OMNI in Standalone Pseudophakic Patients

Our practice is a tertiary eye care clinic that receives many referrals from local optometrists for glaucoma patients needing MIGS. For nearly 3 years, I have been recommending and managing procedures with the OMNI Surgical System (Sight Sciences). OMNI is a MIGS device that combines two implant-free procedures—canaloplasty and a trabeculotomy—effectively targeting all three points of potential resistance in the conventional outflow pathway, with or without cataract surgery. Leveraging MIGS and OMNI for pseudophakic glaucoma patients who are struggling with treatment compliance, medication side effects, or worsening glaucoma can be a big win.

Three Points of Resistance in the Conventional Outflow Pathway

OMNI works in the patient’s anatomical angle, improving aqueous outflow throughout the conventional pathway. There are several key benefits to this surgical approach. Most importantly, OMNI is currently the only angle-based MIGS procedure that targets all three potential points of outflow resistance—unroofing the trabecular meshwork (TM), dilating Schlemm’s canal, and enabling the movement of aqueous fluid through the collector channels. A standout factor that differentiates the device is OMNI’s procedural ability to more distally treat outflow at the level of the aqueous collector channels.

Postoperative Management for Referring ODs

The biggest question comanaging doctors should discuss is how and when to adjust preoperative glaucoma drops. My opinion is that a conservative approach is always safe and effective. I am cautious about taking patients off medications before the postsurgical steroid medication is completed. Depending on how the IOP responds to the treatment, I start to remove at least one drop at the 1-month mark, and I continue monitoring the pressure. As the pressure stabilizes, I consider the new baseline IOP to be 6 to 8 weeks postoperative. At that point, I can decide to remove further medications. I find that 3 to 6 months postoperative is an excellent time to get a new baseline structure and function ancillary measurements.

Another consideration with the OMNI (as with any MIGS procedure) is a postoperative IOP spike. With MIGS procedures focusing on outflow through the TM and Schlemm’s canal, two time-points will often differentiate the cause in the IOP spike. First, if the IOP spike is within the first 24 to 48 hours, this is most likely due to retained viscoelastic material, or heme clogging the outflow pathway. Burping the paracentesis to drain some of the fluid or adding a glaucoma drop will quell the glaucomatous risk. If the IOP spike appears 4 to 21 days postoperative, it would be an indication of a steroid response. In this case, we need to manage the steroid either by removing it entirely or adding a topical glaucoma medication.

In some instances, comanaging doctors may see slight blood reflux in the anterior chamber (patients on blood thinners are at a higher risk of surgically induced hyphema). However, it is important to note that this is almost always self-resolving and does not require a change in medication or further follow-up. Most patients don’t recognize it, but it can cause a few red blood cells in the anterior chamber, change in pigment, or cloudy vision. Setting appropriate expectations with patients and comanaging doctors for this possibility is important. I tell patients this is nothing to be concerned about, and it will go away over time on its own.

Outcomes with the OMNI

In our clinical experience, pseudophakic patients undergoing an OMNI combination procedure (canaloplasty and trabeculotomy) have an average IOP decrease of 5 mmHg to 6 mmHg and a reduction of one or two medications. With all glaucoma treatments, our goal is lowering IOP, and it is important to measure success based on the starting point of each patient. With the OMNI, going from 14 mmHg to 12 mmHg and reducing one medication in one patient may be an equal victory compared to a patient that went from 24 mmHg to 14 mmHg and reduced two medications. I also don’t expect patients to settle in the 8-mmHg to 11-mmHg range. Episcleral venous pressure (EVP), when healthy, is around 8 mmHg to 11 mmHg, and that should be the floor of IOP lowering for any OMNI patient.

Case for Pseudophakic OMNI

An 81-year-old patient complained of sore, red eyes and presented with moderate-to-severe glaucoma. He was taking two topical glaucoma drops—Lumigan (bimatoprost ophthalmic solution) 0.01% and Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% (both Allergan)—and was pseudophakic with an uncomplicated cataract surgery 5 years prior.

During his clinical exam, the patient presented with mild punctate keratitis on the cornea and a clear posterior chamber IOL with a clear capsule. His vertical cup to disc ratio was 0.65 mm in the right eye and 0.85 mm in the left eye. The patient’s GAT IOP was 26 mmHg in the right eye and 22 mmHg in the left eye. The patient also had a thin corneal pachymetry at 496 μm OD and 492 μm OS. Per his referring optometrist, his right eye visual field (VF) and optical coherence tomography (OCT) had been progressing, and escalation of therapy was needed (Figure 1).

After a thorough consideration of adding more medications, as well as discussing laser treatment versus pseudophakic MIGS, the patient opted for MIGS to decrease IOP, halt progression, and reduce his medication burden. He was especially motivated to reduce medications, so we chose to move forward with OMNI (canaloplasty and trabeculotomy).

The patient’s postoperative regimen involved an intracameral injection of antibiotic and steroid and a topical combination drop, which was prescribed for 1 month. We placed this patient on a standard postoperative follow-up schedule to monitor current glaucoma medications and make adjustments as needed. Here is what we observed and the decisions made to achieve our targeted goals:

• 1-day postoperative exam: With both glaucoma medications, the patient’s IOP measured 12 mmHg; Combigan was stopped.
• 1-week postoperative exam: The patient was on Lumigan, and his IOP measured 12 mmHg. The medication was continued.
• 1-month postoperative exam: The patient’s IOP measured 18 mmHg on Lumigan, and topical postoperative steroid was stopped.
• 3-month postoperative exam: The patient’s IOP had increased slightly to 21 mmHg. We debated adding a medication back but decided against it due to the patient’s non-compliance to drops.
• 6-month follow-up exam: The patient’s IOP measured 16 mmHg on Lumigan, demonstrating excellent stability in his right eye (Figure 2).

Currently, this patient is approaching the 1-year post-OMNI mark in his right eye. Most recently, his IOP was at 16 mmHg, and he has been able to stop two topical glaucoma agents after the OMNI procedure. The patient’s glaucoma has stabilized without further field progression, and his BCVA is at preoperative levels.

Conclusion

In our practice, we utilize OMNI confidently for patients with uncontrolled pseudophakic glaucoma, as it works exceptionally well for these patients. We lean on OMNI for its favorable safety profile and substantial long-term reductions in IOP and medicated eye drops. When thinking about OMNI for our pseudophakic patients, we rely on actual data, efficacious evidence, and our own successful experiences.

IMPORTANT PRODUCT INFORMATION

Indications for Use

The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Contraindications

Do not use the OMNI® in any situations where the iridocorneal angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter.

Do not use the OMNI® in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris.

Do not use the OMNI® Surgical System in quadrants with previous MIGS implants.

Please refer to the full Instructions For Use, available at omnisurgical.com, for warnings, precautions, and adverse event information.

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