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Recruiting NCT06953349

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

— Observational Open-Angle Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis.
Who it may be relevant to
Registry conditions: Open-Angle Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Procedure 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

Primary outcome measures

  • Measured Efficacy of Surgical Process with Phacoemulsification [Time frame: 24 months]
Secondary outcome measures (9)
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]
  • Additional Benefits of the Surgical System and Phacoemulsification [Time frame: 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Barnet Dulaney Perkins Eye Center — Mesa

Publications

  • 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

Identifiers

NCT: NCT06953349 · Alcon - IIT Proposal 95537309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗