Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

This prospective, multicenter, single‐arm, post‐market clinical study will evaluate the
impact of ab‐interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical
System in conjunction with cataract surgery on IOP and the use of hypotensive medications in
patients with mild to moderate open angle glaucoma.

Inclusion Criteria:

- (only one eye of each subject is eligible, and all ocular criteria apply to the study
eye):

1. Male or female subjects, 22 years or older.

2. Visually significant cataract

3. Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma,
pigmentary glaucoma, pseudoexfoliative glaucoma) per AAO/AGS/ICD‐10 Glaucoma Stage
Definitions.1

4. At screening, on 1‐3 IOP‐lowering medications2 with a medicated IOP ≤25 mmHg OR on
zero (0) IOP‐lowering medications with an IOP 21‐30 mmHg.

5. At baseline, unmedicated diurnal IOP 21‐30 mmHg and, for subjects who were medicated
at screening, IOP at least 3 mmHg higher than screening IOP.

6. Scheduled for cataract extraction followed by abinterno transluminal viscoelastic
delivery and trabeculotomy using the OMNI Surgical System.

7. Shaffer grade of ≥ III in all four quadrants

8. Potential of good best corrected visual acuity post cataract extraction, in the
investigator's judgment

9. Able and willing to comply with the protocol, including all follow‐up visits.

10. Understands and signs the informed consent.

Exclusion Criteria:

- (All criteria apply to the study eye; both eyes of a single subject need not be
eligible):

1. Any of the following prior treatments for glaucoma:

- Laser trabeculoplasty ≤3 months prior to baseline

- iStent implanted ≤6 months prior to baseline

- Implanted with Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus
Device

- Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC

2. Normal tension glaucoma

3. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma

4. Severe glaucoma by AAO/AGS/ICD‐10 guideline

5. Use of oral hypotensive medication treatment for glaucoma

6. History of elevated IOP due to steroid response

7. In the investigator's judgement, predisposed to significant risk because of washout of
ocular hypotensive medications.

8. Ocular pathology or 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, etc.), or interfere with compliance to
elements of the study protocol (e.g., returning to investigator's office for follow‐up
visits).

9. 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.