Allograft Corneal Inlays For Presbyopia: 6 Months Clinical Results Of The Eu Multicenter Study

Published 2022 - 40th Congress of the ESCRS

Reference: FPM07.04 | Type: Free paper | DOI: 10.82333/stgw-2m27

Authors: Arthur Bernard Cummings* ¹ , Sheraz Daya ² , Pavel Stodulka ³ , Samer Hamada ⁴ , Aylin Kilic ⁵

¹Cataract and Refractive,Wellington Eye Clinic,Dublin,Ireland, ²Cataract and Refractive,Centre for Sight,London,United Kingdom, ³Cataract &amp; Refractive,Gemini Eye Clinics,Prague,Czech Republic, ⁴Cataract &amp; Refractive,Queen Victoria Hospital,East Grinstead,United Kingdom, ⁵Cataract and Refractive,Medipol University,Istanbul,Türkiye

Purpose

A prospective multicenter clinical study to evaluate the safety and effectiveness of intrastromal implantation of the Transform Corneal Allograft (TCA, Allotex, Boston, USA) for providing near vision in presbyopia subjects.

Setting

Wellington Eye Clinic, Dublin, Ireland

Medipol University, Istanbul, Turkey

Center For Sight, East Grinstead, UK

Queen Victoria Hospital, East Grinstead, UK

Gemini Eye Clinic, Praha, Czech Republic

Methods

Prospective, single-armed, non-masked, non-randomized, multicenter, interventional, clinical trial. 101 eyes of consecutive subjects were enrolled and implanted with the TCA. Informed consent was obtained. Subjects were presbyopic adults, needing from +1.75 D to +3.50 D reading add and uncorrected near visual acuity worse than 20/40 at 40 cm. Distance visual acuity correctable to 20/20 in both eyes. Efficacy analyzed by the increase in uncorrected near visual acuity. Safety analyzed by the preservation of best spectacle corrected visual acuity. Implantation performed under a standard Femtosecond laser flap (110 – 120 microns). Bilateral treatments were not permitted.

Results

Improvement in UCNVA (at 40 cm) at 6 months postoperatively in the treated eye to: monocular UCNVA 20/40 or better in 92/94 of eyes (97.9%) and monocular UCNVA 20/25 or better in 75/94 of eyes (79.8%) compared to preoperative numbers of eyes: 0/94 of eyes (0.0%). Safety: 4/94 eyes (4.3%) had BCDVA loss of 2 or more lines, 5/94 eyes (5.3%) had BCNVA loss of 2 or more lines, and eyes with preoperative BCDVA and BCNVA of 20/20 or better with a BCDVA and BCNVA worse than 20/40: 0/94 eye (0%). Diffuse lamellar keratitis (DLK) in two eyes. Flap lift and irrigation due to visual disturbances in one eye. TCA explanted due to visual dissatisfaction (N=3). After explantation, two eyes returned to baseline; one eye no additional follow-up.

Conclusions

At the 6 months end point of the study all effectiveness endpoints were achieved. The safety profile of the use of Allograft Corneal Lenticle for Presbyopia were found to be comparable to the adverse events know from femto-second laser LASIK or SMILE procedures.