Corneal Biomechanics and Corneal Reshaping Therapy

March 30, 2020 updated by: The Hong Kong Polytechnic University

Corneal Stiffness and Tangent Modulus to Predict the Rate of Corneal Curvature Change in Corneal Reshaping Therapy

The aim of the proposed study is to investigate the predictive value of corneal biomechanical properties in corneal reshaping therapy and the role of these parameters in determining the amount of myopia reduction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Experiment 1: To evaluate changes in corneal biomechanics caused by short-term corneal reshaping therapy.

Subjects will wear a conventional RGP lens in one eye, randomly selected, and an orthokeratology lens in the fellow eye, for 30 minutes, 60 minutes and one night, respectively. Corneal stiffness and tangent modulus will be measured before and after each wearing period.

Experiment 2: To evaluate changes in and the recovery of corneal biomechanics effected by long-term corneal reshaping and to assess whether corneal biomechanics can predict the rate of corneal reshaping.

Subjects will wear orthokeratology lenses for 6 months. Regular follow up visits (1 week, 1 month, 3 months and 6 months) will be arranged to monitor the changes in corneal stiffness and tangent modulus.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

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

  • Hong Kong
      • Kowloon, Hong Kong, HKG
        • The Hong Kong Polytechnic University

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Myopia between -4D to -5D, with-the-rule astigmatism not more than 1.5D, spherical equivalent between -4D to -5.75D, difference between two eyes within 1D, best corrected spectacle visual acuity 0.10 logMAR in each eye

Exclusion Criteria:

  • previous corneal reshaping therapy, long-term contact lens wear, ocular disease

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corneal reshaping therapy
Subjects will be wearing corneal reshaping lenses for the correction of their myopia
Other: Corneal reshaping therapy
Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Corneal Stiffness From Baseline at 6 Months
Time Frame: At baseline, then change from baseline to 6 months
Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.
At baseline, then change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Tangent Modulus From Baseline at 6 Months
Time Frame: At baseline, then change from baseline to 6 months
Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.
At baseline, then change from baseline to 6 months

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Andrew KC Lam, PhD, The Hong Kong Polytechnic University

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

January 1, 2016

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-Q46G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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