NCT03616600

The Safety and Effectiveness of Breath-O Lenses

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia
• Safety Issues

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-08-31
• Completion: 2019-01-15
• First posted: 2018-08-06
• Last updated: 2021-02-10
• Results posted: 2020-04-13

Locations

1 site across 1 country: Hong Kong