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Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

NCT ID: NCT05433259

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-11-01

Brief Summary

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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

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Conditions

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Contact Lenses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CRT type lens

Subjects fitted with CRT type lenses

Group Type EXPERIMENTAL

Overnight orthokeratology

Intervention Type DEVICE

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

VST type lens

Subjects fitted with VST type lenses

Group Type EXPERIMENTAL

Overnight orthokeratology

Intervention Type DEVICE

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

Interventions

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Overnight orthokeratology

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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OK lens-Angio OCT

Identifier Type: -

Identifier Source: org_study_id