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

Prospective, Multi-Center, Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).

Study Overview

• Status: Unknown
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: Transluminal viscoelastic delivery and trabeculotomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kavita p Dhamdhere, MD, PhD; Phone Number: 16502234062; Email: kdhamdhere@sightsciences.com
• Study Contact Backup: Name: Anne Ripley; Phone Number: 6616458546; Email: anne@sightsciences.com

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Eye Surgeons
      • Contact: Mark Gallardo, MD; Phone Number: 915-542-0279; Email: gallardomark@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viscoeleastic delivery & trabeculotomy; Patients with open angle glaucoma and cataract	Device: Transluminal viscoelastic delivery and trabeculotomy; Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean unmedicated diurnal IOP	Reduction in mean unmedicated diurnal IOP from baseline to 12 months	12 months
Change in mean number of IOP-lowering medications	Reduction in mean number of IOP-lowering medications from screening to 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months	12 months
Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint- Adverse events	Rates of ocular adverse events (intraoperative, postoperative)	12 months
Safety Endpoint- best corrected visual acuity	Reduction in best corrected visual acuity (BCVA) from baseline (note: reduction in BCVA due to PCO will not be treated as a safety event)	12 months

Collaborators and Investigators

• Sponsor: Sight Sciences, Inc.
• Investigators: Study Director: kavita p dhamdhere, MD, PhD, Sight Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract
• Other Study ID Numbers: 06213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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