Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

The Influence on Biometric Factors Changes by Different OK Lens

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Contact Lenses
• Intervention / Treatment: Device: Overnight orthokeratology

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Eye Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Axial length growth after lens wear	up to 2 years

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): March 12, 2022
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (ACTUAL): June 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: OK lens-Angio OCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No