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OpenTrials
Completed

NCT Number: NCT05635526

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

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.

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Key information

Age range

8 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tiajin Eye Hospital

Tianjin, Tianjin Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The change of dynamic corneal response (DCR)

    Time frame: 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 outcomes

  1. The change of axial length

    Time frame: The change of baseline and 6 months

    The axial length was measured by AL-scan

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 2, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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