Clinical trial NCT04616573: A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma
Official title: A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 1
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.

Detailed description: First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 22 years or older
* Visually significant cataract
* Mild to moderate open angle glaucoma
* On 1-5 IOP-lowering medications
* 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.
* Understand and sign the informed consent.

Exclusion Criteria:

* Any of the following prior treatments for glaucoma:

  * Laser trabeculoplasty ≤3 months prior to baseline
  * Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
  * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
* Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
* 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).
* 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.

Primary outcomes:
measure: Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
timeFrame: 1 week
Secondary outcomes:
measure: Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline
timeFrame: 1 week
measure: Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive
timeFrame: 1 week
measure: Change in the Number of Ocular Hypotensive Medications Compared to Screening
timeFrame: 1 week
measure: Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline
timeFrame: 1 week
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Vineland
country: United States
facility: Eye Associates and SurgiCenter of Vineland
state: New Jersey
Study officials:
affiliation: Sight Sciences, Inc.
name: Kavita Dhamdhere, MD, PhD
role: STUDY_CHAIR
References: