Efficacy and Safety of XEN63 Gel Implant

Официальное название

Efficacy and Safety of the XEN63: a Prospective Observational Multicenter Study.

Обзор

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.

Подробное описание

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:

* Evaluating the hypotensive efficacy of the XEN63 12 months after implantation. * Assessing the safety of the XEN63 device after 12 and 24 months after implantation. * Comparing the hypotensive efficacy of the XEN63 in glaucomatous patients undergoing the solo procedure and in those undergoing the combo procedure * Evaluating the quality of life of patients undergoing XEN63 implantation 12 and 24 months after implantation. * Evaluating the association between factors related to the patient, the surgical technique or post-operative management and the hypotensive efficacy of the device during follow-up.

Первичные конечные точки

• IOP [Срок оценки: up to 2 years]
• Number of hypotensive eye drops [Срок оценки: up to 2 years]

Вторичные конечные точки (11)

• IOP [Срок оценки: From enrollment to 12 months after surgery]
• Number of hypotensive eye drops [Срок оценки: From enrollment to 12 months after surgery]
• Complications [Срок оценки: up to 2 years]
• Quality of life after XEN63 implant [Срок оценки: up to 2 years]
• Surgical tecnique [Срок оценки: during the intervention/procedure/surgery]
• Post operative management [Срок оценки: up to 2 years]
• Post operative needling [Срок оценки: up to 2 years]
• Surgical revision [Срок оценки: up to 2 years]
• Glaucoma Symptom Scale [Срок оценки: up to 2 years]
• Surgical technique [Срок оценки: during the intervention/procedure/surgery]
• Post operative management [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Closed-angle glaucoma
• 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.
• Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
• Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery
• Anterior chamber lenses
• Presence of intraocular silicone oil
• Vitreous in anterior chamber
• 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.
• Pregnancy or breastfeeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 19 центров

• Ente ecclesiastico Ospedale Generale Regionale F. Miulli-Acquaviva delle Fonti Bari — Acquaviva delle Fonti
• Ospedale della Murgia "Fabio Perinei" — Altamura
• Ospedale Santa Croce e Carle di Cuneo — Cuneo
• SOD Oculistica - AOU Careggi, Firenze — Florence
• AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da Saliceto — Piacenza
• Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmac — Sassari
• UOC Oculistica Aulss 4, Ospedale di San Donà Di Piave. — Venezia
• Ospedale S. Andrea, S.O.C. Oculistica — Vercelli
• … и ещё 11 центров

Публикации

• 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. PMID 33921311
• 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. PMID 28850575
• 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. PMID 12799246
• 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. PMID 15118473
• 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. PMID 24874999
• 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. PMID 15126172
• 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. PMID 17542978
• 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. PMID 15939389

Идентификаторы

NCT: NCT06844240 · GLC06-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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