Assil Eye Institute is now enrolling patients in a multicenter, prospective post-market study utilizing the OMNI 2.0 (OMNI NextGen) Surgical System by Sight Sciences.
This device is used in the management of glaucoma by aiding in lowering intraocular pressure. Specifically, for this study, individuals need to have a diagnosis of mild to moderate open angle glaucoma and have already had uncomplicated cataract surgery with implantation of a posterior chamber intraocular lens (IOL).
Eligible patients enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. We are expecting and will be measuring for a decrease in unmedicated mean diurnal IOP (DIOP) and a change in the number of ocular hypotensive medications at the between screening and 12-month postoperative visit.
What is exciting about this device is that it allows for two procedures to be performed (delivery of viscoelastic fluid and customized trabeculectomy) with one MIGS (minimally invasive glaucoma surgery) device. The expansion of numerous MIGS surgeries over the past 10 years has had a profound impact on the treatment of glaucoma by improving the quality of life and visual outcomes. Given that Glaucoma is a lifelong condition that is managed rather than “cured” my patients benefit from me being able to offer a full range of treatment options.
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 the Baseline visit
- iStent or iStent Inject implanted ≤6 months prior to the Baseline visit
- Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to the 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 the use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.)
- In the Investigator’s judgment, 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
More information can be found at the NIH website clinicaltrials.gov
