Trial Outcomes & Findings for Corneal Biomechanics and Corneal Reshaping Therapy (NCT NCT02719535)

Last Updated: 2020-04-13

Results Overview

Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

59 participants

Primary outcome timeframe

At baseline, then change from baseline to 6 months

Results posted on

2020-04-13

Participant milestones
Measure	Corneal Reshaping Therapy Subjects will be wearing corneal reshaping lenses for the correction of their myopia Corneal reshaping therapy: Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses
Overall Study STARTED	59
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	22

Withdrawal data not reported

Corneal Biomechanics and Corneal Reshaping Therapy

Baseline characteristics by cohort
Measure	Corneal Reshaping Therapy n=37 Participants Participants receiving Corneal Reshaping Therapy were monitored for ocular biometry and refractive errors throughout a 6-month period. Corneal stiffness and tangent modulus were outcome measures.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	22 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Hong Kong	37 participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	Treatment n=37 Participants Treatment
Change of Corneal Stiffness From Baseline at 6 Months	0.061 N/mm Standard Deviation 0.007

Timeframe: 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.

Outcome measures
Measure	Treatment n=37 Participants Treatment
Change of Tangent Modulus From Baseline at 6 Months	0.536 MPa Standard Deviation 0.118

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

The Hong Kong Polytechnic University

Phone: 85227666109