The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children

Myopia Clinical Trial

Official title:

The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956717
• Other study ID #: KY2023032
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: Tianjin Eye Hospital
• Contact: shuang yin, MD
• Phone: +8627306525
• Email: yins2020[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the EQ-5D-Y, CHU9D, and CHROME-G scales with the use of a self-assessment method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Spherical equivalent ranged -1.00D from-5.00D

• Optimal corrected visual acuity =1.0 in both eyes

• No apparent strabismus or other eye disease

• Able to read Chinese and communicate in Mandarin, able to understand the questions in the questionnaire

Exclusion Criteria:

• A history of corneal surgery within 1 year

• Eyelid abnormalities or infection

• An inability to wear orthokeratology

• Use medications that affect the wear of eye and corneal contact lenses

• Those who have participated in a clinical trial of a drug within 90 days

• Allergic patients who have used contact lenses and/or care products

• The researchers consider it inappropriate to participate in this program

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Orthokeratology
The experimental group wore orthokeratology lenses

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score	The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.	The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
Primary	Changes in the Child Health Utility 9D (CHU9D) score	The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.	The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology