CE Mark approval obtained


STAAR Surgical has announced that its Visian Implantable Collamer Lens (ICL) V4c design has obtained CE Mark approval.

STAAR Surgical has announced that its Visian Implantable Collamer Lens (ICL) V4c design has obtained CE Mark approval.

The lens design incorporates a proprietary port in the centre of the ICL optic of a specific size that the company reports optimizes fluid flow within the eye and can eliminate the need for a surgeon to perform a YAG peripheral iridotomy procedure before implantation.

Clinical research on this technology has been performed by Dr Kimiya Shimizu, professor and chair of the Department of Ophthalmology at the Kitasato University in Tokyo, Japan. He started performing first phase trials in 2008 when he implanted six patients with the current ICL in one eye and the new V4c design in the fellow eye. Dr Shimizu performed iridotomies in the eyes implanted with the current ICL and not in the eyes with the new V4c design lens.

He continued his research performing the second phase study in 2010 using the same clinical protocol as before. He found that the post-op IOP of the fellow eyes was the same as the eyes with the current ICL model. Additionally, he evaluated other parameters such as visual acuity, contrast sensitivity, stability of refraction and visual disturbances and found similar results with the new design as have been achieved with the current model.

The V4c model has been approved in the -0.5 to -18.0 D myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.

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