Glaucoma, Open-Angle
Conditions
Brief summary
First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.
Detailed description
A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.
Interventions
DEVICECanaloplasty and trabeculotomy with the OMNI system.
Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy
DEVICEiStent inject
Ab-interno implantation of iStent inject (2 microstents)
DEVICECanaloplasty
Ab-interno canaloplasty (360 degrees) using the OMNI
Sponsors
Sight Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 18 years or older 2. Pseudophakic 3. Diagnosis of open angle glaucoma (OAG) 4. On 1-5 ocular hypotensive medications
Exclusion criteria
1. Any of the following prior treatments for glaucoma: * Suprachoroidal stent (e.g. Cypass, iStent Supra) * Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass * Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve * Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome * Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU) 2. Any other form of glaucoma other than OAG 3. 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). 4. 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 |
|---|---|---|
| Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination | 12 months | Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications. |
Countries
Germany, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OMNI-Canaloplasty Only All subjects for whom the OMNI (canaloplasty alone) is attempted | 5 |
| OMNI-canaloplasty + Trabeculotomy All subjects for whom the OMNI (canaloplasty+trabeculotomy) is attempted | 1 |
| iStent Inject All subjects for whom the iStent inject is attempted | 4 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study terminated | 5 | 1 | 4 |
Baseline characteristics
| Characteristic | OMNI-canaloplasty + Trabeculotomy | Total | OMNI-Canaloplasty Only | iStent Inject |
|---|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 0 | 74.7 years STANDARD_DEVIATION 4 | 75.6 years STANDARD_DEVIATION 3.5 | 74.5 years STANDARD_DEVIATION 5.1 |
| Diurnal IOP (DIOP) | 26 mm Hg STANDARD_DEVIATION 0 | 26.8 mm Hg STANDARD_DEVIATION 3.8 | 29.0 mm Hg STANDARD_DEVIATION 4.4 | 24.3 mm Hg STANDARD_DEVIATION 0.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 6 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 9 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Poland | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Spain | 1 participants | 7 participants | 4 participants | 2 participants |
| Region of Enrollment United Kingdom | 0 participants | 2 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 3 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 / 5 | 0 / 1 | 0 / 4 |
| other Total, other adverse events | 3 / 5 | 1 / 1 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 1 | 0 / 4 |
Outcome results
Primary
Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
Time frame: 12 months
Population: Results are not presented for this outcome as no subjects had reached the primary endpoint of Month 12 at the time of study termination.