ABSTRACT
PURPOSE: Clinical evaluation and cost analysis of mitomycin-C-augmented PreserFlo MicroShunt versus trabeculectomy. DESIGN: Retrospective cohort study across 3 teaching hospitals. PARTICIPANTS: A total of 134 consecutive eyes of 129 patients (70 undergoing MicroShunt, 64 trabeculectomy). METHODS: Primary and secondary glaucoma cases with uncontrolled intraocular pressure (IOP) were included. Neovascular glaucoma and surgery combined with cataract extraction were excluded. The cost analysis used results from the clinical study to estimate operative costs (equipment and staff costs) and postoperative costs (follow-up visits, nonglaucoma medications, and postoperative procedures) per eye for PreserFlo and trabeculectomy. MAIN OUTCOME MEASURES: The primary clinical outcome measure was surgical failure (defined as IOP > 21 mmHg or < 20% reduction from baseline, IOP ≤ 5 mmHg, reoperation, or loss of light perception) or qualified and complete success (with or without medication) at 18 months. Secondary measures were IOP, glaucoma medications, visual acuity, mean deviation, time to cessation of steroid drops, complications, surgical time, follow-up visits, postoperative interventions, and reoperations. The cost analysis evaluated costs of PreserFlo compared with trabeculectomy. RESULTS: Baseline characteristics were similar, except for more non-White patients in the trabeculectomy group (51% Black and Asian vs. 32% MicroShunt, P = 0.02) and more cases with prior ab externo glaucoma surgery in the MicroShunt group (19% vs. 3% in the trabeculectomy group, P = 0.004). Overall, 59% of eyes had primary open-angle glaucoma. Mean follow-up was 19.9 months for both groups. At 18 months, surgical failure was 25% for MicroShunt compared with 35% for trabeculectomy (P = 0.18). Failure in MicroShunt cases was due to inadequate IOP reduction (84%) or reoperation for glaucoma (16%). Failure in trabeculectomy cases was due to inadequate IOP reduction (58%), persistent hypotony (29%), or reoperation for glaucoma (13%). Combined blebitis and endophthalmitis rate was 1.4% for MicroShunt and 3.1% for trabeculectomy. Cost analysis showed a savings of £245 to £566 per eye in the MicroShunt group, driven mostly by reduced postoperative procedures and follow-up visits. This is in contrast to prior randomized controlled trial data reporting the incremental cost of $2058 of PreserFlo over trabeculectomy. CONCLUSIONS: Our experience of introducing PreserFlo MicroShunt surgery showed it was safer than trabeculectomy and is a cost-saving and effective option that offers potential to free up highly limited National Health Service resources. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
ABSTRACT
PURPOSE: To report the response of participants switching from ranibizumab to aflibercept treatment for neovascular age-related macular degeneration (nAMD) requiring further anti-vascular endothelial growth factor treatment. METHODS: In this retrospective case review of 68 participants treated in a single hospital, all participants, prior to switching, received ranibizumab injections only. Best-corrected visual acuity (BCVA), clinical examination, and optical coherence tomography (OCT) were performed at each visit. Active nAMD was defined as persistent intraretinal or subretinal fluid on OCT. Participants had their first aflibercept injection at baseline and 2 more injections at 2 monthly intervals. Afterwards, they were followed up every 6-8 weeks and given injections as needed. The main outcome measures were visual acuity and the OCT central retinal thickness (CRT), average thickness (AT), and total macular volume (TMV). RESULTS: The BCVA at baseline visit was 0.57 ± 0.33 log MAR and the final BCVA was 0.54 ± 0.37 log MAR (p = 0.215). The CRT mean change was -75.6 ± 85.6 (p = 0.001), the AT mean change was -24.2 ± 27.2 (p = 0.001), and TMV mean change was -0.69 ± 0.78 (p = 0.001). There were no significant ophthalmic complications related to treatments. CONCLUSIONS: Intravitreal aflibercept improved anatomic outcomes (as measured by OCT) in eyes with nAMD that were previously treated with intravitreal ranibizumab and were still active. There was no statistically significant difference in logMAR visual acuity in participants who switched to aflibercept with a follow-up of at least 6 months.
