NCT06037850CompletedNot Applicable
Clinical Trial of Orthokeratology Lens (MCOK-01)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Menicon Co., Ltd.
- Enrollment
- 390
- Locations
- 3
- Primary Endpoint
- Refraction
Study Overview
Brief Summary
A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
Detailed Description
The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •\ 1. Best corrected vision acuity of less than 0.8 with spectacles
- •2. Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D
- •3. 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)
- •4. 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.)
- •5. The medical history of refractive corneal surgery
- •6. Those in need of a strength out of the scope of lens for this clinical trial
- •7. Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
- •8. All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
- •9. Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding
- •10. Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days
- •11. Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
- •12. Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses)
- •13. Minor/adult subjects who lack mental capacity
- •14. Other not suitable for this clinical trial at investigator's discretion \ (1) Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion
Arms & Interventions
Treatment
Experimental
Randomized to Treatment
Intervention: Test orthokeratology lens (Device)
Control
Active Comparator
Randomized to Control
Intervention: Control orthokeratology lens (Device)
Outcomes
Primary Outcomes
Refraction
Time Frame: 1 year
spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
Axial length
Time Frame: 1 year
axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Visual acuity
Time Frame: 1 year
uncorrected visual acuity measured using logMAR chart
Secondary Outcomes
- Adverse Events(1 year)
Investigators
Study Sites (3)
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