The Safety and Effectiveness of Breath-O Lenses

Myopia Clinical Trial

Official title:

The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616600
• Other study ID #: HongKongPU_Optometry2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: January 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 15, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Safety Issues

Intervention

Other:
• Breath-O-Correct Lens
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

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	SEED Co. Ltd.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor	measured by ocular response analyser	Baseline, 1st Month, 3rd Month
Primary	Corneal Endothelial Health in Terms of Endothelial Cell Density	measured by specular microscope	Baseline, 1st Month, 3rd Month
Primary	Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size	measured by specular microscope	Baseline, 1st Month, 3rd Month
Primary	Anterior Ocular Health in Terms of Limbal and Bulbar Redness	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	Baseline, 1st Month, 3rd Month
Primary	Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)	measured by OCULUS Keratograph® 5M	Baseline, 1st Month, 3rd Month
Secondary	Best Corrected Visual Acuity in Terms of High and Low Contrast	The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)	Baseline, 1st Month and the 3rd Month
Secondary	Reduction of the Refractive Power After Wearing the Breath-O-correct Lens	Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)	Baseline, 1st Week, 1st Month, 3rd Month