Purpose To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract. Setting Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Design Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg. Methods Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months. Results A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (−35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (−80%). At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6–18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure. Conclusion Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.

Purpose: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI ® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG). Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama,

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Purpose:The aim of this study was to demonstrate the safety and effectiveness of a single TearCare procedure compared with a single LipiFlow procedure in treatment of the dry eye disease associated with meibomian gland dysfunction.Methods:In a multicenter, masked, randomized controlled trial, 135 subjects received a single TearCare (TC) treatment (n = 67) or a single LipiFlow (LF) treatment (n = 68) at baseline and were followed up for 1 month posttreatment. Tear film breakup time, meibomian gland function, and corneal and conjunctival staining scores were assessed as dry eye signs at baseline, 2 weeks, and 1 month; dry eye symptoms were assessed using the Ocular Surface Disease Index, Symptom Assessment in Dry Eye, and eye dryness questionnaires at baseline and 1 month.Results:At 1 month posttreatment, both groups demonstrated significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score to 3.0 ± 4.4 and 11.2 ± 11.1 in the TC group and 2.6 ± 3.3 and 11.0 ± 10.4 in the LF group, respectively. The mean eye dryness, Symptom Assessment in Dry Eye, and Ocular Surface Disease Index scores were significantly reduced (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5 in the TC group and 34.9 ± 26.9, 38.0 ± 25.9, and 23.4 ± 17.7 in the LF group, respectively. There were no statistically significant differences for any result between the groups. However, the TC group demonstrated numerically greater improvements consistently in all signs and symptoms. Device-related ocular adverse events were reported in 3 patients in the TC group (superficial punctate keratitis, chalazion, and blepharitis) and 4 patients in the LF group (blepharitis, 2 cases of foreign body sensation, and severe eye dryness).Conclusions:A single TearCare treatment significantly alleviates the signs and symptoms of dry eye disease in patients with meibomian gland dysfunction and is equivalent in its safety and effectiveness profile to LipiFlow treatment as shown in this 1-month follow-up study.