Bausch + Lomb Enrolls First Patient in Trial for enVista MX60EF Trifocal IOL

June 8, 2018: By Jon Swedien

Bausch + Lomb has enrolled the first patient in a clinical trial studying the efficacy and safety of the enVista MX60EF trifocal IOL, the company announced June 4.

The lens is a single-piece, ultraviolet-absorbing posterior chamber IOL.

The multicenter, randomized clinical study will include more than 500 subjects undergoing bilateral cataract surgery. Subjects will receive either the MX60EF trifocal or enVista MX60E monofocal IOL.  Investigators will determine efficacy endpoints after six months and safety endpoints after 12 months based on postsurgical observation.

Like the monofocal lens, the trifocal IOL will feature StableFlex technology for rapid optic recovery following delivery, the company said.

The trifocal IOL will also feature AccuSet haptics, which provide an offset design and broad contact angle, as well as the SureEdge design, which offers a continuous 360-degree square edge design, Bausch + Lomb said.

Currently, there are no FDA-approved trifocal IOLs available in the US.

Alcon’s AcrySof IQ PanOptix is expected to gain FDA approval in 2018, and it is the first US-developed trifocal IOL available in Europe, having received CE marking in January 2017.

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