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The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyes receiving OMNI intervention after medication washout |
| ||
| Eyes receiving OMNI intervention without medication washout |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNI® Surgical System | Device | The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) | Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline. | 18 months |
| Change in Number of Medications | Mean change in the number of ocular hypotensive medications compared to baseline. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Specialists of Georgia | Atlanta | Georgia | 30315 | United States | ||
| Grene Vision Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Washout | Eyes receiving OMNI intervention after medication washout. |
| FG001 | No Washout | Eyes receiving OMNI intervention without medication washout |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2021 |
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|
| Wichita |
| Kansas |
| 62708 |
| United States |
| Minnesota Eye Consultants | Bloomington | Minnesota | 55431 | United States |
| Northern New Jersey Eye Institute | Orange | New Jersey | 07079 | United States |
| Oklahoma Eye Surgeons | Oklahoma City | Oklahoma | 73112 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79902 | United States |
| Ophthalmology Associates - Fort Worth | Fort Worth | Texas | 76102 | United States |
| Utah Eye Centers | Ogden | Utah | 84403 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Washout | Eyes receiving OMNI intervention after medication washout. |
| BG001 | No Washout | Eyes receiving OMNI intervention without medication washout |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intraocular Pressure (IOP) | Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline. | Intent To Treat | Posted | Mean | Standard Deviation | percent change | 18 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change in Number of Medications | Mean change in the number of ocular hypotensive medications compared to baseline. | Intent To Treat | Posted | Mean | Standard Deviation | number of medications | 18 months |
|
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Washout | Eyes receiving OMNI intervention after medication washout. | 0 | 18 | 0 | 18 | 12 | 18 |
| EG001 | No Washout | Eyes receiving OMNI intervention without medication washout | 1 | 10 | 1 | 10 | 7 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Cause unknown |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOP increase above baseline at 1mont or greater | Eye disorders | Systematic Assessment | IOP increase >=10 mmHg above baseline IOP at >=1 month visit |
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| Layered Hyphema | Eye disorders | Systematic Assessment |
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| Secondary Surgical Intervention | Eye disorders | Systematic Assessment |
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| Corneal edema after 1 week | Eye disorders | Systematic Assessment |
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| IOL dislocation and/or damage | Eye disorders | Systematic Assessment |
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| Posterior capsular opacification | Eye disorders | Systematic Assessment |
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| Iridodialysis or significant iris damage | Eye disorders | Systematic Assessment |
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| Conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Corneal epithelial microcysts | Eye disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Dry Eye | General disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Glaucoma | Eye disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Intraocular pressure increased | Eye disorders | Systematic Assessment |
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| Iridocele | Eye disorders | Systematic Assessment |
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| Iris adhesions | Eye disorders | Systematic Assessment |
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| Iris atrophy | Eye disorders | Systematic Assessment |
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| Iris transillumination defect | Eye disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Pigment dispersion syndrome | Eye disorders | Systematic Assessment |
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| Punctate keratitis | Eye disorders | Systematic Assessment |
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| Pupillary reflex impaired | Eye disorders | Systematic Assessment |
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| Retinal drusen | Eye disorders | Systematic Assessment |
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| Sinus pain | General disorders | Systematic Assessment |
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After Sponsor's publication of trial results, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to the obligations of the CTA, and prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure at least 60 days prior to submission for publication or disclosure. Sponsor may request changes or other measures to ensure the information is fairly stated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Medical and Clinical Affairs | Sight Sciences, Inc. | 1-877-266-1144 | jdickerson@sightsciences.com |
| Mar 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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