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‘Refractive add’ inlay improves ability to read newsprint in presbyopes
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AMSTERDAM — A new corneal inlay procedure that is “reasonably successful,” but which is reversible and well tolerated, is available under CE mark, according to a presenter here.
The Icolens (Neoptics) is a “refractive add” type of inlay, Caroline Baily, MD, said at the European Society of Cataract and Refractive Surgeons meeting. It is a 3-mm hydrogel lens with an edge thickness of 15 microns or less and a central hole of 150 µm to facilitate nutrient flow. The Icolens System comprises the micro-lens, femtosecond pocket-cutting algorithm and a unique preloaded deployment device.
Giving 12-month data, Baily said that 52 inlays were implanted in the nondominant eye of 52 presbyopic emmetropic patients. Of these, 11 were explanted.
“All of these explantations were due to poor refractive outcomes as opposed to any corneal complications,” Baily said. “After removal, all patients were returned to their refractive baseline.”
Patients had a mean baseline corneal thickness of 563 µm and mean cutting depth was 295 µm. The only adverse event was mild glare that did not affect driving, Baily said. Of patients who retained their implants at 12 months, 91% were satisfied with the procedure in general and 95% did not feel their distance vision was impaired.
“This is a technical procedure with a significant learning curve,” Baily said. “To improve this, we’ve improved the insertion device. However, we feel we need to improve centration. … Most importantly, 10% did not work. We do not know why this is. It could be centration. We feel most likely it could be related to neuroadaptation.”
Since completion of the 12-month trial, Baily and colleagues have carried out 12 commercial procedures with, as yet, no explants or exchanges. At 1 month, 92% were reading at N8 or better – t hat is, able to read newsprint – but for uncorrected distance visual acuity, patients lost a mean of 1.7 lines, she said.
Disclosure: Baily has no relevant financial disclosures.