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First 12 months results of the Dutch cohort with the EndoArt artificial corneal endothelium implantation in a First in Human Safety Study.

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First Author: R.Lapid-Gortzak THE NETHERLANDS

Co Author(s):    I. van der Meulen   O. Daphna                 

Abstract Details

Purpose:

To report the preliminary results of the implantation of an artificial corneal endothelial device, the Endoart (EyeYon Medical, Israel). Currently the state-of-the-art treatment for corneal endothelial failure is the use of human donor tissue via tissue-banking and transplantation techniques. The Endoart device is an acrylic disc replacing the endothelial layer intended for use in patients with corneal endothelial failure, with the aim of providing corneal clarity, without the use of human donor tissue. The first in human study takes place in Europe (the Netherlands, Spain) and in Israel. We report on the Dutch patient group.

Setting:

Department of Ophthalmology, Amsterdam University Medical Centers, location AMC, Amsterdam, the Netherlands.

Methods:

In a prospective safety study until now 4 patients with corneal endothelial failure were included. All patients had a corneal indication for endothelial keratoplasty surgery, but with concurrent severe monocular comorbidity which possibly limits visual gain from endothelial keratoplasty, with good visual acuity in the fellow eye. Under general anesthesia the Endoart was implanted and positioned against the interior cornea after removal of the diseased endothelium. Position was checked with an anterior OCT. Patients were followed as per protocol. Study parameters were device attachment, shift, re-bubble rates, cornea thickness, and clarity, visual acuity, and adverse events.

Results:

Four eyes of 4 patients received the 6.3mm/50microns Endoart implant. Three of 4 patients were female, the mean age was 67.9 years + 11.4 (range 57-82). All Endoart devices remained attached after initial re-bubbling, one device was sutured. Corneal thickness decreased in 3 out of 4 eyes (1187 to 738 microns, 839 to 628 microns, and 864 to 601 microns), in 2 out of 4 eyes visual acuity improved from logMAR 2 to 0.82 (decimal 0.16) and logMAR 0.6 to 0.24 (decimal 0.63--). No device related adverse events occurred.

Conclusions:

In the first 4 patients the Endoart was safely attached throughout the study period 3-12 months. In most patients the cornea thickness decreases, without pathological thinning. Visual acuity improved in 2 patients, even though patient selection for the first in man study included only eyes with a guarded visual prognosis. Ongoing study is being done to improve the procedure and its outcomes.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation, ... travel has been funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company