Glaucoma

Combined OMNI, Cataract Surgery Reduces IOP in Patients of Hispanic Ethnicity

Adrienne Taron
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Trabeculectomy
Trabeculectomy. Close-up of suturing the eye of a patient after a trabeculectomy, an operation to reduce pressure in the eye caused by glaucoma. The eye is held open by a metal retractor and a needle & forceps are seen stitching the thread. Glaucoma is caused by fluid build up in the eyeball. A trabeculectomy creates an alternative outlet for this fluid, thus reducing pressure. The mucous membrane covering the front of the eyeball (the conjunctiva) is opened and a half thickness of the white of the eye (the sclera) is cut and folded forward. A connection is made into the front chamber of the eye to act as a fluid outlet. The flap is sutured shut & conjunctiva replaced.
The dual procedure also cut the need for medication to help manage glaucoma, a report shows.

An implant-free, minimally-invasive glaucoma surgery (MIGS) procedure can help reduce intraocular pressure (IOP) and the need for antiglaucoma medications in patients with primary open-angle glaucoma (POAG) who are of Hispanic ethnicity, a report published in Clinical Ophthalmology shows. The study reviewed the safety and effectiveness of the OMNI® Surgical System — an approach that follows canaloplasty with trabeculotomy — when combined with cataract surgery in this class of patients. 

Patients of Hispanic heritage have particular unmet needs regarding POAG. Researchers say those patients — the second fastest growing, and second largest, ethnic demographic in the United States, is “underserved medically, as evidenced by the large estimated proportion of undiagnosed glaucoma,” researchers explain. “The prevalence of [POAG] in Hispanics is greater than for nonHispanic Whites.”

Research consisted of a case series of patients undergoing the OMNI procedure in conjunction with cataract surgery in a single-center, single surgeon data set. Researchers looked at 39 participants (mean age 69.2 years, 51% women) who were followed for 12 months. The age and sex demographics mirrored that of the 2019 GEMINI trial (ClinicalTrials.gov Identifier: NCT03861169) into the OMNI Surgical System (which included 220 patients of various ethnicities, 68.3 years, 60% women). Nearly all (39/41, 95%) subjects self-reporting as Hispanic in the GEMINI study are included in this analysis

Eligible patients underwent medication washout preoperatively and at month 12. Diurnal IOP (DIOP; 9 AM, 12 PM, 4 PM) was measured preoperatively and at 12 months — all with Goldmann tonometer. Following phacoemulsification cataract surgery through a clear corneal incision (CCI, ≤ 2 mm), canaloplasty and trabeculotomy (360/180 degree) was performed using the same CCI for access. No IOP-lowering medications were administered to patients after the surgery unless medically warranted. 

Medications were reduced to 0.15±0.43 (-93%, P <.001) with the majority (87%) of patients requiring no medications. There were no secondary surgical interventions (SSI) and adverse events (AE) were mild, self-limiting and typical of MIGS combined with cataract surgery, according to the investigators. They included 2 cases (5.1%) of IOP increases of 10 mm Hg or more at 1 month or longer, 3 cases (7.6%) of mild inflammation, and 1 case (2.6%) of hyphema 1 mm or more. 

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Prior to washout, the mean IOP was 16.5±2.8 mm Hg on an average of 2.0±1.1 medications, while the unmedicated mean diurnal IOP was 22.8±2.5 mm Hg preoperatively and 14.9±3.6 mm Hg at 12 months, (-7.9 mm Hg, -35%, P <.001). Most participants (38 out of 39, 97%) had an IOP reduction, and 85% had at least a 20% reduction.

The magnitude of these reductions was similar for those in the GEMINI trial, where IOP was reduced 8.2 mm Hg (-35%), and medication use by 1.4 (-80%). 

Study limitations include the relatively small sample size, the single-center, single surgeon nature, and the length of time. 

As the prevalence of POAG is greater among patients who are Hispanics than individuals who are non-Hispanic White, researchers point out that, “the size and potentially unique characteristics of this population underscore the importance of differentiated interventions and focused studies of effectiveness and safety in this ethnic group.” 

Disclosure: Some study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Gallardo MJ, Dhamdhere K, Dickerson Jr JE. Canaloplasty and trabeculotomy AB Interno combined with cataract surgery: 12-month outcomes in Hispanic patients with open-angle glaucoma. Clin Ophthalmol. 2022;16(3):905-908. doi:10.2147/opth.s358878

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