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

Sponsor

Tianjin Eye Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05956717

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Orthokeratology

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental Group

Subjects wore orthokeratology lenses

Device: Orthokeratology

The experimental group wore orthokeratology lenses

Control group

Subjects wore single-vision glasses group

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Eye Hospital	Tianjin		China	300020

Sponsors and Collaborators

Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Eye Hospital

ClinicalTrials.gov Identifier:

NCT05956717

Other Study ID Numbers:

KY2023032

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Study Results

No Results Posted as of Jul 21, 2023