Corneal inlay showing positive results in multicenter European study

ALICANTE, Spain — Preliminary data from a multicenter European clinical trial suggest that the AcuFocus ACI 7000 corneal inlay has potential to become a new, minimally invasive option for treating patients who have presbyopia, according to a surgeon speaking here.

To date, 70 patients have been implanted with the device as part of the study, and 23 have reached 12 months follow-up, said Günther Grabner, MD, at the Alicante Refractiva International meeting.

At 1 year, uncorrected near vision averaged J1, and both intermediate and distance vision averaged 20/20, Dr. Grabner said.

However, "some time is needed for adaptation, but vision at all distances improves steadily over time," he said.

Preoperatively, near vision averaged between J7 and J8 and improved to average J2 at 1 month and J1 at 9 months, Dr. Grabner said.

He noted that potential problems are mainly related to implant positioning, as the device must be well-centered. In his experience implanting the ACI 7000 corneal inlay in 45 patients, Dr. Grabner has had to re-center the implant in three cases, he said.

Jorge L. Alió, MD, PhD, also stressed the importance of good centration on the line of sight. In addition to restricting light penetration, which is characteristic of the implant, decentration can lead to optical aberrations, he said.

"We mark the line of sight on the cornea, with the aid of a special device, and this definitely helps centration," Dr. Grabner said.

In addition, the inlay does not seem to interfere with surgeons' abilities to perform ophthalmic examinations or surgical procedures at the corneal, anterior chamber, lens or retinal levels, he noted.

"If you need to perform macular surgery, you can easily remove the implant, carry out the procedure and put the implant back in place," Dr. Grabner said.