The First In Human Three Cases Of The Corneat Keratoprosthesis Implantation
Published 2022
- 40th Congress of the ESCRS
Reference: FPT06.05
| Type: Free paper
| DOI:
10.82333/qmpb-6p95
Authors:
Irit Bahar 1
, Olga Reitblat 2
, Gilad Litvin* 3
, Eitan Livny 2
1Ophthalmology,Rabin Medical Center,Petah Tikva,Israel;Tel Aviv University Sackler Faculty of Medicine,Tel Aviv,Israel, 2Ophthalmology,Rabin Medical Center,Petah Tikva,Israel, 3CorNeat Vision Ltd,Raanana,Israel
Purpose
To describe the first-in-human three implantations of the CorNeat keratoprosthesis, a novel synthetic corneal implant, which utilizes a polymeric scaffold for bio-integration, consequently assimilating synthetic optics within ocular tissue.
Setting
Ophthalmology Department, Rabin Medical Center, Petach Tikva, Israel.
Methods
Three bi-laterally blind Caucasian male patients between the ages of 61-78 years underwent a unilateral implantation of the CorNeat keratoprosthesis. All three subjects had visual acuity of HM in the operated eye, the first two due to multiple failed grafts and the third due to Ocular Cicatricial Pemphigoid. Each surgery was conducted using a designated technique, that will be detailed during the presentation.
Results
Follow up period range was 9-12 months. Intraoperative bleeding appeared in 1 case. Difficulty in positioning the keratoprosthesis appeared in 2/3 cases, of them one required replacement of the keratoprosthesis due to postoperative hypotony. Postoperative conjunctival retraction appeared in all cases. One case developed epithelial and fibrovascular tissue downgrowth. In 2 cases the keratoprosthesis was explanted due to suspected infection, with subsequent positive cultures for mixed bacterial species and Candida albicans. Final BCVA was 6/90, HM and LP.
Conclusions
The CoreNeat keratoprosthesis offers an alternative to current keratoprosthesis procedures, with potential advantages including subconjunctival integration, wide visual field and favorable cosmetic results. However, intraoperative difficulties and postoperative complications such as conjunctival retraction, infection, and tissue downgrowth need to be addressed. Our initial experience in this first in human trial is integrated into a learning curve of additional implantations taking place worldwide with amendments to the surgical technique, post op care and patient selection. Longer follow-up and additional implantations are desired to prove the long-term safety and efficacy of this device.