Clinical trial NCT03616600: The Safety and Effectiveness of Breath-O Lenses
Official title: The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Safety Issues
Keywords: Myopia
Orthokeratology
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: SEED Co. Ltd.
First posted: 2018-08-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Best corrected Visual acuity: monocular ETDRS 0.0 or better
3. Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
4. General health: No systemic diseases
5. 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

Primary outcomes:
measure: Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
timeFrame: Baseline, 1st Month, 3rd Month
measure: Corneal Endothelial Health in Terms of Endothelial Cell Density
timeFrame: Baseline, 1st Month, 3rd Month
measure: Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
timeFrame: Baseline, 1st Month, 3rd Month
measure: Anterior Ocular Health in Terms of Limbal and Bulbar Redness
timeFrame: Baseline, 1st Month, 3rd Month
measure: Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
timeFrame: Baseline, 1st Month, 3rd Month
Secondary outcomes:
measure: Best Corrected Visual Acuity in Terms of High and Low Contrast
timeFrame: Baseline, 1st Month and the 3rd Month
measure: Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
timeFrame: Baseline, 1st Week, 1st Month, 3rd Month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: