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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635526
• Other study ID #: 2022049
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Orthokeratology

Locations

Country	Name	City	State
China	Tiajin Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of dynamic corneal response (DCR)	The axial length was measured by Corvis ST	The change of baseline and 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months
Secondary	The change of axial length	The axial length was measured by AL-scan	The change of baseline and 6 months