Early results of an ongoing clinical trial indicate implantation of a sterile allograft corneal inlay (Transform, Allotex) in the non-dominant eye is a promising option for presbyopia correction in emmetropic patients.

At the ASCRS-ASOA annual meeting in San Diego in May, Associate Professor of ophthalmology Aylin Kiliç, from Medipol University in Turkey, presented data from the first 10 patients enrolled in a prospective trial investigating the lenticule. The lenticule has a refractive add power of +2.5 D and is designed to improve near vision by increasing depth of focus and corneal power..

Data collected at three months supported the safety, biocompatibility, and effectiveness of the inlay. All patients achieved near uncorrected visual acuity (UCVA) better than 20/40, and although seven of the 10 implanted eyes lost one line of distance UCVA as a result of a slight myopic refractive shift, all patients maintained 20/20 binocular distance UCVA. The same good outcomes have been seen during follow-up textending to one year, said A/Prof Kiliç.

The Transform lenticule is created by using a custom excimer laser system to precisely shape lenticules made from donor corneal tissue procured and processed under Eye Bank Association of America (EBAA) standards, said manufacturer Allotex. The human corneal tissue can be added intrastromally under a flap or as an onlay, on top of Bowman’s membrane but under the epithelium, in a procedure taking less than 15 minutes. The lenticules undergo a process making them stabile with up to two years of shelf life and are packaged in a convenient manner for the surgeons use.

“The sterile allograft inlay surgery is a minimally invasive, short procedure involving no tissue removal, it is easy reversible and easy to exchange, and compared with a multifocal IOL, the inlay causes less optical side effects,” said A/Prof Kiliç.

No cases of clinically relevant haze or corneal opacities during the available follow-up of up to one year had been reported, she told the meeting.