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

Recruiting

• Conditions: Myopia
• Interventions: Device: Orthokeratology

• Registration Number: NCT05956717
• Lead Sponsor: Tianjin Eye Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	Orthokeratology	Subjects wore orthokeratology lenses

Primary Outcome Measures

Name	Time	Method
Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score	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	The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
Changes in the Child Health Utility 9D (CHU9D) score	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	The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China