Evaluating different designs of Orthokeratology lenses for myopia control
Effects of Different Designs of Orthokeratology Lens on Myopia Control and Visual Quality
This study is testing different designs of special contact lenses to see which ones work best for controlling nearsightedness in people compared to regular glasses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | Tianjin Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05192824 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different designs of Orthokeratology lenses, specifically variations in the size of the central optical zone and the height of the peripheral reverse curve, affect myopia control and visual quality. Participants are divided into groups based on the optical zone size, ranging from 5.5 mm to 6 mm, with a control group using standard glasses. The effectiveness of the lenses is assessed by measuring axial length progression, while visual quality is evaluated through questionnaires, contrast sensitivity tests, and wavefront aberration analysis.
Who should consider this trial
Good fit: Ideal candidates are individuals with myopia between -1.00D and 4.00D in both eyes, with specific criteria for astigmatism and visual acuity.
Not a fit: Patients with contraindications for wearing Orthokeratology lenses, or those with conditions like strabismus or amblyopia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide improved methods for controlling myopia progression in children and adolescents.
How similar studies have performed: Other studies have shown promising results with Orthokeratology lenses for myopia control, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Myopia: between -1.00D and 4.00D in both eyes * Astigmatism: \<1.5D for with-the-rule astigmatism, \<1.00D for the against-the-rule astigmatism * Visual acuity: the best corrected vision acuity(BCVA)≥20/20 in both eyes * Subjects that volunteer to participate in the clinical trial and sign informed consent Exclusion Criteria: * Contraindications of wearing Ortho-K. * Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases. * Any type of strabismus or amblyopia * Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome) * Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
Where this trial is running
Tianjin, Tianjin
- Tianjin Eye Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Shuxian Zhang, MD
- Email: xindewo2006@163.com
- Phone: +8618630996574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.