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Clinical Trials/NCT02719535
NCT02719535
Completed
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country59 target enrollmentJanuary 2016
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
The Hong Kong Polytechnic University
Enrollment
59
Locations
1
Primary Endpoint
Change of Corneal Stiffness From Baseline at 6 Months
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
September 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change of Tangent Modulus From Baseline at 6 Months(At baseline, then change from baseline to 6 months)

Study Sites (1)

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