Studies a gel implant for glaucoma that is not controlled by eye drops
Tests the XEN63 gel implant in adults with glaucoma needing surgery for eye pressure.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of XEN63 Gel Implant
Key facts
- Where
- Acquaviva delle Fonti, Altamura, Bergamo, Cagliari, Cuneo, Florence, Padova, Pavia, Pescara, Piacenza, Pisa, Rome, Sassari, Torino, Treviso, Tricase, Triggiano, Venezia, and Vercelli, ItalySee the 19 sites
Where in Italy
- Ente ecclesiastico Ospedale Generale Regionale F. Miulli-Acquaviva delle Fonti BariAcquaviva delle Fonti, ItalyNo longer taking part
- Ospedale della Murgia "Fabio Perinei"Altamura, ItalyNo longer taking part
- Asst Papa Giovanni XXIIIBergamo, ItalyNo longer taking part
- Clinica Oculistica, Ospedale San Giovanni di Dio, Azienda Ospedaliero-Universitaria di CagliariCagliari, ItalyNo longer taking part
- Ospedale Santa Croce e Carle di CuneoCuneo, ItalyNo longer taking part
- SOD Oculistica - AOU Careggi, FirenzeFlorence, ItalyNo longer taking part
- Clinica Oculistica c/o Azienda Ospedale - Università di PadovaPadova, ItalyNo longer taking part
- Dipartimento di Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche, Fondazione IRCCS policlinico San Matteo di PaviaPavia, ItalyNo longer taking part
- Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G.D'Annunzio di Chieti-PescaraPescara, ItalyNo longer taking part
- AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da SalicetoPiacenza, ItalyNo longer taking part
- Clinica Oculistica Universitaria Ospedale Santa Chiara, AOUP-Ospedale CisanelloPisa, ItalyNo longer taking part
- IRCCS-Fondazione GB BiettiRome, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di SassariSassari, ItalyNo longer taking part
- CET Interaziendale AOU Città della Salute e della Scienza di TorinoTorino, ItalyNo longer taking part
- Ospedale Ca'Foncello AULSS 2 Marca TrevigianaTreviso, ItalyNo longer taking part
- Azienda ospedaliera 'C.Panico' Tricase LecceTricase, ItalyNo longer taking part
- Day service di Oculistica del PPA "F.Fallacara"Triggiano, ItalyNo longer taking part
- UOC Oculistica Aulss 4, Ospedale di San Donà Di Piave.Venezia, ItalyNo longer taking part
- Ospedale S. Andrea, S.O.C. OculisticaVercelli, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mario Stirpe
- Trial code
- NCT06844240
- Record updated
- 1 June 2026
- Original description
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.Read full original descriptionShow less
Efficacy and Safety of the XEN63: a Prospective Observational Multicenter Study.
The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.
Inclusion: Age ≥ 18 years; Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines; Need for XEN63 implantation for IOP not controlled by medical therapy, progression of disease or intolerance to topical therapy, in association or not with cataract surgery; Informed consent freely given and obtained before the start of the study; The participant has the ability to understand and the willingness to follow the study instructions and is likely to complete all required visits and procedures.
Exclusion: Previous trabeculectomy or valve or tube placement; Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant; Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery; Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos); Known or suspected allergy or sensitization to medications required for the surgical procedure or some component of the device (e.g. glutaraldehyde or porcine derivatives); History of predisposition to the formation of keloids; Closed-angle glaucoma; Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis); Anterior chamber lenses; Presence of intraocular silicone oil; Vitreous in anterior chamber; Pregnancy or breastfeeding.