The Different Design of Orthokeratology

The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Orthokeratology with aspheric wide inversion zone design in the optical zone; Device: Orthokeratology with traditional spherical design in the optical zone

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300020
    • Tianjin Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Device: 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
Active Comparator: Control group	Device: Orthokeratology with traditional spherical design in the optical zone; Subjects wore the orthokeratology with traditional spherical design in the optical zone
No Intervention: Blank control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in axial length	Axial length was measured with a biometer	The change of baseline and 1years

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: KY2023031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No