Myopia and myopic astigmatism with a spherical power more than -4.00D up to -6.00D.
Conditions
Interventions
Subjects wear Orthokeratology lenses for a 1 year.
Sponsors
Nakamura Kikue
Eligibility
Inclusion criteria
Inclusion criteria: (1) Individuals aged 8 years or older at the time of informed consent, regardless of gender. (2) Individuals with a spherical power more than -4.00D up to -6.00D in subjective refraction test. (3) Individuals with astigmatism up to -2.00D in subjective refraction test ; however, for against-the-back astigmatism, up to -0.75D . (4) Individuals with a corneal curvature radius (corneal refractive power) from 39.00D to 47.00D. (5) Individuals who achieve a result of 5mm or more within 5 minutes in the Schirmer I test. (6) Individuals with a corneal endothelial cell density of 2,000 cells/mm^2 or more. (7) Individuals with the best corrected visual acuity of 1.0 or better using glasses. (8) Individuals who can attend scheduled clinic visits in accordance with the protocol. (9) Individuals who understand the content of the trial and provide written informed consent voluntarily; for minors, both the minor's consent and written consent from a legal representative (parent or guardian) are required. (10) In the case of a minor subject, the legal representative or family members must be able to assist the subject in handling and managing the lenses.
Exclusion criteria
Exclusion criteria: (1) Individuals with corneal and conjunctival findings, and eyelid findings (as per the slit-lamp microscope examination criteria with findings marked as * or higher). (2) Individuals with uveitis. (3) Individuals with unstable corneal refraction or irregular astigmatism. (4) Individuals with severe dry eye or lacrimal system disorders that interfere with lens wear. (5) Patients with allergic diseases that may affect lens wear. (6) Individuals with reduced corneal sensitivity. (7) Individuals with ocular or systemic diseases that may affect vision or refraction. (8) Individuals with serious heart, liver, kidney, lung, blood disorders, or other complications deemed unsuitable for the trial. (9) Individuals with immune disorders or diabetes. (10) Individuals with a history of anaphylaxis. (11) Pregnant or breastfeeding women, or individuals who plan to become pregnant between the informed consent and the end of the trial. (12) Individuals with a history of refractive surgery. (13) Individuals who have used hard contact lenses within the past month. (14) Individuals with experience using orthokeratology lenses. (15) Individuals who wear lenses for monocular vision, or wear lenses in only one eye. (16) Individuals who have participated in any clinical trials or research studies in any field within the past 3 months, or individuals who are scheduled to participate in any such trials during the course of this study. (17) Individuals who are deemed unsuitable for the trial by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity at 52 weeks | — |
Contacts
Public ContactKikue Nakamura
SEED Co., Ltd.
Outcome results
None listed