Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology

Completed

• Conditions: Myopia; Orthokeratology

• Registration Number: NCT05635526
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Detailed Description

The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups: Ⅰ (8-12 years old), Ⅱ (13-16 years old), Ⅲ (over 16 years old). The OK lenses used in the present study are of the same design (Euclid Systems Orthokeratology; Euclid System, Herndon, VA, USA). The base line (Day 0) and different follow-up time point (Day 1, Week 1, Week 2, Month 1, Month 3, and Month 6) of dynamic corneal response (DCR) (including 19 items) of the patients derived by Corvis ST were collected. The difference between before and after wearing OK Lens and the changes of parameters among the three groups were both analyzed. And the correlation between axis length (AL) and the 19 parameters also was analyzed. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-06-01
• Status Verified: 2022-10
• Study Completion: 2022-10-01
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• age from 8 to 40 years old
• spherical equivalent(SE) was range from -1.00D to -5.00D
• conform to the standard of wearing orthokeratology lens

Exclusion Criteria

• ocular diseases and systemic diseases
• visual acuity was less than 20/20
• unable to follow visitors on time

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of dynamic corneal response (DCR)	The change of baseline and 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months	The axial length was measured by Corvis ST

Secondary Outcome Measures

Name	Time	Method
The change of axial length	The change of baseline and 6 months	The axial length was measured by AL-scan

Trial Locations

Locations (1)

Tiajin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China