Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-03-06 @ 4:56 PM
Study NCT ID:
NCT02719535
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2016-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Corneal Biomechanics and Corneal Reshaping Therapy
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
Corneal Stiffness and Tangent Modulus to Predict the Rate of Corneal Curvature Change in Corneal Reshaping Therapy
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: