Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in axial length
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 8 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Experimental Group
Myopic children who need OK lens treatment
Intervention: Orthokeratology with 5.0mm back optical zone diameter (Device)
Control group
Myopic children who need OK lens treatment
Intervention: Orthokeratology with a 6.2 mm back optical zone diameter (Device)
Outcomes
Primary Outcomes
Changes in axial length
Time Frame: The change of baseline and 1years
Axial length was measured with a biometer
Secondary Outcomes
No secondary outcomes reported
Investigators
Xiaoyan Yang
Tianjin Eye Hospital
Tianjin Eye Hospital