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

NCT06953349 | Recruiting

• 1 other identifier: Alcon - IIT Proposal 95537309
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Open-Angle Glaucoma

Keywords

Hydrus Microstent; OMNI Surgical System; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• Measured Efficacy of Surgical Process with Phacoemulsification

  Primary endpoint stratified by complete or qualified success: • Proportion of patients with complete success (%) - without the use of medications

  24 months

Secondary Outcomes (9)

• Additional Benefits of the Surgical System and Phacoemulsification

  36 months

• Additional Benefits of the Surgical System and Phacoemulsification

  36 months

• Additional Benefits of the Surgical System and Phacoemulsification

  36 months

• Additional Benefits of the Surgical System and Phacoemulsification

  36 months

• Additional Benefits of the Surgical System and Phacoemulsification

  36 months

Study Arms (1)

Single Group/Cohort retrospectively utilized

This will be 300 eyes that have undergone the combination of Phacoemulsification, OMNI Canaloplasty and Hydrus microstent that will successfully lower IOP in ethnically-diverse patients with Open Angle Glaucoma

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

Interventions

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

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

Also known as: OMNI, Hydrus Microstent

Single Group/Cohort retrospectively utilized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 subjects that have undergone CEIOL/OMNI/Hydrus

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barnet Dulaney Perkins Eye Centers: lead
• Alcon, a Novartis Company: collaborator

Study Sites (1)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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.

  PMID: 33315733 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Christine Funke, Medical Doctor

  Barnet Dulaney Perkins Eye Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek J Arnson, Master of Education

CONTACT

4804201005; derek.arnson@researchavp.com

Christine Funke, Medical Doctor

CONTACT

4804201005; christine.funke@BDPEC.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: May 1, 2025
• Study Start: March 31, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: IPD will be made available once the study data collection is complete tentatively 12/2025 for a period of 12 months, to tentatively 12/2026
• Access Criteria: The investigators will allow fellow researchers access to the data as the investigators work to publish the findings.

Locations

US (1)