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

NCT05956717 | Unknown DMC

• 1 other identifier: KY2023032
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental Group

Subjects wore orthokeratology lenses

Device: Orthokeratology

Control group

Subjects wore single-vision glasses group

Interventions

Orthokeratology DEVICE

The experimental group wore orthokeratology lenses

Experimental Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged 8-18 years with normal eye health

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, 300020, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

shuang yin, MD

CONTACT

+8627306525; yins2020@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: October 1, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

CN (1)