Abstract
Purpose :
To evaluate the preliminary safety and efficacy of the InnFocus MicroShunt (IMS) for the surgical treatment of Primary Open Angle Glaucoma (POAG).
Methods :
Retrospective case-note review of all patients with a diagnosis of POAG who underwent IMS insertion augmented with mitomycin-C at Moorfields Eye Hospital between January 2016 and November 2018. Intraocular Pressure (IOP) and the number of topical IOP-lowering medications were noted at baseline, and at 3,6,12 & 18 months after surgery. The details of any early (≤1 month post-surgery) or late (≥3 month post-surgery) complications during follow-up were recorded.
Results :
34 eyes from 29 patients underwent IMS insertion during the study period. The mean duration of follow up was 11.9±10.3 months. The baseline IOP (mean±SD) was 22.0±6.9mmHg, and reduced to 14.1±5.6mmHg (36.1% reduction from baseline), 13.4±3.5 mmHg (39.2% reduction from baseline), 14.1±3.3mmHg (36.2% reduction from baseline), 14.0±3.1mmHg (36.5% reduction from baseline) at months 3,6,12 &18 respectively (all p values <0.01). The number of topical IOP-lowering medications (mean±SD) at baseline was 3.1±0.8, and reduced to 0.2±0.7, 0.2±0.6, 0.3±0.7 & 0.4±0.8 at months 3,6,12 &18 respectively (all p values <0.01). Transient early complications (≤1 month post-surgery) included hyphema (3/34 eyes, 8.8%), hypotony with choroidal effusion (3/34 eyes, 8.8%), diplopia (1/34 eyes, 2.9%). There was no occurrence of late hypotony, bleb leak, bleb-related infection, ptosis or significant visual loss. Three out of 34 eyes underwent cataract surgery during the follow up period. Bleb needling +/- sub-conjunctival 5-fluorouracil or steroid injection was performed in 2/34 (5.9%), 1/34 (2.9%), 1/34 (2.9%) eyes at month 1, 3 & 18, respectively. 2/34 (5.9%) eyes required surgical revision at month 3.
Conclusions :
IMS insertion augmented with mitomycin-C shows good preliminary efficacy with a favourable safety profile for the surgical treatment of POAG. Future reporting of randomized controlled clinical trials will provide a head-to head comparison of this new intervention to the current gold standard of trabeculectomy.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.