A clinical trial of Orthokeratology lenses (development code: L001) for myopia and myopic astigmatism of spherical diopter power more than -4.00D up to -6.00D

JRCT ID: jRCT2032230435

Registered date:05/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myopia and myopic astigmatism (spherical diopter power more than -4.00D up to -6.00D)
• Date of first enrollment: 14/10/2023
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Subjects wear the investigational device for 12 months.

Outcome(s)

• Primary Outcome: Unaided vision at the last scheduled medical examination

Key inclusion & exclusion criteria

• Age minimum: >= 8age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Age at the time of consent acquisition: 8 years or older
(2) Persons who understand the outline of the clinical trial and signed the consent form. In the case of minors, consent of both the subject and his/her guardian is required.
(3) Spherical diopter power of the subject eye is within the applicable range (-4.00D to -6.00D). However, -4.00D is not included. The applicable range of cylindrical degree is 0 to -1.50D (for against-the-rule astigmatism (70 to 110), the applicable range of cylindrical power is 0 to -0.75D). )
(4) Best-corrected visual acuity of the subject eye: 1.0 or better
(5) The corneal refractive power (weak principal meridian value) of the subject eye: 40.00D to 46.25D
(6) The tear volume of subject eye which measured by the Schirmer I method, in 5 minutes, the wet length of the test paper is 5 mm or more.
(7) The endothelial cell density of the cornea of the subject eye is 2,000 cells/mm2 or more.
(8) Persons who can have the scheduled medical examinations and follow the procedures without fail.
(9) Persons who can use the investigational device appropriately and to keep the necessary hygiene management for wearing the investigational device. In the case of minors, the guardian should be able to support the subject.
(10) Persons who have been wearing hard contact lenses should stop wearing for at least two weeks, and persons who have been wearing soft contact lenses should stop wearing for at least one week, before having the applicable examination. During the withdrawal period wearing eyeglasses is permitted.

Exclude criteria

(1) Patients with acute or subacute inflammation of the anterior eye segment
(2) Patients with ocular infections
(3) Patients with uveitis
(4) Patients with reduced corneal sensitivity.
(5) Patients with corneal epithelial defects
(6) Patients with eyelid abnormalities. However, if the investigator judged that the abnormality is not significant, the patient is permitted to participate in the clinical trial.
(7) Patients with severe lacrimation decreased (dry eye) or lacrimal apparatus disease
(8) Patients who have had an allergic reaction to the eye surface or eye accessory, or have had an exacerbation of such reaction, due to wearing contact lenses or using care products for contact lenses.
(9) Patients with systemic diseases affecting the eye or systemic diseases aggravated by orthokeratology lens wear.
(10) Patients with immune disorders (e.g., acquired immune deficiency syndrome, autoimmune disease) or diabetes mellitus
(11) Patients with eye diseases, injuries, or malformations that affect the cornea, conjunctiva, or eyelids
(12) Persons who have continuous or frequent hyperemia or foreign-body sensation in the eyes.
(13) Patients with edema, staining, opacity, or neovascularization when the cornea is observed with a slit lamp. However, if the investigator judged that abnormality is not significant, the patient is permitted to participate in the clinical trial.
(14) Persons who have unstable corneal refractive power (curvature radius) measurement values or severe irregular astigmatism, or signs of keratoconus.
(15) Persons who have undergone laser corneal refractive surgery or intraocular lens insertion surgery
(16) Patients who are taking or planning to take drugs that may cause dry eye or affect vision (e.g., anti-inflammatory corticosteroids, mydriatics/cycloplegics for treatment purposes)
(17) Women who are pregnant, breastfeeding or planning to become pregnant during the study period
(18) Persons whose occupation always requires appropriate vision and have difficulty in taking a break from work when their vision is impaired
(19) Persons who are undergoing orthokeratology treatment in subject eye.
(20) Persons who are participating in other clinical trials. Those who participated in a contact lens clinical trial within 30 days before the applicable examination. Persons who participated in other clinical trials within 90 days before the applicable examination
(21) Others, persons who are considered inappropriate by the investigator.

Related Information

• Primary Sponsor: Ikai Kenzo