"Main results achieved during the project:
1. Partner BEL has completed the hardware and software design, integration and validation of EAGLE clinical prototypes. The device electrical, laser safety and software validation were performed to meet the Essential requirements and EU regulations.
2. Pre-clinical evaluation: Successful device performance achieved, all treated eyes of Dutch Belted rabbits as well as the control eyes showed normal histology with no changes.
3. First-in Human Clinical trial has been completed at Sheba Medical Center, Israel. The results suggest that the automated DSLT seems to be a safe and effective method of reducing intra-ocular pressure (IOP) in open-angle glaucoma. The results of the study are submitted for review at Ophthalmology, one of the leading ophthalmology journals.
4. Project partners and medical advisors developed the clinical protocol of the multicenter randomized, controlled, masked study to demonstrate non-inferiority of Direct Selective Laser Trabeculoplasty (DSLT) compared to Selective Laser Trabeculoplasty (SLT) to be performed by partners QUB (at Belfast City Hospital) and UNIGE (at the Eye Clinic, Genova University), and clinical subcontractors, Moorfeilds Eye Hospital (UK) and Beilinson Hospital (Israel). The study was approved by regulatory and ethical authorities in UK, Italy and Israel (ISRCTN registry #14033075, clinicaltrials.gov # NCT03750201).
5. GLAUrious study has been initiated in Italy in Eye Clinic, University of Genova (partner UNIGE), Belfast Hospital (partner QUB) and in Moorfeilds Eye hospital. 40 patients were recruited during the course of the study, 27 underwent the treatment. No Serious Adverse Events were reported. The trial will continue after the course of the project.
6. During the course of the project, the commercial prototype of EAGLE device has been produced to validate the device sub-systems performance. Based on the verification and validation results, an additional design cycle will be performed for manufacturing of the final commercial prototype. If no foundations for design updates are found, it will be used for the completion of the final commercial system manufacturing file and the commercial system production towards CE approval and the product launch.
7. Exploitation and dissemination activities: the commercial device development has led to three new patent applications to protect IP covering DSLT device, its image-processing algorithms and safety features. During the project, the method’s concept and the results of the FIH study have been presented at several Bio-optics and Ophthalmology conferences. Two manuscripts have been prepared for publication:
1). Submitted for review: Mordechai Goldenfeld, Michael Belkin, Masha Dobkin-Bekman, Zachary Sacks, Sharon Blum Meirovitch, Noa Geffen, Ari Leshno, Alon Skaat. Automated Direct Selective Laser Trabeculoplasty:
First-in-Human Prospective Clinical Trial, 2020 (submitted for review, Ophthalmology, 2020).
2). Published : Zachary Sacks, Masha Dobkin-Bekman, Noa Geffen, Mordechai Goldenfeld, Michael Belkin, Non-contact direct selective laser trabeculoplasty: light propagation analysis. Biomed. Opt. Express 11, 2889-2904 (2020)."
