Clinical trial NCT06953349: Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis
Official title: Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open-Angle Glaucoma
Keywords: Hydrus Microstent
OMNI Surgical System
Phacoemulsification
Lead sponsor: Barnet Dulaney Perkins Eye Centers
Sponsor class: NETWORK
Collaborators: name: Alcon, a Novartis Company
First posted: 2025-05-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 subjects that have undergone CEIOL/OMNI/Hydrus

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

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measured Efficacy of Surgical Process with Phacoemulsification
timeFrame: 24 months
Secondary outcomes:
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
measure: Additional Benefits of the Surgical System and Phacoemulsification
timeFrame: 36 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
Study officials:
affiliation: Barnet Dulaney Perkins Eye Centers
name: Christine Funke, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.0000000000000552.
citation: 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.
citation: 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.
citation: 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.