Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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. Every patients will be followed for 24 months.
Secondary aims of the study are:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma | Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| IOP | IOP values before and after 24 months of XEN63 implant. | up to 2 years |
| Number of hypotensive eye drops | Number of hypotensive eye drops | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| IOP | IOP values before and after 12 months of XEN63 implant. | From enrollment to 12 months after surgery |
| Number of hypotensive eye drops | Number of hypotensive eye drops before and after 12 months of XEN63 implant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Glaucoma patients attending the hospital
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco Oddone, MD, PhD | IRCCS-Fondazione GB Bietti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ente ecclesiastico Ospedale Generale Regionale F. Miulli-Acquaviva delle Fonti Bari | Acquaviva delle Fonti | Italy | 70021 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33921311 | Background | Fea AM, Menchini M, Rossi A, Posarelli C, Malinverni L, Figus M. Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes. J Clin Med. 2021 Apr 12;10(8):1628. doi: 10.3390/jcm10081628. | |
| 28850575 | Background | Lavia C, Dallorto L, Maule M, Ceccarelli M, Fea AM. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis. PLoS One. 2017 Aug 29;12(8):e0183142. doi: 10.1371/journal.pone.0183142. eCollection 2017. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| From enrollment to 12 months after surgery |
| Complications | - Type and number of intraoperative and postoperative complications. | up to 2 years |
| Quality of life after XEN63 implant | Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25) scores over time. The minimum value is 0, the maximum value is 100. Higher score means a better outcome. | up to 2 years |
| Surgical tecnique | Data on surgical technique: site of XEN63 implant | during the intervention/procedure/surgery |
| Post operative management | Post operative treatment: type of steroids used | up to 2 years |
| Post operative needling | Number of needling | up to 2 years |
| Surgical revision | Number of surgical revision | up to 2 years |
| Glaucoma Symptom Scale | A brief symptom survey specific for persons with glaucoma. This score is transformed to a 0 to 100 scale, with 0 representing presence of a very bothersome problem and 100 representing absence of a problem. | up to 2 years |
| Surgical technique | Data on surgical technique: type of viscoelastic used | during the intervention/procedure/surgery |
| Post operative management | Type and number of hypotensive drops used to control IOP after surgery if needed. | up to 2 years |
| Ospedale della Murgia "Fabio Perinei" |
| Altamura |
| Italy |
| 70022 |
| Italy |
| Ospedale Santa Croce e Carle di Cuneo | Cuneo | Italy | 12100 | Italy |
| SOD Oculistica - AOU Careggi, Firenze | Florence | Italy | 50134 | Italy |
| AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da Saliceto | Piacenza | Italy | 29121 | Italy |
| Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari | Sassari | Italy | 07100 | Italy |
| UOC Oculistica Aulss 4, Ospedale di San Donà Di Piave. | Venezia | Italy | 30027 | Italy |
| Ospedale S. Andrea, S.O.C. Oculistica | Vercelli | Italy | Italy |
| ASST Papa Giovanni XXIII | Bergamo | Italy |
| Clinica Oculistica, Ospedale San Giovanni di Dio, Azienda Ospedaliero-Universitaria di Cagliari | Cagliari | Italy |
| Clinica Oculistica c/o Azienda Ospedale - Università di Padova | Padova | Italy |
| Dipartimento di Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche, Fondazione IRCCS policlinico San Matteo di Pavia | Pavia | Italy |
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G.D'Annunzio di Chieti-Pescara | Pescara | Italy |
| Clinica Oculistica Universitaria Ospedale Santa Chiara, AOUP-Ospedale Cisanello | Pisa | Italy |
| IRCCS-Fondazione GB Bietti | Rome | 00184 | Italy |
| CET Interaziendale AOU Città della Salute e della Scienza di Torino | Torino | Italy |
| Ospedale Ca'Foncello AULSS 2 Marca Trevigiana | Treviso | Italy |
| Azienda ospedaliera 'C.Panico' Tricase Lecce | Tricase | Italy |
| Day service di Oculistica del PPA "F.Fallacara" | Triggiano | Italy |
| 12799246 | Background | Fannin LA, Schiffman JC, Budenz DL. Risk factors for hypotony maculopathy. Ophthalmology. 2003 Jun;110(6):1185-91. doi: 10.1016/S0161-6420(03)00227-6. |
| 15118473 | Background | Bashford KP, Shafranov G, Shields MB. Bleb revision for hypotony maculopathy after trabeculectomy. J Glaucoma. 2004 Jun;13(3):256-60. doi: 10.1097/00061198-200406000-00015. |
| 24874999 | Background | Bitrian E, Song BJ, Caprioli J. Bleb revision for resolution of hypotony maculopathy following primary trabeculectomy. Am J Ophthalmol. 2014 Sep;158(3):597-604.e1. doi: 10.1016/j.ajo.2014.05.021. Epub 2014 May 27. |
| 15126172 | Background | Oyakhire JO, Moroi SE. Clinical and anatomical reversal of long-term hypotony maculopathy. Am J Ophthalmol. 2004 May;137(5):953-5. doi: 10.1016/j.ajo.2003.11.019. |
| 17542978 | Background | Costa VP, Arcieri ES. Hypotony maculopathy. Acta Ophthalmol Scand. 2007 Sep;85(6):586-97. doi: 10.1111/j.1600-0420.2007.00910.x. Epub 2007 Jun 2. |
| 15939389 | Background | Jampel HD, Musch DC, Gillespie BW, Lichter PR, Wright MM, Guire KE; Collaborative Initial Glaucoma Treatment Study Group. Perioperative complications of trabeculectomy in the collaborative initial glaucoma treatment study (CIGTS). Am J Ophthalmol. 2005 Jul;140(1):16-22. doi: 10.1016/j.ajo.2005.02.013. |