The Different Design of Orthokeratology

NCT ID: NCT05956704

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-06-01

Brief Summary

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Group

Group Type: EXPERIMENTAL

Orthokeratology with aspheric wide inversion zone design in the optical zone

Intervention Type: DEVICE

An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone

Control group

Group Type: ACTIVE_COMPARATOR

Orthokeratology with traditional spherical design in the optical zone

Intervention Type: DEVICE

Subjects wore the orthokeratology with traditional spherical design in the optical zone

Blank control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Orthokeratology with aspheric wide inversion zone design in the optical zone

An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone

Intervention Type: DEVICE

Orthokeratology with traditional spherical design in the optical zone

Subjects wore the orthokeratology with traditional spherical design in the optical zone

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Eye Hospital

Tianjin, , China

Countries

China

Other Identifiers

KY2023031

Identifier Type: -

Identifier Source: org_study_id