Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs

Xiaoyan Yang

Status

Completed

Conditions

Myopia; Refractive Error

Myopia

Treatments

Device: Orthokeratology with a 6.2 mm back optical zone diameter

Device: Orthokeratology with 5.0mm back optical zone diameter

Study type

Interventional

Funder types

Other

Identifiers

NCT06825585

Different Orthk lens

Details and patient eligibility

About

Orthokeratology (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. More recently, it is reported that the children wearing orthok lens of smaller back optical zone diameter (BOZD) demonstrated a smaller axial elongation when compared to children wearing lens with larger BOZD. We aimed to explored the myopia efficacy and visual quality of ortho-k with different BOZD (5.0mm or 6.2mm).

Full description

This prospective study aimed to evaluate the efficacy of orthokeratology lenses with different back optical zone diameters (BOZD) in slowing axial elongation. Additionally, visual quality will be assessed through measurements of wavefront aberrations, contrast sensitivity, and subjective visual quality using a validated questionnaire. The study seeks to explore the effectiveness of various Ortho-K lens designs and the potential factors influencing their outcomes.

Enrollment

60 patients

Sex

All

Ages

8 to 13 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age between 8 and 13 years.
Subjective refraction under cycloplegia: spherical power between -4.00 D and
1.00 D, with cylindrical power≤ 1.50 D.
Best-corrected visual acuity (BCVA) of ≥ 1.0 based on subjective refraction.
Willing to participate in the clinical trial and provide signed informed consent.

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