Observing the impact of orthokeratology on myopic children's quality of life and behavior
The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children
This study is testing how wearing special contact lenses at night affects the daily life and behavior of kids and teens aged 8 to 18 with nearsightedness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Tianjin Eye Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05956717 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of orthokeratology on the quality of life and behavior of children and adolescents aged 8 to 18 years with myopia. Participants will be evaluated before and after undergoing orthokeratology treatment, using self-assessment scales such as EQ-5D-Y, CHU9D, and CHROME-G. The study will also compare the differences in quality of life and behaviors among various myopic groups following keratoplasty. The goal is to gather insights into how this treatment influences daily life and eye habits in young patients.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 8-18 years with myopia ranging from -1.00D to -5.00D and optimal corrected visual acuity.
Not a fit: Patients with a history of corneal surgery within the past year or those unable to wear orthokeratology lenses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how orthokeratology improves the quality of life and behavioral outcomes for myopic children.
How similar studies have performed: While there is limited data on similar observational studies, the approach of assessing quality of life and behavior changes in myopic children through orthokeratology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin
- Tianjin Eye Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: shuang yin, MD
- Email: yins2020@126.com
- Phone: +8627306525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.