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

NCT ID: NCT05956717

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-10-01

Brief Summary

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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

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Conditions

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Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental Group

Subjects wore orthokeratology lenses

Orthokeratology

Intervention Type DEVICE

The experimental group wore orthokeratology lenses

Control group

Subjects wore single-vision glasses group

No interventions assigned to this group

Interventions

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Orthokeratology

The experimental group wore orthokeratology lenses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Eye Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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shuang yin, MD

Role: CONTACT

+8627306525

Facility Contacts

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Shuang yin, MD

Role: primary

+8627306525

Other Identifiers

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KY2023032

Identifier Type: -

Identifier Source: org_study_id

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