Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

Contact Lenses Clinical Trial

Official title:

The Influence on Biometric Factors Changes by Different OK Lens

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05433259
• Other study ID #: OK lens-Angio OCT
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: June 2022
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 1, 2023
• Est. primary completion date: March 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contact Lenses

Intervention

Device:
• Overnight orthokeratology
Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Corneal Epithelium	All epithelial thickness and treatment zone area record by baseline and follow up examination.	up to 1 day, 1 week,1 month
Secondary	Axial length	Axial length growth after lens wear	up to 2 years