Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis

Официальное название

Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis

Обзор

Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis

Подробное описание

The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma

Вмешательства

• Процедура Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
  The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma

Первичные конечные точки

• Measured Efficacy of Surgical Process with Phacoemulsification [Срок оценки: 24 months]

Вторичные конечные точки (9)

• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]
• Additional Benefits of the Surgical System and Phacoemulsification [Срок оценки: 36 months]

Критерии участия

Критерии включения

• Subjects with h/o CEIOL/OMNI/Hydrus (chosen based on subjects on more than 1 medication pre-operatively) with at least 3 years of follow up data
• have Glaucoma

Критерии исключения

• Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
• Patients with refractory CME or CME persisting 3 months or more post-operatively
• Patients with incomplete IOP, medication logs or VF data within post-operative period
• Prior incisional surgery or MIGS

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Barnet Dulaney Perkins Eye Center — Mesa

Публикации

• Montesano G, Ometto G, Ahmed IIK, Ramulu PY, Chang DF, Crabb DP, Gazzard G. Five-Year Visual Field Outcomes of the HORIZON Trial. Am J Ophthalmol. 2023 Jul;251:143-155. doi: 10.1016/j.ajo.2023.02.008. Epub 2023 Feb 21. PMID 36813144
• Hirsch L, Cotliar J, Vold S, Selvadurai D, Campbell A, Ferreira G, Aminlari A, Cho A, Heersink S, Hochman M, Gallardo M, Williamson B, Phan R, Nelson C, Dickerson JE Jr. Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. J Cataract Refract Surg. 2021 Jul 1;47(7):907-915. doi: 10.1097/j.jcrs.0 PMID 33315733
• Sarkisian SR Jr, Radcliffe N, Harasymowycz P, Vold S, Patrianakos T, Zhang A, Herndon L, Brubaker J, Moster R, Francis B; ASCRS Glaucoma Clinical Committee. Visual outcomes of combined cataract surgery and minimally invasive glaucoma surgery. J Cataract Refract Surg. 2020 Oct;46(10):1422-1432. doi: 10.1097/j.jcrs.0000000000000317. PMID 32657904
• Laroche D, Desrosiers A, Ng C. Short-term report of early glaucoma surgery with a clear lens extraction and an intraocular lens, OMNI canaloplasty, and a HYDRUS microstent: a case series in younger patients. Front Ophthalmol (Lausanne). 2024 Jan 5;3:1288052. doi: 10.3389/fopht.2023.1288052. eCollection 2023. PMID 38983083
• Creagmile J, Kim WI, Scouarnec C. Hydrus Microstent implantation with OMNI Surgical System Ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy. Am J Ophthalmol Case Rep. 2022 Nov 10;29:101749. doi: 10.1016/j.ajoc.2022.101749. eCollection 2023 Mar. PMID 36544749

Идентификаторы

NCT: NCT06953349 · Alcon - IIT Proposal 95537309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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