Corneal Biomechanics and Corneal Reshaping Therapy

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Other: Corneal reshaping therapy

• Registration Number: NCT02719535
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Status Verified: 2018-02
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Results First Submitted: 2020-02-13
• Results First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Results First Posted: 2020-04-13
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corneal reshaping therapy	Corneal reshaping therapy	Subjects will be wearing corneal reshaping lenses for the correction of their myopia

Primary Outcome Measures

Name	Time	Method
Change of Corneal Stiffness From Baseline at 6 Months	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 Outcome Measures

Name	Time	Method
Change of Tangent Modulus From Baseline at 6 Months	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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Kowloon, Hong Kong