Glaucoma, Open-Angle
Conditions
Brief summary
To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.
Detailed description
First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)
Interventions
DEVICEOMNI® Surgical System
Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
DEVICEiStent inject
Trabecular meshwork implantation
Sponsors
Sight Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, 22 years or older * Visually significant cataract * Mild to moderate open angle glaucoma * On 1-5 IOP-lowering medications * Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment * Able and willing to comply with the protocol, including all follow-up visits. * Understand and sign the informed consent.
Exclusion criteria
* Any of the following prior treatments for glaucoma: * Laser trabeculoplasty ≤3 months prior to baseline * Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC * Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record. * Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits). * Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator * Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unmedicated Diurnal Intraocular Pressure (DIOP) | 1 week | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline | 1 week | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. |
| Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive | 1 week | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. |
| Change in the Number of Ocular Hypotensive Medications Compared to Screening | 1 week | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. |
| Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline | 1 week | The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System | 1 |
| Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System | 0 |
| iStent Inject Implantation iStent inject: Trabecular meshwork implantation | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Total | Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System |
|---|---|---|
| Age, Continuous | 66 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Sex/Gender, Customized Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Population: No subjects were analyzed is for the 2 arms that did not have any subjects treated in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System | Change in Unmedicated Diurnal Intraocular Pressure (DIOP) | 13.3 mmHg |
Secondary
Change in the Number of Ocular Hypotensive Medications Compared to Screening
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Population: The number analyzed is zero for 2 arms in the study that did not have any treatments
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System | Change in the Number of Ocular Hypotensive Medications Compared to Screening | 1 number of hypotensive medications |
Secondary
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Population: The number analyzed is zero for 2 arms in the study that did not have any subjects treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System | Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline | 13.3 mmHg |
Secondary
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Population: The number analyzed is zero for the 2 arms of the study that did not treat any subjects/Eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System | Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline | 1 Eyes |
Secondary
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Time frame: 1 week
Population: The number analyzed is zero for 2 arms in the study which had no subjects treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System | Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive | 1 Eyes |