MedPath

Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

Not Applicable
Conditions
Contact Lenses
Interventions
Device: Overnight orthokeratology
Registration Number
NCT05433259
Lead Sponsor
Wenzhou Medical University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CRT type lensOvernight orthokeratologySubjects fitted with CRT type lenses
VST type lensOvernight orthokeratologySubjects fitted with VST type lenses
Primary Outcome Measures
NameTimeMethod
change of Corneal Epitheliumup to 1 day, 1 week,1 month

All epithelial thickness and treatment zone area record by baseline and follow up examination.

Secondary Outcome Measures
NameTimeMethod
Axial lengthup to 2 years

Axial length growth after lens wear

Trial Locations

Locations (1)

Eye Hospital of Wenzhou Medical College

🇨🇳

Wenzhou, Zhejiang, China

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