Clinical trial NCT06825585: Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs
Official title: Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Myopia; Refractive Error
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Changes in axial length
timeFrame: The change of baseline and 1years
Secondary outcomes:
Other outcomes:
measure: Change of visual quality
timeFrame: 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.
measure: Change of wavefront aberrations
timeFrame: 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.
measure: Change of contract sensitivity
timeFrame: 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.
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital Opotometric Center
state: Tianjin
Study officials:
affiliation: Tianjin Eye Hospital Opotometic Center
name: Tianjin Eye Hospital
role: PRINCIPAL_INVESTIGATOR
References: