The Different Design of Orthokeratology

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956704
• Other study ID #: KY2023031
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in axial length	Axial length was measured with a biometer	The change of baseline and 1years