Study of OMNI System in OAG (GEMINI)

NCT03861169 | Completed Results FDA Device

• 1 other identifier: 06213
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 15

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).

Conditions

Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• Change in Mean Unmedicated Diurnal IOP

  Change 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 Outcomes (2)

• Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP

  12 months

• Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months

  12 months

Study Arms (1)

Viscoeleastic delivery & trabeculotomy

EXPERIMENTAL

Patients with open angle glaucoma and cataract

Device: Transluminal viscoelastic delivery and trabeculotomy

Interventions

Transluminal viscoelastic delivery and trabeculotomy DEVICE

Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

Viscoeleastic delivery & trabeculotomy

Eligibility Criteria

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

You may qualify if:

• Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied 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) as documented in subjects' medical record per ICD-10 guidelines
• 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
• At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP
• Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
• Shaffer grade of ≥ 3 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.
• Understood and signed the informed consent

You may not qualify if:

• All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.
• 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
• Normal tension glaucoma
• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
• Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines
• Use of oral hypotensive medication treatment for glaucoma
• 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
• 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

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (15)

Eye Center South

Dothan, Alabama, 36301, United States

Location

Barnet Delaney Perkins Eye Center

Lake Havasu City, Arizona, 86403, United States

Location

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Your Eye Specialists

Weston, Florida, 33326, United States

Location

Omni Eye Services

Atlanta, Georgia, 30342, United States

Location

Eye Physicians and Surgeons, LLP

Iowa City, Iowa, 52245, United States

Location

Grene Vision Group

Wichita, Kansas, 62708, United States

Location

Vance Thompson Vision - MT

Bozeman, Montana, 59718, United States

Location

Vance Thompson Vision - NE

Omaha, Nebraska, 68154, United States

Location

Vance Thompson Vision - ND

West Fargo, North Dakota, 58708, United States

Location

Oklahoma Eye Surgeons

Oklahoma City, Oklahoma, 73104, United States

Location

Northern Ophthalmics

Jenkintown, Pennsylvania, 19406, United States

Location

El Paso Eye Surgeons

El Paso, Texas, 79902, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

Eye Centers of Racine and Kenosha

Kenosha, Wisconsin, 53142, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Tommie Rodriguez, Senior Clinical Research Manager
• Organization: Sight Sciences

trodriguez@sightsciences.com

818-687-3310

Study Officials

• Jaime Dickerson, PhD

  Sight Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: February 25, 2019
• First Posted: March 4, 2019
• Study Start: March 11, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)