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

November 22, 2022 updated by: Tianjin Eye Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Tiajin Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Myopia with orthokeratology lens and complete follow-up.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
1
8-12 years old
2
13-16 years old
3
over 16 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The change of baseline and 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of axial length
Time Frame: The change of baseline and 6 months
The axial length was measured by AL-scan
The change of baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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