The Different Design of Orthokeratology

NCT05956704 | Completed DMC

• 1 other identifier: KY2023031
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in axial length

  Axial length was measured with a biometer

  The change of baseline and 1years

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Device: Orthokeratology with traditional spherical design in the optical zone

Blank control group

NO INTERVENTION

Interventions

Orthokeratology with aspheric wide inversion zone design in the optical zone DEVICE

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

Experimental Group

Orthokeratology with traditional spherical design in the optical zone DEVICE

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

Control group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: December 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)