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

NCT ID: NCT06953349

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Open-Angle Glaucoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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OMNI Hydrus Microstent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon, a Novartis Company

INDUSTRY

Sponsor Role collaborator

Barnet Dulaney Perkins Eye Centers

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Funke, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Barnet Dulaney Perkins Eye Centers

Locations

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Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Derek J Arnson, Master of Education

Role: CONTACT

4804201005

Christine Funke, Medical Doctor

Role: CONTACT

4804201005

Facility Contacts

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Derek J Arnson, Master of Education

Role: primary

4804201005

Christine Funke, Medical Doctor

Role: backup

4804201005

References

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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.

Reference Type BACKGROUND
PMID: 36813144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33315733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32657904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38983083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36544749 (View on PubMed)

Other Identifiers

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Alcon - IIT Proposal 95537309

Identifier Type: -

Identifier Source: org_study_id

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