Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
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ClinicalTrials.gov Identifier: NCT03861169 |
Recruitment Status :
Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Open Angle Glaucoma | Device: Transluminal viscoelastic delivery and trabeculotomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Multi-Center, Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma |
Actual Study Start Date : | February 22, 2019 |
Estimated Primary Completion Date : | August 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Viscoeleastic delivery & trabeculotomy
Patients with open angle glaucoma and cataract
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Device: Transluminal viscoelastic delivery and trabeculotomy
Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System |
- Change in mean unmedicated diurnal IOP [ Time Frame: 12 months ]Reduction in mean unmedicated diurnal IOP from baseline to 12 months
- Change in mean number of IOP-lowering medications [ Time Frame: 12 months ]Reduction in mean number of IOP-lowering medications from screening to 12 months
- Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months [ Time Frame: 12 months ]
- Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months [ Time Frame: 12 months ]
- Safety Endpoint- Adverse events [ Time Frame: 12 months ]Rates of ocular adverse events (intraoperative, postoperative)
- Safety Endpoint- best corrected visual acuity [ Time Frame: 12 months ]Reduction in best corrected visual acuity (BCVA) from baseline (note: reduction in BCVA due to PCO will not be treated as a safety event)

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Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- (only one eye of each subject is eligible, and all ocular criteria apply to the study eye):
- Male or female subjects, 22 years or older.
- Visually significant cataract
- 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
- 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.
- 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.
- Scheduled for cataract extraction followed by abinterno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
- Shaffer grade of ≥ III in all four quadrants
- 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.
- 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):
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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
- Normal tension glaucoma
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Severe glaucoma by AAO/AGS/ICD-10 guideline
- Use of oral hypotensive medication treatment for glaucoma
- History of elevated IOP due to steroid response
- In the investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications.
- 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).
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861169
Contact: Kavita p Dhamdhere, MD, PhD | 16502234062 | kdhamdhere@sightsciences.com | |
Contact: Anne Ripley | 6616458546 | Anne@sightsciences.com |
United States, Texas | |
El Paso Eye Surgeons | Recruiting |
El Paso, Texas, United States, 79902 | |
Contact: Mark Gallardo, MD 915-542-0279 gallardomark@hotmail.com |
Study Director: | kavita p dhamdhere, MD, PhD | Sight Sciences |
Responsible Party: | Sight Sciences, Inc. |
ClinicalTrials.gov Identifier: | NCT03861169 |
Other Study ID Numbers: |
06213 |
First Posted: | March 4, 2019 Key Record Dates |
Last Update Posted: | March 4, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Glaucoma Cataract Glaucoma, Open-Angle |
Ocular Hypertension Eye Diseases Lens Diseases |