NCT05433259

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 21, 2022

Last Update Submit

June 25, 2022

Conditions

Contact Lenses

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Axial length

    up to 2 years

Study Arms (2)

CRT type lens

EXPERIMENTAL

Subjects fitted with CRT type lenses

Device: Overnight orthokeratology

VST type lens

EXPERIMENTAL

Subjects fitted with VST type lenses

Device: Overnight orthokeratology

Interventions

Overnight orthokeratologyDEVICE

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

CRT type lensVST type lens

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who had previously worn contact lens, were also excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

September 1, 2021

Primary Completion

March 12, 2022

Study Completion

November 1, 2023

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

CN(1)