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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - GLAUrious (External Automatic Glaucoma Laser (EAGLE) for the first-line glaucoma treatment:Commercial prototype development and validation)

Teaser

Summary

The GLAUrious project is clinically testing and validating the novel External Automatic Glaucoma Laser (EAGLE) device developed and patented by BELKIN Laser Ltd with the goal of providing accessible first-line treatment for glaucoma. This novel, non-contact method directs the beams deep into the sclera (the white part of the eye) around the limbus (the border between the colored and the white parts of the eye), a location which overlies the target tissue (trabecular meshwork). The instrument delivers laser applications automatically. This will enable treatment by this novel cost-effective device to be completed about a second in an automatic mode implementing image-acquisition technology, and could be performed by any ophthalmologist, not only glaucoma specialist.
About 64 million people worldwide suffer from glaucoma Which is a chronic disease causing progressive optic nerve degeneration, is the leading cause of irreversible blindness globally. Although incurable, disease progression can be arrested or delayed by reducing the pressure inside the eye, thus preventing visual incapacitation and blindness.
Current first-line treatment requires life-long daily eye drops, a strict regimen causing 50% patient dropout after 1 year. Laser treatment for glaucoma (Laser Trabeculoplasty, LTP) has been in use for many years. Its effect lasts for 2âˆ’5 years and is repeatable. This traditional 10-minute procedure, involving contact with the patientâ€™s eye, requires the expertise of glaucoma specialists. Consequently, costs are high and accessibility to the general population is low. The novel EAGLE procedure is automated, non-invasive, non-contact, painless and user friendlyâ€”1 second of treatment by one press of a button. This revolutionary cost-effective device could be safely used by all the worldâ€™s 212,000 ophthalmologists, thus becoming a primary treatment for glaucoma, overcoming serious problems of eye drop non-compliance and non-availability, thus effectively preventing disease deterioration. GLAUrious project aims to facilitate commercialization of the EAGLE device by securing clinical prototype validation, streamlining industrial production, optimizing component costs, disseminating to key opinion leaders and distributors, and refining commercial strategy. The multidisciplinary GLAUrious Consortium, with its four partners from three-member states (Belgium, Italy, UK) and one associated state (Israel), incorporates two SMEs and two academic hospitals.

The GLAUrious consortium aims to complete the final steps in development of the EAGLE device, namely clinical validation of the prototype, commercial prototype production by cost optimization of components, dissemination to key opinion leaders and distributors, and refinement of the commercial strategy. Successful validation of EAGLE will result in its commercialization enabling substantial penetration by this innovative product of the ophthalmic market.

Work performed

\"Main results achieved:
1. Partner BEL has completed the hardware and software design, integration and validation of EAGLE clinical prototype. 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 evaluation: 6-months data from patients that completed the study suggests that the Trans-scleral Direct SLT (DSLT) performed with EAGLE device seems to be a safe and effective method of reducing intra-ocular pressure (IOP) in open-angle glaucoma.
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 and UNIGE. The study is registered at ISRCTN registry #14033075, clinicaltrials.gov # NCT03750201. The study was approved by regulatory authorities in UK and Italy.
5. GLAUrious study has been initiated in Italy in University of Genova (partner UNIGE). First patients were treated; no Serious Adverse Events were reported.
6. The critical component of the EAGLE device is a compact inexpensive high repetition rate laser. Partner BEL worked with the selected laser producer for development a customized laser based on devised specifications to match the needs of EAGLE.

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Final results

The project will clinically validate the innovative and revolutionary EAGLE device for use as a first-line treatment for glaucoma, and finalize the development of a cost-effective commercial EAGLE device.
The projectâ€™s developmental path is devised to finalize the regulatory requirements for CE mark authorization prior to commercialization of a medical device in the EU. A CE mark, together with the clinical data obtained in the multicenter clinical trial, will support the market penetration.
At present, only a small minority of glaucoma patients are aware of the possibility of undergoing traditional laser irradiation as an initial treatment instead of enduring years of medical treatment. EAGLE is designed to make glaucoma laser treatment accessible through general ophthalmologists.
The innovative technology provides a solution not only for Open Angel Glaucoma (OAG, 74% of total glaucoma cases) but may also serve as an exclusive solution for Angle Closure Glaucoma (ACG, ~26%). ACG is most common among East Asian and Indian populations and is the leading cause of irreversible blindness in China.