N/A
N=31
The Safety and Effectiveness of Breath-O Lenses
Myopia · Safety Issues
Bottom Line
View on ClinicalTrials.gov: NCT03616600 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor — 11.12; 11.10; 10.37; 11.20 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breath-O-Correct Lens (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Hong Kong Polytechnic University
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor |
11.12; 11.10; 10.37; 11.20; 10.14; 11.19 | — |
| PRIMARY Corneal Endothelial Health in Terms of Endothelial Cell Density |
2909; 2861; 2923; 2818; 2917; 2825 | — |
| PRIMARY Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size |
28.68; 29.35; 28.47; 29.00; 29.00; 30.01 | — |
| PRIMARY Anterior Ocular Health in Terms of Limbal and Bulbar Redness |
0.57; 0.58; 0.47; 0.52; 0.54; 0.61 | — |
| PRIMARY Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT) |
6.72; 9.92; 9.13; 9.17; 9.83; 7.64 | — |
| SECONDARY Best Corrected Visual Acuity in Terms of High and Low Contrast |
-0.10; -0.07; -0.08; 0.08; 0.22; 0.17 | — |
| SECONDARY Reduction of the Refractive Power After Wearing the Breath-O-correct Lens |
-3.52; -0.17; -0.11; -0.03 | — |
Summary
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.
Eligibility Criteria
Inclusion Criteria
- Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)
- Best corrected Visual acuity: monocular ETDRS 0.0 or better
- Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
- General health: No systemic diseases
- Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period
Data sourced from ClinicalTrials.gov (NCT03616600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.