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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Orthokeratology

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Shuang yin, MD; Phone Number: +8627306525; Email: yins2020@126.com

Study Locations

• China
  • Tianjin, China, 300020
    • Recruiting
    • Tianjin Eye Hospital
    • Contact: Shuang yin, MD; Phone Number: +8627306525; Email: yins2020@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged 8-18 years with normal eye health

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental Group; Subjects wore orthokeratology lenses	Device: Orthokeratology; The experimental group wore orthokeratology lenses
Control group; Subjects wore single-vision glasses group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KY2023032