NCT06825585

Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Xiaoyan Yang · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed 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.

Conditions

• Myopia
• Myopia; Refractive Error

Interventions

Type	Name	Description
DEVICE	Orthokeratology with 5.0mm back optical zone diameter	The orthokeratology lenses used in this study were Double Reservoir Lenses (DRL) manufactured by Precilens (Creteil, France). The lenses feature a dual reverse-curve design with a back optic zone diameter (BOZD) of 5.0 mm.
DEVICE	Orthokeratology with a 6.2 mm back optical zone diameter	The orthokeratology lenses used were Euclid lenses manufactured by Euclid Systems (Herndon, VA, USA). These lenses feature a four-zone, five-curve design with a back optic zone diameter (BOZD) of 6.2 mm.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-03-31
• Completion: 2022-05-31
• First posted: 2025-02-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: China