The Different Design of Orthokeratology

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Orthokeratology with traditional spherical design in the optical zone; Device: Orthokeratology with aspheric wide inversion zone design in the optical zone

• Registration Number: NCT05956704
• Lead Sponsor: Tianjin Eye Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Orthokeratology with traditional spherical design in the optical zone	-
Experimental Group	Orthokeratology with aspheric wide inversion zone design in the optical zone	-

Primary Outcome Measures

Name	Time	Method
Changes in axial length	The change of baseline and 1years	Axial length was measured with a biometer

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China