San Francisco-Early results from the FDA clinical trial of the Akreos Adapt IOL (Bausch & Lomb) show that the hydrophilic acrylic implant is meeting or exceeding FDA grid requirements for pseudophakic IOL performance, reported investigators at the annual meeting of the American Society of Cataract and Refractive Surgery.
"So far, patients are experiencing excellent uncorrected (UCVA) and best-corrected (BCVA) visual acuity outcomes and there have been no significant device-related adverse events," said Louis D. "Skip" Nichamin, MD, who is medical monitor for the study and enrolling patients at the Laurel Eye Clinic, Brookville, PA, where he is the director. "However, what strikes me more than anything else is the remarkable ability of this implant to center itself with-in the capsular bag. That feature is ostensibly due to its haptic design."
"Dr. Rupert Menapace, of Vienna, Austria, and colleagues have demonstrated that capsular bag diameter varies between individuals and correlates negatively with corneal power and positively with axial length," Dr. Nichamin explained. "The three different sizes of this IOL recognize that a single-diameter IOL is not ideal for all patients."
The FDA trial is under way at 14 clinical centers. It is an open-label study enrolling patients with cataracts and no other ocular pathology who are undergoing unilateral, in-the-bag implantation. The study will enroll up to 423 subjects, of whom 390 have been entered so far.
Dr. Silverstein reported outcomes for the first 50 subjects who reached the "Form 4" visit that takes place at 120 to 180 days postoperatively. The BCVA results, which are being evaluated as the primary efficacy outcome measure, showed 96.2% of eyes achieved a BCVA of 20/40 or better.
"According to the FDA grid for investigational IOL performance, the control rate for BCVA of 20/40 or better is 92.5%; the minimum threshold that must be achieved is 88.2%," Dr. Silverstein said. "We are delighted to see that the Akreos Adapt is outperforming both of those criteria."