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

NCT04465630 | Terminated Results FDA Device

• 1 other identifier: 06807
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 11

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).

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP)

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

  6 months

Secondary Outcomes (1)

• Change in Number of Medications

  6 months

Study Arms (1)

Pseudophakic eyes with Open Angle Glaucoma

OTHER

Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.

Device: OMNI® Surgical System

Interventions

OMNI® Surgical System DEVICE

Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System

Pseudophakic eyes with Open Angle Glaucoma

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (11)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Visionary Eye Institute

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Assil Eye Institute

Santa Monica, California, 90404, United States

Location

Grene Vision Group

Wichita, Kansas, 62708, United States

Location

Minnesota Eye Consultants

Bloomington, Minnesota, 55431, United States

Location

Oklahoma Eye Surgeons

Oklahoma City, Oklahoma, 73112, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

El Paso Eye Surgeons

El Paso, Texas, 79902, United States

Location

Ophthalmology Associates - Fort Worth

Fort Worth, Texas, 76102, United States

Location

Utah Eye Centers

Ogden, Utah, 84403, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Limitations and Caveats

Meaningful conclusions cannot be drawn due to early termination of the study due to a business decision.

Results Point of Contact

• Title: Kavita Dhamdhere, MD
• Organization: SIght Sciences, Inc

kdhamdhere@sightsciences.com

877-266-1144

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: June 19, 2020
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: June 28, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)