Glaucoma, Open-Angle
Conditions
Brief summary
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.
Interventions
DEVICEOMNI® Surgical System
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.
Sponsors
Sight Sciences, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment.
Exclusion criteria
* Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits. * Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) | 18 months | Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline. |
| Change in Number of Medications | 18 months | Mean change in the number of ocular hypotensive medications compared to baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Washout Eyes receiving OMNI intervention after medication washout. | 18 |
| No Washout Eyes receiving OMNI intervention without medication washout | 10 |
| Total | 28 |
Baseline characteristics
| Characteristic | Washout | Total | No Washout |
|---|---|---|---|
| Age, Continuous | 75.0 years STANDARD_DEVIATION 8.2 | 75.4 years STANDARD_DEVIATION 7 | 76.0 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 21 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 21 Participants | 4 Participants |
| Region of Enrollment United States | 18 participants | 28 participants | 10 participants |
| Sex: Female, Male Female | 11 Participants | 18 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 1 / 10 |
| other Total, other adverse events | 12 / 18 | 7 / 10 |
| serious Total, serious adverse events | 0 / 18 | 1 / 10 |
Outcome results
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.
Time frame: 18 months
Population: Intent To Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Washout | Change in Intraocular Pressure (IOP) | 38.2 percent change | Standard Deviation 15.53 |
| No Washout | Change in Intraocular Pressure (IOP) | 30.1 percent change | Standard Deviation 24.14 |
Primary
Change in Number of Medications
Mean change in the number of ocular hypotensive medications compared to baseline.
Time frame: 18 months
Population: Intent To Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Washout | Change in Number of Medications | -1.13 number of medications | Standard Deviation 1.06 |
| No Washout | Change in Number of Medications | -0.13 number of medications | Standard Deviation 1.25 |