Clinical trial NCT03861169: Study of OMNI System in OAG (GEMINI)
Official title: Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 209
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: Inclusion Criteria:

Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied 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) as documented in subjects' medical record per ICD-10 guidelines
4. At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit
5. At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP
6. Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
7. Shaffer grade of ≥ 3 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. Understood and signed the informed consent

Exclusion Criteria:

All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.

1. Any of the following prior treatments for glaucoma:

   * Laser trabeculoplasty ≤ 3 months prior to baseline
   * Implanted with iStent, 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 as documented in subjects' medical record per ICD-10 guidelines
5. Use of oral hypotensive medication treatment for glaucoma
6. In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
7. 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)
8. 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
9. 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

Primary outcomes:
measure: Change in Mean Unmedicated Diurnal IOP
timeFrame: 12 months
measure: Change in Mean Number of IOP-Lowering Medications
timeFrame: 12 months
Secondary outcomes:
measure: Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP
timeFrame: 12 months
measure: Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Lake Havasu City
country: United States
facility: Barnet Delaney Perkins Eye Center
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Weston
country: United States
facility: Your Eye Specialists
state: Florida
city: Atlanta
country: United States
facility: Omni Eye Services
state: Georgia
city: Iowa City
country: United States
facility: Eye Physicians and Surgeons, LLP
state: Iowa
city: Wichita
country: United States
facility: Grene Vision Group
state: Kansas
city: Bozeman
country: United States
facility: Vance Thompson Vision - MT
state: Montana
city: Omaha
country: United States
facility: Vance Thompson Vision - NE
state: Nebraska
city: W. Fargo
country: United States
facility: Vance Thompson Vision - ND
state: North Dakota
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons
state: Oklahoma
city: Jenkintown
country: United States
facility: Northern Ophthalmics
state: Pennsylvania
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Kenosha
country: United States
facility: Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Sight Sciences
name: Jaime Dickerson, PhD
role: STUDY_DIRECTOR
References: