during the day.
Control Group3
This group includes children and adolescents who are using standard single-vision frame glasses for myopia correction.
Related Therapeutic Areas
Sponsors
Leads: He Eye Hospital

This content was sourced from clinicaltrials.gov