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First patient enrolled in enVista MX60EF trifocal IOL trial

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Bausch + Lomb has enrolled the first patient in a clinical trial of the enVista MX60EF trifocal IOL, according to a press release.

The multicenter, randomized study is evaluating the efficacy and safety of the lens. It will include more than 500 patients undergoing bilateral cataract surgery who are randomly assigned to receive the trifocal IOL or the enVista MX60E monofocal IOL, the release said.

The study of the single-piece, ultraviolet-absorbing posterior chamber IOL is intended to support a premarket approval application filing with the FDA. Based on postoperative observation, efficacy endpoints will be determined after 6 months and safety endpoints after 12 months.

“The initiation of this trial is an important milestone for our organization and another example of our commitment to investing in research and innovation,” Chuck Hess, vice president and general manager of U.S. Surgical at Bausch + Lomb, said in the release. “We look forward to providing surgeons with another next-generation posterior chamber intraocular lens designed to meet their rapidly evolving needs.”

No trifocal IOLs have been approved by the FDA.