Clinical Trial of Orthokeratology Lens (MCOK-01)
Test orthokeratology lens
+ Control orthokeratology lens
Eye Diseases
+ Myopia
+ Refractive Errors
Treatment Study
Summary
Study start date: July 29, 2022
Actual date on which the first participant was enrolled.This study focuses on testing a new type of contact lens called the orthokeratology lens, which is designed to improve vision by temporarily reshaping the cornea. The study compares this new lens to another orthokeratology lens that is already available on the market. It aims to enroll 390 participants and observe them over a period of 12 months. The goal is to assess how well the new lens performs in comparison to the existing option, which could lead to better vision correction solutions for those needing such lenses. Participants in this study will use the orthokeratology lenses as part of their daily routine. The study does not specify the exact method of lens application, but typically such lenses are worn overnight to reshape the cornea while sleeping. During the 12-month observation period, researchers will closely monitor the effectiveness and safety of the lenses by examining various vision-related outcomes. Although specific risks and benefits are not detailed, the study aims to ensure that the new lenses are at least as effective and safe as the existing ones.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.390 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patients with myopia and myopic astigmatism 2. Those who are not willing to wear glasses in daily life 3. 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 4. Those who can visit the institution on scheduled dates 5. Those who can receive guidance and tests as required by the investigator 6. Those who fully understand and follow the instructions of the lenses for this clinical trial Exclusion Criteria: \<At screening\> 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 \<At the beginning of the wearing\> (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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Myopia Specialist Centre
Singapore, SingaporeStan Isaacs
Singapore, Singapore