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

T

Tianjin Eye Hospital

Status

Enrolling

Conditions

Myopia

Treatments

Device: Orthokeratology

Study type

Observational

Funder types

Other

Identifiers

NCT05956717
KY2023032

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Experimental Group
Description:
Subjects wore orthokeratology lenses
Treatment:
Device: Orthokeratology
Control group
Description:
Subjects wore single-vision glasses group

Trial contacts and locations

1

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Central trial contact

shuang yin, MD

Data sourced from clinicaltrials.gov

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