Abstract
BackgroundThe short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up.MethodsThis longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events.ResultsA total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease.ConclusionsImplantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.
Highlights
The short- and medium-term outcomes of implantation of two first-generation trabecular micro-bypass stents (iStent) have been extensively studied; only few studies have investigated its long-term outcomes
Inclusion criteria consisted of glaucomatous damage evidenced by retinal nerve fiber layer (RNFL) imaging, ganglion cell analysis, or visual field testing; a coexisting cataract; the need for reduction of intraocular pressure (IOP) or glaucoma medications; and the availability of 8 years of follow-up data
Glaucoma severity was classified according to the Hodapp-Anderson-Parrish visual field criteria with visual field mean deviation (VFMD) no worse than −6 dB classified as mild, between −6 and −12 dB as moderate, and −12 dB or worse as severe glaucoma [54]
Summary
The short- and medium-term outcomes of iStent have been extensively studied; only few studies have investigated its long-term outcomes. Progressive optic neuropathy and a major cause of blindness worldwide [1]. The incidence of this degenerative condition is expected to rise with the increase in the aging population [2]. Patients benefit from different management approaches depending on their demographics, medication compliance, and disease type and severity. On the other extreme, advanced glaucoma cases are often managed via more invasive glaucoma surgeries, such as filtering surgeries. The efficacy of such procedures in reducing the IOP has been well established; there remain many concerns regarding the safety of these procedures [7,8,9]
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