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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 mild-to-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 micro-bypass 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.

SUBMITTER: Schweitzer JA

PROVIDER: S-EPMC7708605 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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

Schweitzer Justin A JA Hauser Whitney H WH Ibach Mitch M Baartman Brandon B Gollamudi Subba R SR Crothers Andrew W AW Linn John E JE Berdahl John P JP

Ophthalmology and therapy 20200813 4

<h4>Introduction</h4>This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject).<h4>Methods</h4>This prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-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 p ...[more]

PMID: 32789800

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Project description:PurposeThe study aimed to compare the 12-month post-operative outcomes of iStent and iStent inject W (inject W), and the factors associated with their success in open-angle glaucoma.MethodsThis single-center, retrospective comparative case series evaluated the medical records of patients who underwent iStent (comprising 1 stent) or inject W (comprising 2 stents) implantation with cataract surgery for primary open-angle glaucoma and normal tension glaucoma between January 2019 and March 2022. The 12-month post-operative efficacy outcomes included intraocular pressure (IOP), glaucoma medications, and survival analysis of the probability of success. "Failure" was defined as any of the following conditions compared to baseline: 1) IOP elevation, 2) increased glaucoma medication, or 3) IOP decline not exceeding 20% when glaucoma medication scores were comparable, and 4) need for additional glaucoma surgery. The safety outcomes included intra- and post-operative adverse events and changes in the best-corrected visual acuity and visual field.ResultsThe study comprised 55 eyes in the iStent and 105 in the inject W groups. At 12 months, treatment success was achieved in 66.0% of iStent and 78.4% of inject W eyes. The mean IOP was lower, and the percent reduction from baseline was equal in iStent-treated eyes (8.0% reduction, 14.8 mmHg to 13.7 mmHg, P<0.01) and inject W-treated eyes (11.9% reduction, 15.0 mmHg to 13.8 mmHg, P<0.01) (between-group comparison, P = 0.23). The mean medication burden decreased significantly from 2.5 to 1.1 for iStent (55.0% reduction, P<0.01) and 2.9 to 1.7 for iStent inject (46.8% reduction, P<0.01), with no significant differences between the two groups (P = 0.17). Both devices exhibited excellent safety.ConclusionsBoth devices significantly reduced IOP and glaucoma medication 12 months post-operatively. The outcome measures did not differ significantly between the two groups, and lower baseline IOP was predictive of surgical failure.

Project description:PURPOSE:To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract. METHODS:This was a retrospective analysis of 315 eyes from 230 adults with mild or moderate glaucoma treated with one or more intraocular pressure (IOP)-lowering medications (190 eyes of 134 subjects in the phaco-KDB group and 125 eyes of 96 subjects in the phaco-iStent group) that required no subsequent surgical intervention for IOP control through 12 months of follow-up. Data included best-corrected visual acuity (BCVA), IOP, and IOP-lowering medications, collected preoperatively and at 1 week and 1, 3, 6, and 12 months postoperatively as well as intraoperative and postoperative adverse events. The primary efficacy outcomes were the proportion of subjects in each group achieving ≥ 20% IOP reduction and ≥ 1 medication reduction at month 12. Subgroup analysis by baseline IOP (≤ 18 mmHg vs. > 18 mmHg) was also performed. RESULTS:Mean (standard error) baseline IOP was 18.2 (0.3) mmHg in the phaco-KDB group and 16.7 (0.3) mmHg in the phaco-iStent group (p = 0.001). Statistically significant mean IOP and mean IOP medication reductions from baseline were achieved at all time points in both groups. Mean IOP reductions were significantly greater in the phaco-KDB group than in the phaco-iStent group at all time points including month 12 [- 5.0 (0.3) mmHg vs. - 2.3 (0.4) mmHg, p < 0.001], while mean medication reductions were similar between groups at all time points except week 1, when greater mean medication reduction was seen in the phaco-iStent group (- 1.23 vs. - 0.60 medications, p < 0.001). At month 12, IOP reductions ≥ 20% were achieved by 64.2% and 41.6% (p < 0.001) in the phaco-KDB and phaco-iStent groups, respectively, and IOP medication reductions of ≥ 1 medication were achieved by 80.4% and 77.4% (p = 0.522), respectively. Intraocular pressure subgroup analysis revealed significant reductions in IOP-lowering medications without compromise of IOP control in lower IOP subgroups and significant reductions in both IOP and IOP-lowering medications in the higher IOP subgroups. The most common adverse events were transient IOP elevations and transient anterior chamber inflammation, which occurred with similar frequency in both groups and resolved spontaneously. CONCLUSION:Goniotomy with the KDB lowered IOP significantly more than iStent implantation, with few adverse events in both groups. In eyes with mild to moderate glaucoma undergoing combined cataract extraction and glaucoma surgery, goniotomy with the KDB can safely deliver statistically significant and clinically meaningful reductions in both IOP and IOP medication burden through 12 months of follow-up. FUNDING:New World Medical, Inc., provided funding for the study, medical writing assistance, Rapid Service Fees, and the open access fee.

Project description: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.

Project description:INTRODUCTION:This study evaluates long-term outcomes of two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin in eyes with refractory open angle glaucoma (OAG). METHODS:Prospective ongoing 5-year study of 80 eligible subjects (70 with 4-year follow-up) with OAG and IOP ≥ 18 mmHg after prior trabeculectomy and while taking 1-3 glaucoma medications. Subjects received two iStent® trabecular micro-bypass stents, one iStent Supra® suprachoroidal stent, and postoperative travoprost. Postoperative IOP was measured with medication and annually following medication washouts. Performance was measured by the proportion of eyes with ≥ 20% IOP reduction on one medication (the protocol-specified prostaglandin) versus preoperative medicated IOP (primary outcome); and the proportion of eyes with postoperative IOP ≤ 15 and ≤ 18 mmHg on one medication (secondary outcome). Additional clinical and safety data included medications, visual field, pachymetry, gonioscopy, adverse events, visual acuity, and slit-lamp and fundus examinations. RESULTS:Preoperatively, mean medicated IOP was 22.0 ± 3.1 mmHg on 1.2 ± 0.4 medications, and mean unmedicated IOP was 26.4 ± 2.4 mmHg. Postoperatively, among eyes without later cataract surgery, mean medicated IOP at all visits through 48 months was ≤ 13.7 mmHg (≥ 37% reduction), and annual unmedicated IOP was ≤ 18.4 mmHg (reductions of ≥ 30% vs. preoperative unmedicated IOP and ≥ 16% vs. preoperative medicated IOP). At all postoperative visits among eyes without additional surgery or medication, ≥ 91% of eyes had ≥ 20% IOP reduction on one medication versus preoperative medicated IOP. At month 48, 97 and 98% of eyes achieved IOP ≤ 15 and ≤ 18 mmHg, respectively, on one medication. Six eyes required additional medication, no eyes required additional glaucoma surgery, and safety measurements were favorable throughout follow-up. CONCLUSION:IOP control was achieved safely with two trabecular micro-bypass stents, one suprachoroidal stent, and postoperative prostaglandin. This microinvasive, ab interno approach introduces a possible new treatment option for refractory disease. TRIAL REGISTRATION:NCT01456390. FUNDING:Glaukos Corporation.

Dataset Information

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

Publications

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

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