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

  • STATUS
    Recruiting
  • End date
    May 24, 2022
  • participants needed
    110
  • sponsor
    Sight Sciences, Inc.
Updated on 24 January 2021
cataract
visual field tests
brimonidine tartrate ophthalmic solution
intraocular pressure
ocular hypotensive
hypotensive
primary open angle glaucoma
trabeculotomy

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).

Details
Condition Pigmentary glaucoma, Open Angle Glaucoma
Treatment OMNI® Surgical System
Clinical Study IdentifierNCT04465630
SponsorSight Sciences, Inc.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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