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| Name | Class |
|---|---|
| Alcon, a Novartis Company | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Benefits of the Surgical System and Phacoemulsification | • Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline | 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification |
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Inclusion Criteria:
Exclusion Criteria:
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300 subjects that have undergone CEIOL/OMNI/Hydrus
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek J Arnson, Master of Education | Contact | 4804201005 | derek.arnson@researchavp.com | |
| Christine Funke, Medical Doctor | Contact | 4804201005 | christine.funke@BDPEC.com |
| Name | Affiliation | Role |
|---|---|---|
| Christine Funke, Medical Doctor | Barnet Dulaney Perkins Eye Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Recruiting | Mesa | Arizona | 85206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36813144 | Background | 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. | |
| 33315733 | 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. |
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To report on surgical success after cataract surgery in ethnically diverse (Caucasian, Asian, African American, Hispanic, Tribal) patients with multiple glaucoma using combined MIGS procedures.
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
The investigators will allow fellow researchers access to the data as the investigators work to publish the findings.
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|
|
• Overall IOP reduction from baseline (mmHg)
| 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | • Overall medication reduction (#0-5) | 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | • Rate of mean deviation change (dB) | 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | • SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other) | 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | Additional Secondary Endpoint stratified by Complete or Qualified surgical success defined by the following:
| 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | • Overall medication reduction from baseline, measured at 12, 24 and 36 month timepoints | 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | • Overall IOP reduction from baseline, measured at 12, 24 and 36 month timepoints | 36 months |
| Additional Benefits of the Surgical System and Phacoemulsification | • Rate of mean deviation change from baseline to postop time points in Humphrey visual field tests | 36 months |
| 32657904 | 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. |
| 38983083 | 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. |
| 36544749 | 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. |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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