A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma

Not Applicable

Terminated

Conditions: Glaucoma, Open-Angle

Interventions: Device: OMNI® Surgical System

Registration Number: NCT04465630

Lead Sponsor: Sight Sciences, Inc.

Brief Summary: To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 78

Inclusion Criteria

Male or female subjects, 22 years or older at the time of surgery
History of uncomplicated cataract surgery and posterior chamber IOL implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit.
Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record substantiated using funduscopic exam or OCT and at least one visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
- Mean deviation score must be better than or equal to -12.0 dB
- The visual field test may be historical (within 6 months prior to Screening Visit). If needed, visual field testing may be repeated between the Screening Visit and the Surgery Visit.
At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1 with a stable medication regimen for at least 2 months.
At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least 3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24
Scheduled for ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
Shaffer grade of ≥ III in all four quadrants
Able and willing to comply with the protocol, including all follow-up visits.
Understands and signs the informed consent

Exclusion Criteria

Any of the following prior treatments for glaucoma:
- Laser trabeculoplasty ≤3 months prior to Baseline visit
- iStent or iStent Inject implanted ≤6 months prior to Baseline visit
- Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to Baseline visit
- Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
- Prior canaloplasty, goniotomy, or trabeculotomy
- Hydrus microstent
- Suprachoroidal stent (e.g. Cypass, iStent Supra)
Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.)
In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
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).
History of penetrating keratoplasty or another corneal transplant
BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract
Study of OMNI System in POAG
BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular opacification (uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is permitted only if there is no vitreous present in or in front of the iris plane at the time of baseline).
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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pseudophakic eyes with Open Angle Glaucoma	OMNI® Surgical System	Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP)	6 months	Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure

Secondary Outcome Measures

Name	Time	Method
Change in Number of Medications	6 months	Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure

Trial Locations

Locations (11): Assil Eye Institute
🇺🇸
Santa Monica, California, United States
Utah Eye Centers
🇺🇸
Ogden, Utah, United States
Vold Vision
🇺🇸
Fayetteville, Arkansas, United States
Grene Vision Group
🇺🇸
Wichita, Kansas, United States
North Bay Eye Associates
🇺🇸
Petaluma, California, United States
Visionary Eye Institute
🇺🇸
Newport Beach, California, United States
Minnesota Eye Consultants
🇺🇸
Bloomington, Minnesota, United States
Oklahoma Eye Surgeons
🇺🇸
Oklahoma City, Oklahoma, United States
University Eye Specialists
🇺🇸
Maryville, Tennessee, United States
El Paso Eye Surgeons
🇺🇸
El Paso, Texas, United States
Ophthalmology Associates - Fort Worth
🇺🇸
Fort Worth, Texas, United States