Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

Sponsor

Wenzhou Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05433259

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lenses	Device: Overnight orthokeratology	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Influence on Biometric Factors Changes by Different OK Lens

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Mar 12, 2022

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT type lens Subjects fitted with CRT type lenses	Device: Overnight orthokeratology Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.
Experimental: VST type lens Subjects fitted with VST type lenses	Device: Overnight orthokeratology Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.

Arm

Intervention/Treatment

Experimental: CRT type lens

Subjects fitted with CRT type lenses

Device: Overnight orthokeratology

Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.

Experimental: VST type lens

Subjects fitted with VST type lenses

Device: Overnight orthokeratology

Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Axial length [up to 2 years]
Axial length growth after lens wear

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang	China

Sponsors and Collaborators

Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT05433259

Other Study ID Numbers:

OK lens-Angio OCT

First Posted:

Jun 27, 2022

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 30, 2022