The first-in-human implantation of the CorNeat keratoprosthesis.

OBJECTIVES: To describe the first clinical implantation of the CorNeat™ keratoprosthesis, which utilizes a polymeric scaffold for biointegration within ocular tissue. METHODS: The CorNeat keratoprosthesis was implanted in the right eye of a patient with bilateral corneal opacification and neovascularization secondary to multiple failed grafts. The following surgical technique was used: 360 degree peritomy; epithelial scraping and corneal marking; pre-placement of three corneo-scleral sutures through the implant; central trephination using a 7 mm trephine and host cornea removal; keratoprosthesis placement and sutures tightening while fitting the corneal edge into the posterior groove of the CorNeat keratoprosthesis; and repositioning of the conjunctiva over the implant skirt and fixation with sutures and Fibrin sealant. RESULTS: Twelve months postoperatively visual acuity improved to 1/16 from hand movement. The keratoprosthesis was properly positioned. Tactile intraocular pressure was assessed as normal. Regional, mostly nasal, conjunctival retraction of 4-5 mm over the nano-fibre skirt was seen throughout follow-up. The anterior chamber was quiet and well-formed. No other postoperative complications were observed. CONCLUSION: This initial case may imply a potential breakthrough in the treatment of corneal disease not amenable to standard corneal transplant. Long follow-up and additional implantations are desired to prove the long-term safety and efficacy of this device.

Remote Surgeon Virtual Presence: A Novel Telementoring Method for Live Surgical Training.

PURPOSE: We describe the first known use of telementoring in corneal surgery and technology combining a 3-dimensional microscope system, 5G live streaming technology, group chat software, and a virtual reality headset for intercontinental surgical supervision. METHODS: Three surgeons in Toronto were proctored by a surgeon in Israel in the implantation of a novel keratoprosthesis device (CorNeat KPro; Ra'anana, Israel) into cadaver eyes. In Toronto, the NGENUITY platform (Alcon) transmitted high-definition, 3-dimensional images to the proctor in Israel who viewed the live video through a GOOVIS Virtual Reality headset with subsecond latency. This was made possible by the LiveU technology (Hackensack, NJ), which is a portable device to increase the bandwidth of transmission. The primary outcome was the successful completion of CorNeat KPro implantation. After each procedure, all surgeons completed a Likert scale questionnaire that assessed opinions on telementoring. RESULTS: All participants implanted the CorNeat KPro device. There was significant satisfaction reported. A total cumulative score from the questionnaire was 149 of 150 from the operating surgeons, with a score of 135 of 150 by the proctor. All felt that there was excellent AV quality with no lag time and recommended the technology. CONCLUSIONS: Telementoring is a promising tool that can traverse large distances for ophthalmic education.

CorNeat KPro: Ocular Implantation Study in Rabbits.

PURPOSE: The purpose of this study was to evaluate surgical feasibility and long-term integration of the CorNeat Keratoprosthesis (KPro), a novel synthetic cornea, in rabbits. METHODS: The CorNeat KPro is a synthetic corneal implant designed to treat corneal blindness by using a polymeric scaffold for biointegration, consequently assimilating synthetic optics within ocular tissues. Eight New Zealand White rabbits were implanted unilaterally with the CorNeat KPro and observed for 6 months. Animals were regularly monitored by a certified ophthalmologist using slit-lamp biomicroscopy. One animal developed postoperative endophthalmitis and was removed from the study 7 weeks postsurgery. At termination, eyes were enucleated and evaluated histologically to assess local tissue integration and inflammatory response. RESULTS: The surgical procedure was found feasible. The CorNeat KPro integrated into all operated eyes, resulting in a retention rate of 87.5% at the conclusion of the 6-month follow-up period. We observed minimal-to-mild conjunctival and iridial congestion and did not find additional inflammatory indicators, such as anterior chamber fibrin, flare, or cells. The optical element of the device remained clear with zero incidence of retroprosthetic membrane formation. Histopathological evaluation revealed comparable tissue and cellular reaction in all eyes, consisting of the presence of fibroblasts and associated collagen fibrils within the device's skirt component. Some eyes showed a mild foreign body reaction surrounding the skirt. CONCLUSIONS: Clinical and histological findings indicate the integration of the implanted device into the surrounding tissue, evident by the retention rate and the diffuse infiltration of fibroblasts with collagen deposition among the device's fibrils. These data hold promise for clinical application in humans.

Penetration of moxifloxacin through crosslinked corneas.

PURPOSE: To determine the ability of moxifloxacin to penetrate the rabbit eye after corneal collagen crosslinking (CXL) with riboflavin and ultraviolet-A light irradiation. SETTING: Harlan Biotech Israel, Rehovot, Israel. DESIGN: Experimental study. METHODS: One eye of 10 New Zealand white rabbits had CXL treatment. One month after treatment and 1 hour before an aqueous humor sample was obtained, 1 drop of 5 mg/mL moxifloxacin (Vigamox) was applied to both eyes of each rabbit every 15 minutes for a total of 4 drops. The aqueous humor samples were sent for high-performance liquid chromatography for antibiotic-concentration analysis. The eyes were enucleated and sent for histology analysis. RESULTS: Moxifloxacin levels were obtained and analyzed for all 20 eyes. The mean level of moxifloxacin was 2.26 µg/mL ± 0.89 (SD) (range 1.09 to 4.20 µg/mL) in the treated eyes and 2.43 ± 1.17 µg/mL (range 0.89 to 4.72 µg/mL) in the untreated eyes. The difference between the groups was not statistically significant. Of the 10 eye pairs, lower moxifloxacin aqueous humor concentrations were found in 6 treated eyes and 4 untreated eyes. CONCLUSION: Penetration of moxifloxacin into the anterior chamber of rabbits was not influenced by previous CXL treatment. FINANCIAL DISCLOSURES: No author has a financial or proprietary interest in any material or method mentioned.

Treatment of dry eye syndrome with orally administered CF101: data from a phase 2 clinical trial.

OBJECTIVE: To explore the safety and efficacy of CF101, an A(3) adenosine receptor agonist, in patients with moderate to severe dry eye syndrome. DESIGN: Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-group study. PARTICIPANTS: Sixty-eight patients completed the study, 35 patients in the placebo group and 33 patients in the CF101 group. INTERVENTION: Patients were treated orally with either 1 mg CF101 pills or matching vehicle-filled placebo pills, given twice daily for 12 weeks, followed by a 2-week posttreatment observation. MAIN OUTCOME MEASURES: An improvement of more than 25% over baseline at week 12 in one of the following parameters: (1) tear break-up time (BUT); (2) superficial punctate keratitis assessed by fluorescein staining results; and (3) Schirmer tear test 1 results. Clinical laboratory safety tests, ophthalmic examinations, intraocular pressure (IOP) measurements, electrocardiographic evaluations, vital sign measurements, and monitoring of adverse events. RESULTS: A statistically significant increase in the proportion of patients who achieved more than 25% improvement in the corneal staining and in the clearance of corneal staining was noted between the CF101-treated group and the placebo group. Treatment with CF101 resulted in a statistically significant improvement in the mean change from baseline at week 12 of the corneal staining, BUT, and tear meniscus (TM) height in the CF101-treated group. CF101 was well tolerated and exhibited an excellent safety profile with no serious adverse events. A statistically significant decrease from baseline was observed in the IOP of the CF101-treated group in comparison with the placebo group. CONCLUSIONS: CF101, given orally, induced a statistically significant improvement in the corneal staining and an improvement in the BUT and TM in patients with moderate to severe dry eye syndrome. The drug was very well tolerated. These data and the anti-inflammatory characteristic of CF101 support further study of the drug as a potential treatment for the signs and symptoms of dry eye syndrome. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.