Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification

Abstract

Introduction: This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Methods: This prospective interventional single-arm clinical trial enrolled 47 eyes with mildto-moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP). Results: Mean OSDI scores improved from 40.1 ± 21.6 (severe) preoperatively to 17.5 ± 15.3 (mild) at 3 months (p \ 0.0001). While 73% of eyes had moderate or severe OSDI scores preoperatively, 29% had such scores at 3 months, and the OSDI score was normal in 57% of eyes versus 9% preoperatively. Mean FTBUT increased from 4.3 ± 2.4 s preoperatively to 6.4 ± 2.5 s at 3 months (p \ 0.0001); mean Oxford corneal/conjunctival staining reduced from 1.4 ± 1.0 preoperatively to 0.4 ± 0.6 at 3 months (p \ 0.0001); mean Efron conjunctival hyperemia score reduced from 1.4 ± 0.7 preoperatively to 1.2 ± 0.6 at 3 months (p = 0.118). The number of glaucoma medications decreased from 1.5 ± 0.9 to 0.6 ± 0.8 mean medications (60% reduction, p \ 0.0001), with all eyes maintaining or reducing medications versus preoperatively and 55% of eyes becoming medication-free (versus 0% preoperatively). Mean IOP reduced from 17.4 ± 4.2 mmHg to 14.5 ± 3.2 mmHg (p \ 0.0001). The safety profile was excellent. Conclusion: Implantation of trabecular microbypass stent(s) (iStent or iStent inject) with cataract surgery produced significant improvements in ocular surface health, alongside significant reductions in IOP and medications. Trial registration: ClinicalTrials.gov identifier, NCT04452279.

Two-Year Comparative Outcomes of First- and Second-Generation Trabecular Micro-Bypass Stents with Cataract Surgery

“…The impact of MIGS surgery on OSD and QoL is an increasingly important area of research. To date, one study has specifically examined the change in OSD, 31 and one pivotal trial has analyzed the change in QoL, 37 following MIGS surgery and its attendant medication reductions; both studies were completed in eyes undergoing iStent or iStent inject implantation. The OSD analysis by Schweitzer et al showed significant improvements in objective examination findings and subjective symptom questionnaires following iStent or iStent inject implantation.…”

“…The OSD analysis by Schweitzer et al showed significant improvements in objective examination findings and subjective symptom questionnaires following iStent or iStent inject implantation. 31 The first QoL analysis within a MIGS pivotal trial, completed within the iStent inject trial, showed significantly higher rates of QoL and OSD improvement in stent eyes than in control eyes. 37 In light of the findings of these two studies, the substantial medication reduction observed in the present study is particularly important and relevant.…”

Treatment Success Across Different Levels of Preoperative Disease Burden: Stratified Two-Year Outcomes from the Pivotal Trial of iStent inject® Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract

“…Patients underwent surgery from January 2012 to August 2015. Postoperatively, study visits occurred at 6 hours, Day 1, Week 1, and at Months 1,3,6,11,12,18,23,and 24. Prior to the preoperative baseline visit, and at the Month 11 and Month 23 postoperative visits, subjects using ocular hypotensive medication(s) were instructed to undergo medication washout in order to permit unmedicated DIOP assessment at baseline and at Months 12 and 24, respectively.…”

“…With up to 7 years of postoperative follow-up, iStent studies have often focused on patients with mild to moderate POAG undergoing cataract surgery, but an increasing number of studies have assessed iStent for different glaucoma types (eg, pseudoexfoliative, angle-closure, pigmentary), more advanced severity, standalone cases, and in combination with other procedures or stents. [11][12][13][14][15][16][17][18][19][20][21][22][23] The more recent iStent inject ® Trabecular Micro-Bypass (CE Mark 2010, FDA approval 2018) contains two stents that create two patent bypasses through the diseased trabecular meshwork. This device has been studied both with and without concomitant cataract extraction, and in studies with up to 5 years of follow-up.…”

Standalone Implantation of 2–3 Trabecular Micro-Bypass Stents (iStent inject ± iStent) as an Alternative to Trabeculectomy for Moderate-to-Severe Glaucoma

“…These include studies in combined or standalone usage, single or multiple-stent placement, different racial groups, various glaucoma subtypes (e.g., pseudoexfoliative, pigmentary, narrow-angle, normal-tension), and different glaucoma severities (from ocular hypertensive to severe) . The literature also includes studies on the cost-effectiveness, cost-utility, and QoL benefits of iStent and iStent inject [39][40][41][42][43][44][45][46]. And recently, a number of wholly independent, investigator-initiated studies showed superior efficacy and safety with iStent or iStent inject than with other MIGS devices [47][48][49][50][51].…”