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A team of seven leading ophthalmologists has been assembled to evaluate the accommodative properties of a proprietary material (Collamer, STAAR Surgical) used in the company's accommodating IOLs, it was announced in a prepared statement.
Monrovia, CA-A team of seven leading ophthalmologists has been assembled to evaluate the accommodative properties of a proprietary material (Collamer, STAAR Surgical) used in the company’s accommodating IOLs, it was announced in a prepared statement. CAST (Collamer Accommodating Study Team), the name of the team, was formed during the American Academy of Ophthalmology annual meeting.
A collaborative, phased approach will be used for the evaluation, according to the company:
Phase I will begin with the launch of the aspheric single-piece model of the lens. The initial goal is to collect baseline accommodative data on the performance of the lens-each member will collect near and distance visual acuity data from their patients who have received the accommodating IOL implant.
Phase II will evaluate the changes that have been made to the current model of the lens, which was engineered to maximize the level of accommodation, against the baseline data collected from phase I. This phase also will be an indicator of whether the company will apply for an accommodative labeling claim from the FDA, based on the collected data.
Phase III will involve a newly designed lens that would require a full clinical study and submission to the FDA for approval to commercialize the device and make accommodative claims in the United States.
"Our patented [lens] material is similar to the eye’s natural crystalline lens in its ability to refract light, its flexibility, and high water content-all characteristics necessary for high-quality visual outcomes," said Barry G. Caldwell, president and chief executive officer of STAAR Surgical.
The name of the material is derived from its composition of 100% pure collagen copolymer, according to the statement.