Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs

NCT ID: NCT06825585

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Group

Myopic children who need OK lens treatment

Group Type: EXPERIMENTAL

Orthokeratology with 5.0mm back optical zone diameter

Intervention Type: DEVICE

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.

Control group

Myopic children who need OK lens treatment

Group Type: ACTIVE_COMPARATOR

Orthokeratology with a 6.2 mm back optical zone diameter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiaoyan Yang

OTHER

Sponsor Role: lead

Responsible Party

Xiaoyan Yang

Tianjin Eye Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tianjin Eye Hospital

Role: PRINCIPAL_INVESTIGATOR

Tianjin Eye Hospital Opotometic Center

Locations

Tianjin Eye Hospital Opotometric Center

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

Different Orthk lens

Identifier Type: -

Identifier Source: org_study_id