The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Corneal Endothelial Health in Terms of Endothelial Cell Density
Study Overview
Brief 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.
Detailed Description
Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment
Wearing the orthokeratology lenses for 3 months
Intervention: Breath-O-Correct Lens (Other)
Control
Not wearing any contact lenses
Outcomes
Primary Outcomes
Corneal Endothelial Health in Terms of Endothelial Cell Density
Time Frame: Baseline, 1st Month, 3rd Month
measured by specular microscope
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Time Frame: Baseline, 1st Month, 3rd Month
measured by specular microscope
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Time Frame: Baseline, 1st Month, 3rd Month
measured by ocular response analyser
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
Time Frame: Baseline, 1st Month, 3rd Month
measured by OCULUS Keratograph® 5M
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Time Frame: Baseline, 1st Month, 3rd Month
measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests
Secondary Outcomes
- Best Corrected Visual Acuity in Terms of High and Low Contrast(Baseline, 1st Month and the 3rd Month)
- Reduction of the Refractive Power After Wearing the Breath-O-correct Lens(Baseline, 1st Week, 1st Month, 3rd Month)
Investigators
Henry HL Chan, PhD
Assocaite Professor
The Hong Kong Polytechnic University