NCT02719535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

January 18, 2016

Results QC Date

February 13, 2020

Last Update Submit

March 30, 2020

Conditions

Myopia

Keywords

corneal reshaping therapycorneal biomechanics

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline, then change from baseline to 6 months

Secondary Outcomes (1)

  • Change of Tangent Modulus From Baseline at 6 Months

    At baseline, then change from baseline to 6 months

Study Arms (1)

Corneal reshaping therapy

EXPERIMENTAL

Subjects will be wearing corneal reshaping lenses for the correction of their myopia

Other: Corneal reshaping therapy

Interventions

Corneal reshaping therapyOTHER

Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses

Corneal reshaping therapy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, HKG, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Dr. Andrew Lam
Organization
The Hong Kong Polytechnic University
andrew.kc.lam@polyu.edu.hk
85227666109

Study Officials

  • Andrew KC Lam, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

March 25, 2016

Study Start

January 1, 2016

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

April 13, 2020

Results First Posted

April 13, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)