CLINICAL OUTCOME

  • Post Marketing Surveillance in Japan

In relation to the registered cases of 159 eyes, the cases of 153 eyes were subject to safety evaluations and the cases of 86 eyes were subject to effectiveness evaluations.

  • Safety

With the cases of 153 eyes subject to safety evaluations, adverse events were expressed with 9 of the eyes. Among these, there were 4 eyes where a causal relationship with the product concerned could not be denied but all were known and recovery has been confirmed with each case. In addition, dirt on the lens was an issue related to maintenance and management and this was resolved by requesting the ophthalmologist to provide guidance on proper use.

  • Validity

With the cases of 153 eyes subject to safety evaluations, adverse events were expressed with 9 of the eyes. Among these, there were 4 eyes where a causal relationship with the product concerned could not be denied but all were known and recovery has been confirmed with each case. In addition, dirt on the lens was an issue related to maintenance and management and this was resolved by requesting the ophthalmologist to provide guidance on proper use.

  • The Hong Kong Polytechnic University - Clinical Outcome

Effectiveness of Myopia Control by Breath-O Correct Lenses

This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O Correct Ortho-K lenses in different myopia progression groups classified according to their initial electro-retinal responses.

Sources : U.S National Library of Medicine - ClinicalTrials.gov

The Safety and Effectiveness of Breath-O Correct Lenses

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 Ortho-K lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

Sources : U.S National Library of Medicine - ClinicalTrials.gov

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