NCT06037850

Brief Summary

A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

July 29, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

August 23, 2023

Last Update Submit

February 5, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

  • Visual acuity

    uncorrected visual acuity measured using logMAR chart

    1 year

  • Axial length

    axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)

    1 year

  • Refraction

    spherical and cylinder power in diopter for best corrected visual acuity measured subjectively

    1 year

Secondary Outcomes (1)

  • Adverse Events

    1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Randomized to Treatment

Device: Test orthokeratology lens

Control

ACTIVE COMPARATOR

Randomized to Control

Device: Control orthokeratology lens

Interventions

Test orthokeratology lensDEVICE

Randomized to test orthokeratology lens worn during sleep every night

Treatment
Control orthokeratology lensDEVICE

Randomized to control orthokeratology lens worn during sleep every night

Control

Eligibility Criteria

Age6 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with myopia and myopic astigmatism
  • Those who are not willing to wear glasses in daily life
  • Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness
  • Those who can visit the institution on scheduled dates
  • Those who can receive guidance and tests as required by the investigator
  • Those who fully understand and follow the instructions of the lenses for this clinical trial

You may not qualify if:

  • \<At screening\>
  • Best corrected vision acuity of less than 0.8 with spectacles
  • Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D
  • Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
  • The medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc.)
  • The medical history of refractive corneal surgery
  • Those in need of a strength out of the scope of lens for this clinical trial
  • Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
  • All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
  • Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding
  • Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days
  • Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
  • Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses)
  • Minor/adult subjects who lack mental capacity
  • Other not suitable for this clinical trial at investigator's discretion \<At the beginning of the wearing\>
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

I&VISION Research Centre

Singapore, 248649, Singapore

Location

Myopia Specialist Centre

Singapore, 248649, Singapore

Location

Stan Isaacs

Singapore, 248649, Singapore

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Stan Isaacs

    I & Vision Research Centre Pte. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 14, 2023

Study Start

July 29, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

SG(3)