The Different Design of Orthokeratology

Tianjin Eye Hospital

Status

Completed

Conditions

Myopia

Treatments

Device: Orthokeratology with traditional spherical design in the optical zone

Device: Orthokeratology with aspheric wide inversion zone design in the optical zone

Study type

Interventional

Funder types

Other

Identifiers

NCT05956704

KY2023031

Details and patient eligibility

About

In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.

Enrollment

90 patients

Sex

All

Ages

8 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The age is greater than 8 years and less than 18 years
The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
Be able to complete 12 months of follow-up
They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians

Exclusion criteria

One eye met the inclusion criteria
Patients with systemic diseases causing immunocompromised or affecting orthokeratology
There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
Abnormal cornea
Previous corneal surgery or corneal trauma history
Active keratitis (e.g., corneal infection)
Patients with best corrected distance visual acuity of less than 5.0
Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
Patients with refractive instability
Patients with overt strabismus
The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
Patients with dry eye are not suitable for orthokeratology
Patients with corneal endothelial cell density less than 2000 cells /mm2
Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days