Back to resultsCorneal Biomechanics and Corneal Reshaping Therapy
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Corneal reshaping therapy
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring corneal reshaping therapy, corneal biomechanics
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
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Corneal reshaping therapy
Arm Description
Subjects will be wearing corneal reshaping lenses for the correction of their myopia
Outcomes
Primary Outcome Measures
Change of Corneal Stiffness From Baseline at 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
Change of Tangent Modulus From Baseline at 6 Months
Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.
Full Information
NCT ID
NCT02719535
First Posted
January 18, 2016
Last Updated
March 30, 2020
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT02719535
Brief Title
Corneal Biomechanics and Corneal Reshaping Therapy
Official Title
Corneal Stiffness and Tangent Modulus to Predict the Rate of Corneal Curvature Change in Corneal Reshaping Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
corneal reshaping therapy, corneal biomechanics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corneal reshaping therapy
Arm Type
Experimental
Arm Description
Subjects will be wearing corneal reshaping lenses for the correction of their myopia
Intervention Type
Other
Intervention Name(s)
Corneal reshaping therapy
Intervention Description
Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses
Primary Outcome Measure Information:
Title
Change of Corneal Stiffness From Baseline at 6 Months
Description
Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.
Time Frame
At baseline, then change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Change of Tangent Modulus From Baseline at 6 Months
Description
Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.
Time Frame
At baseline, then change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew KC Lam, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Kowloon
ZIP/Postal Code
HKG
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Corneal Biomechanics and Corneal Reshaping Therapy
We'll reach out to this number within 24 hrs