Contact Lenses
Conditions
Brief summary
Subjects fit with VST or CRT type lens are reviewed 1 day to 2 year after first wearing the lens. Ocular examinations were performed, including slit-lamp biomicroscope, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), corneal topography (Medmont E300W, Medmont Pty Ltd, Melbourne, Australia), corneal refractive power (autorefractometer, KR880, Topcon, JAPAN), corneal epithelial thickness (Optical Coherence Tomography, RTVue-XR), axial length using IOL-Master 700 (Carl Zeiss Meditec AG). To investigate corneal and retina changes caused by overnight OK lens.
Interventions
DEVICEOvernight orthokeratology
Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Normal subjects without any history of ocular surgeries or diseases (except for refractive errors) or systemic diseases that might affect contact lens wearing. The spherical error between -1.0 and -5.0 D, cylindrical error of at most 2.0 D, and a corrected distance visual acuity of 20/20 or better.
Exclusion criteria
* Subjects who had previously worn contact lens, were also excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Corneal Epithelium | up to 1 day, 1 week,1 month | All epithelial thickness and treatment zone area record by baseline and follow up examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | up to 2 years | Axial length growth after lens wear |
Countries
China
Outcome results
None listed