Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs

NCT06825585 | Completed

• 1 other identifier: Different Orthk lens
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Myopia; Myopia; Refractive Error

Outcome Measures

Primary Outcomes (1)

• Changes in axial length

  Axial length was measured with a biometer

  The change of baseline and 1years

Other Outcomes (3)

• Change of visual quality

  Follow-up evaluations were conducted at baseline, and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after lens wear. The differences from baseline were calculated for each follow-up period.

• Change of wavefront aberrations

  Follow-up evaluations were conducted at baseline, and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after lens wear. The differences from baseline were calculated for each follow-up period.

• Change of contract sensitivity

  Follow-up evaluations were conducted at baseline, and at 1 week, 1 month, 3 months, and 12 months after lens wear. The differences from baseline were calculated for each follow-up period.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Myopic children who need OK lens treatment

Device: Orthokeratology with 5.0mm back optical zone diameter

Control group

ACTIVE COMPARATOR

Myopic children who need OK lens treatment

Device: Orthokeratology with a 6.2 mm back optical zone diameter

Interventions

Orthokeratology with 5.0mm back optical zone diameter 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.

Experimental Group

Orthokeratology with a 6.2 mm back optical zone diameter 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.

Control group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 8 and 13 years.
• Subjective refraction under cycloplegia: spherical power between -4.00 D and
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaoyan Yang: lead

Study Sites (1)

Tianjin Eye Hospital Opotometric Center

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Tianjin Eye Hospital

  Tianjin Eye Hospital Opotometic Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tianjin Eye Hospital

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: January 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (1)