To compare 2 frequently used aqueous shunts for the treatment of glaucoma.
International, multicenter, randomized trial.
Patients aged 18 years or older with uncontrolled glaucoma despite maximum ...tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy.
Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique.
The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions.
A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures.
Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group.
(1) To propose the use of episcleral venous outflow (EVO) as an outcome marker of iStent surgery, and an EVO grading scale. (2) To determine the association of EVO with: (a) postoperative intraocular ...pressure (IOP) and medication burden; (b) iStent patency status.
Retrospective cohort study including 151 glaucomatous eyes having undergone iStent-phacoemulsification surgery. Demographic and preoperative data (IOP, number of antiglaucoma medications, glaucoma type and stage, maximal IOP) were collected. Postoperatively, were recorded: IOP, number of antiglaucoma medications, occurrence of stent malpositioning or obstruction, and EVO scores based on the proposed scale (0: no laminar flow; 1+: faint laminar flow; 2+: marked laminar flow). A Kruskal-Wallis test determined the association between EVO, postoperative IOP, and medication burden. A multivariable-adjusted ordinal logistic regression was used for the association with iStent patency status.
Patients with marked laminar flow (2+) were more likely to have a lower IOP (P=0.022) and fewer medications (P=0.009) at 1-year postoperatively than those with no laminar flow (0). No difference was found in postoperative IOP and number of medications when comparing patients having faint laminar flow (1+) with patients from the other 2 EVO categories (0 and 2+). iStent patency was associated with greater EVO as opposed to its obstruction (odds ratio, 4.73; 95% confidence interval, 1.74-12.9). No malpositioned stents were noted in our cohort.
The use of EVO as an outcome marker of iStent surgery is physiologically plausible. The proposed EVO grading scale is simple, comprises few categories, and is easily applicable in an in-office setting. The results of this study suggest this scale could be useful in the assessment of iStent functionality and encourage its further investigation in prospective studies.
To examine the presentation and management of 3 cases of bleb-related infection following ab interno gel implant surgery, so as to add to the growing understanding of complications associated with ...the emerging landscape of newer, minimally invasive glaucoma surgical procedures, and how they are best managed.
Multicenter retrospective interventional case series.
Consecutive cases of bleb-related infection following ab interno gel implant surgery from 2 university-affiliated hospitals were included. Risk factors, visual outcomes, intraocular pressure, and subsequent management were analyzed.
We report 3 cases of late bleb-related infection occurring after ab interno gelatin stent insertion (8, 7, and 24 months after surgery). One case had blebitis only; the other 2 had bleb-related endophthalmitis. All cases responded rapidly to management of their infections according to standard bleb-related infection protocol, recovering to within 2 lines of their previous visual acuity (6/9, 6/12, and 6/18). Explantation of the devices was not required.
Bleb-related infections after ab interno gel implant insertion can occur. If infection is treated appropriately, good clinical outcomes are possible.
Purpose
To assess the 1-year efficacy and safety of the implantation of two second-generation trabecular micro-bypass stents (iStent Inject
®
) with concomitant cataract surgery in various subtypes ...and severities of glaucoma.
Methods
This single-surgeon, consecutive case series from a Canadian academic ophthalmology center included subjects with cataract, glaucoma, and the need to reduce intraocular pressure (IOP) and/or medications. The 12-month outcomes included mean IOP and medication burden as well as the proportions of eyes with IOP ≤ 18, ≤ 15, and ≤ 12 mmHg compared to baseline. Other measures included corrected distance visual acuity (CDVA), cup-to-disc ratio (CDR), visual field mean deviation (VF MD), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GCIPL) thickness, and adverse events.
Results
In 118 eyes, mean IOP reduced from 17.00 ± 3.82 mmHg preoperatively to 13.97 ± 2.65 mmHg at the 12-month follow-up mark (17.8% reduction,
p
< 0.001), and mean medication burden decreased from 2.31 ± 1.33 preoperatively to 1.03 ± 1.10 medications (56% reduction,
p
< 0.001). After 12 months, 93% of eyes achieved IOP ≤ 18 mmHg (versus 69% preoperatively), 70% of eyes achieved IOP ≤ 15 mmHg (versus 42% preoperatively), and 29% of eyes achieved IOP ≤ 12 mmHg (versus 7% preoperatively). For all eyes, topical medications were either maintained or decreased from baseline, with ≥ 1 medication eliminated from the preoperative regimen for 83% of eyes and ≥ 2 medications eliminated for 36% of eyes. Visual acuity improved significantly, consistent with expectations for cataract surgery, while CDR, VF MD, and RNFL and GCIPL thicknesses remained stable. Safety was favorable, with no intraoperative complications and few transient adverse events postoperatively.
Conclusion
iStent Inject implantation with cataract surgery safely reduced IOP and medication burden in a real-world clinical population with mild to severe glaucoma, and stabilized visual field, as well as RNFL and GCIPL thicknesses on OCT.
Funding
The Rapid Service Fees were funded by Glaukos Corporation.
Purpose
The efficacy and safety of the trabecular micro-bypass stents (iStent and iStent
inject
) have been well documented in various open-angle glaucoma subtypes. However, their outcomes remain ...understudied in normal-tension glaucoma (NTG). The present study aimed to assess the 1-year outcomes related to the implantation of two second-generation trabecular micro-bypass stents (iStent
inject
) concomitant with cataract surgery (CE-TMS), exclusively in eyes with NTG.
Methods
This multi-center, consecutive case series included eyes with cataract and normal-tension glaucoma that underwent CE-TMS to reduce intraocular pressure or glaucoma medication use. The 12-month efficacy measures included change in average intraocular pressure (IOP) and medication burden. Safety included change in best-corrected visual acuity, cup-to-disc ratio, visual field mean-deviation and retinal nerve fiber layer thickness. Intra- or postoperative adverse events were noted.
Results
A total of 62 eyes with mild-to-severe NTG and average preoperative IOP of 15.82 ± 2.94 mmHg on 1.50 ± 1.28 glaucoma medications were included. Postoperatively, IOP declined by 22% from 15.82 ± 2.94 mmHg to 12.32 ± 2.58 (
p
< 0.001), all eyes had IOP ≤ 18 mmHg (versus 74% preoperatively), and half had IOP ≤ 12 mmHg (versus 15% preoperatively). Medication burden decreased by 70% from 1.50 ± 1.28 to 0.45 ± 0.86 (
p
< 0.001), and 73% of the eyes were medication-free (versus 23% preoperatively). Safety was favorable, with no evidence of sight-threatening adverse events.
Conclusion
Implantation of iStent
inject
(two second-generation trabecular micro-bypass stents) combined with cataract surgery is efficacious in reducing IOP and medication burden with a favorable safety profile in eyes with mild-to-severe NTG.
Background The 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. Methods This 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. Results A total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 + or - 3.9 mmHg preoperatively to 14.2 + or - 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP less than or equai to 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP less than or equai to 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP less than or equai to 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 + or - 1.1 preoperatively to 2.3 + or - 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. Conclusions Implantation 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. Keywords: Minimally invasive glaucoma surgery, MIGS, Trabecular micro-bypass stent, iStent, Glaucoma, Cataract surgery, Long-term outcomes
To report the 1-year treatment outcomes of the Ahmed Versus Baerveldt (AVB) Study.
Multicenter randomized clinical trial.
A total of 238 patients were enrolled in the study, including 124 in the ...Ahmed group and 114 in the Baerveldt group.
Patients aged 18 years or older with uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA), to be followed for 5 years.
The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (5-18 mmHg with ≥ 20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions.
There were no significant differences in baseline ocular or demographic characteristics between the study groups with the exception of sex. Preoperatively, the study group had a mean IOP of 31.4 ± 10.8 mmHg on a mean of 3.1 ± 1.0 glaucoma medications with a median Snellen acuity of 20/100. The cumulative probability of failure a 1-year was 43% in the Ahmed group and 28% in the Baerveldt group (P = 0.02). The mean IOP at 1 year was 16.5 ± 5.3 mmHg in the Ahmed group and 13.6 ± 4.8 mmHg in the Baerveldt group (P < 0.001). The mean number of glaucoma medications required was 1.6 ± 1.3 in the Ahmed group and 1.2 ± 1.3 in the Baerveldt group (P = 0.03). Visual acuity was similar in both groups at all visits in the first year (P = 0.66). In the first year after surgery, there were a similar number of patients who experienced postoperative complications in the 2 groups (45% Ahmed, 54% Baerveldt, P = 0.19), but a greater number of patients in the Baerveldt group required interventions (26% Ahmed vs. 42% Baerveldt, P = 0.009).
The Baerveldt-350 group had a higher success rate than the Ahmed-FP7 group after 1 year of follow-up, but required a greater number of interventions.
Proprietary or commercial disclosure may be found after the references.
Estimate patient adherence to glaucoma medications and identify potential determinants of nonadherence.
Descriptive study.
Two hundred patients with open angle glaucoma, ocular hypertension, or ...glaucoma suspects were interviewed regarding their glaucoma and its treatment and their charts were reviewed. Their ophthalmologist completed a brief assessment form. Drug utilization data were extracted from the provincial drug program database. Patients were defined as adherent if they filled at least 75% of the prescribed medication necessary for their treatment.
Data were available for 181 patients. About 62.9% were female and the mean age (+/-SD) was 75.1+/-8.8 years. The mean number of years of glaucoma treatment was 10.7+/-9.3. Self-reported treatment adherence was 88.3%. On the basis of the drug database, the proportion of patients who were adherent to treatment was 71.8%. According to physicians, 74.6% of patients were adherent. Among patients considered by physicians as nonadherent, 71.1% (32/45) were adherent and among patients predicted as adherent, 72.1% (98/136) were adherent. There was no significant difference in adherence according to age, sex, education, and income. However, patients using fewer agents (P=0.041), who were widowed (P=0.041), or who lived alone (P=0.042) were more adherent. Patients using prostaglandins analogs or beta-blockers were more adherent than those using carbonic anhydrase inhibitors (P<0.05).
Fewer medications, use of prostaglandin analogs or beta-blockers, living alone, and being widowed were significantly associated with adherence. Physicians were unable to significantly predict which patients are adherent.
Glaucoma is a medical term describing a group of progressive optic neuropathies characterized by degeneration of retinal ganglion cells and retinal nerve fibre layer and resulting in changes in the ...optic nerve head. Glaucoma is a leading cause of irreversible vision loss worldwide. With the aging population it is expected that the prevalence of glaucoma will continue to increase. Despite recent advances in imaging and visual field testing techniques that allow establishment of earlier diagnosis and treatment initiation, significant numbers of glaucoma patients are undiagnosed and present late in the course of their disease. This can lead to irreversible vision loss, reduced quality of life, and a higher socioeconomic burden. Selection of therapeutic approaches for glaucoma should be based on careful ocular examination, patient medical history, presence of comorbidities, and awareness of concomitant systemic therapies. Therapy should also be individualized to patients’ needs and preferences. Recent developments in this therapeutic field require revisiting treatment algorithms and integration of traditional and novel approaches in order to ensure optimal visual outcomes. This article provides an overview of recent developments and practice trends in the medical management of glaucoma in Canada. A discussion of the surgical management is beyond the scope of this paper.
To mathematically model the conventional aqueous humor outflow system with trabecular meshwork (TM) bypass and Schlemm canal (SC) dilation.
The SC was modeled as a rectangular channel with the TM ...modeled as a permeable membrane. The collector channels (CCs) were modeled as fluid sinks distributed along the outer wall of SC. Two different implants were investigated in this study. The Hydrus Microstent (scaffold) was modeled with a TM bypass and a dilated region in SC that was 7 or 15 mm long and approximately 5-fold larger than the normal height of SC (h0). The iStent trabecular microbypass was modeled with a similar structure except that the dilated region in SC was 1 mm long and 25% larger than h0.
Creation of a TM bypass structure would increase the pressure in the surrounding regions inside the SC and make it close to the intraocular pressure. SC dilation would increase the pressure more uniformly in the dilated region. The pressure increase led to higher flow rates in SC and CCs, and subsequently increased outflow facility (C). If CCs were uniformly distributed, the increase in C was the smallest after implantation of 1 microbypass, compared with that after implantation of 2 microbypasses or 1 scaffold. If CCs were nonuniformly distributed, the magnitude of increase in C was sensitive to the location of implant, and the sensitivity was higher for the microbypass than the scaffold.
The study showed that creation of TM bypass and SC dilation significantly increased outflow facility, and the amount of increase correlated with the length of dilated regions in SC.
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