Breakthrough in Ophthalmology: Celebrating Five Years of the EndoArt Artificial DMEK-Implantation

by Odelle Technology

In a significant milestone for ophthalmology, we are celebrating the fifth anniversary of the first successful implantation of the EndoArt artificial DMEK-implant in humans. On June 18, 2019, this groundbreaking procedure was performed at the Heidelberg University Eye Clinic, marking a new era in the treatment of chronic corneal oedema.

The Patient’s Journey

The patient, a 58-year-old female, had a complex medical history, including cataract surgery, subsequent endophthalmitis, posterior vitrectomy (ppVE), and corneal endothelial decompensation leading to optic atrophy. After a failed conventional DMEK, she was left with end-stage bullous keratopathy and severe pain. Her central corneal thickness (CCT) was 730 microns, and her visual acuity (VA) was reduced to hand motion (HM).

The Procedure and Immediate Outcomes

The EndoArt device, developed by EyeYon Medical, is a flexible, 50-micron thin artificial endothelial layer. It is designed to mimic the posterior curvature of the cornea and act as a fluid barrier, effectively replacing the diseased endothelium. The device is implanted into the anterior chamber and positioned on the posterior stroma, where it is secured with an air-gas mixture.

Immediately following the implantation, the patient’s cornea began to clear. Within a day, her CCT had decreased to 500 microns, and the pain had disappeared completely. This rapid improvement highlighted the potential of EndoArt as a viable alternative to traditional DMEK procedures.

Long-Term Success and Stability

Over the past five years, the patient’s condition has remained stable with no adverse effects on the implant. The cornea has maintained its clarity, and there have been no significant changes in CCT or VA. This long-term stability underscores the efficacy and safety of the EndoArt device for treating chronic corneal oedema.

Clinical Study and Publication

The success of this procedure is documented in a study published in the journal Cornea. The study, titled “Implantation of an Artificial Endothelial Layer for Treatment of Chronic Corneal Edema,” was co-authored by a team of experts including Gerd U. Auffarth, Hyeck-Soo Son, Matthias Koch, Jan Weindler, Patrick Merz, Ofer Daphna, Arie L. Marcovich, and Victor A. Augustin. The study details the methods and outcomes of the EndoArt implantation, providing valuable insights for future applications in ophthalmic surgery.

The study reported significant outcomes in two patients with chronic corneal edema:

– Patient 1: CCT decreased from 730 μm preoperatively to 593 μm one day postoperatively and stabilized at 526 μm at the 17-month follow-up.

– Patient 2: CCT reduced from 761 μm preoperatively to 487 μm one day postoperatively, stabilizing at 457 μm at the 17-month follow-up.

Both patients reported significant improvements in visual quality and satisfaction. Despite some occurrences of lamella dislocation, repositioning procedures restored and maintained CCT effectively. Unlike biological donor tissues, the artificial lamella proved to be robust, easily manipulated, and required no immunosuppressive treatment due to its nonbiological nature.

Acknowledgements and Collaborations

This achievement would not have been possible without the dedicated efforts of a talented team of researchers and clinicians. Special thanks go to Son HS, Koch M, Weindler J, Merz P, Daphna O, Marcovich AL, Augustin VA, and EyeYon Medical. Additionally, Ofer Daphna, Arin Marcovich, Nahum Ferera, and Richel Liu made invaluable contributions to this groundbreaking work.

Conclusion

The successful implantation of the EndoArt artificial DMEK implant represents a significant advancement in the treatment of chronic corneal edema. This innovative approach offers new hope for patients suffering from this debilitating condition, providing them with improved vision and quality of life. As we look to the future, the continued development and refinement of such technologies hold great promise for the field of ophthalmology.

For further details, you can access the full publication: Auffarth GU, Son HS, Koch M, Weindler J, Merz P, Daphna O, Marcovich AL, Augustin VA. “Implantation of an Artificial Endothelial Layer for Treatment of Chronic Corneal Edema.” Cornea. 2021 Dec 1;40(12):1633-1638. doi: 10.1097/ICO.0000000000002806. PMID: 34294634; PMCID: PMC8963521. (https://doi.org/10.1097/ICO.0000000000002806 .

References

1. Auffarth GU, Son HS, Koch M, Weindler J, Merz P, Daphna O, Marcovich AL, Augustin VA. “Implantation of an Artificial Endothelial Layer for Treatment of Chronic Corneal Edema.” Cornea. 2021 Dec 1;40(12):1633-1638. doi: 10.1097/ICO.0000000000002806. PMID: 34294634; PMCID: PMC8963521. https://doi.org/10.1097/ICO.0000000000002806 .

2. EyeYon Medical. “Implantation of an Artificial Endothelial Layer for Treatment of Chronic Corneal Edema.” https://eye-yon.com/publications/implantation-of-an-artificial-endothelial-layer-for-treatment-of-chronic-corneal-edema/ .

3. Ingenta Connect. “Implantation of an Artificial Endothelial Layer for Treatment of Chronic Corneal Edema.”https://www.ingentaconnect.com/content/wk/jcr/2021/00000040/00000012/art00013

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