To compare phacoemulsification alone and phacoemulsification with micro-bypass stent implantation in eyes with primary open-angle glaucoma.
Instituto di Fisiopatologia Clinica, Clinica Oculistica, ...Universita' di Torino, Torino, Italy.
In this prospective double-masked randomized clinical trial, patients had phacoemulsification alone (control group) or phacoemulsification with iStent implantation (combined group). Primary outcomes were intraocular pressure (IOP) and reduction in medication use over 15 months and IOP after a 1-month washout of ocular hypotensive agents (ie, 16 months postoperatively).
The baseline IOP was similar between groups (combined group: 17.9 mm Hg +/- 2.6 SD; control group: 17.3 +/- 3.0 mm Hg) (P = .512). Three patients in the control group were lost to follow-up. The mean IOP was 14.8 +/- 1.2 mm Hg in the combined group and 15.7 +/- 1.1 mm Hg in the control group at 15 months and 16.6 +/- 3.1 mm Hg and 19.2 +/- 3.5 mm Hg, respectively, after washout; the IOP was statistically significantly lower in the combined group than in the control group at both time points (P = .031 and P = .042, respectively). At 15 months, the mean number of medications was lower in the combined group than in the control group (0.4 +/- 0.7 and 1.3 +/- 1.0, respectively; P = .007), as was the proportion of patients on ocular hypotensive medication (33% and 76%, respectively).
Phacoemulsification with stent implantation was more effective in controlling IOP than phacoemulsification alone; the safety profiles were similar.
To evaluate the efficacy and the safety of a new Schlemm canal scaffold microstent (Hydrus) combined with cataract surgery in routine clinical practice.
Clinics in Italy, Poland, and the United ...Kingdom.
Retrospective case series.
Clinical outcomes in patients with primary open-angle glaucoma who had combined phacoemulsification and microstent implantation were analyzed. Data (intraocular pressure IOP, number of glaucoma medications, incidence of complications) were collected preoperatively and postoperatively through 24 months.
Ninety-two eyes were included. Six patients had previous glaucoma surgeries. Sixty-seven patients completed a 2-year follow-up. The mean baseline IOP was 19.4 mm Hg ± 4.4 (SD). The mean IOP was 15.5 ± 2.7 mm Hg at 1 year and 15.7 ± 2.5 mm Hg at 2 years (P < .001). The IOP reduction was correlated with the baseline IOP (R
= 0.72). The mean number of glaucoma medications was 2.1 ± 1.0 preoperatively, decreasing significantly at 1 year (0.6 ± 1.0) and 2 years (0.7 ± 1.0) (P < .001). At 2 years, 64% of patients were medication free. In patients with an IOP of 18 mm Hg or higher preoperatively, the reduction in IOP and in the number of medications was higher. Two patients required microstent repositioning intraoperatively. One patient was treated with an argon laser for microstent obstruction, and 1 patient had a trabeculectomy at 18 months.
This microstent combined with cataract surgery safely and effectively reduced the IOP and medication use in a routine clinical practice setting with results comparable to those in previously published controlled clinical trials.
MIGS have been developed as a surgical alternative for glaucomatous patients.
To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, ...iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification.
Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280).
Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients' selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported.
Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.
To evaluate frequency, conversion rate, and risk factors for blindness in glaucoma patients treated in European Universities.
This multicenter retrospective study included 2402 consecutive patients ...with glaucoma in at least one eye. Medical charts were inspected and patients were divided into those blind and the remainder ('controls'). Blindness was defined as visual acuity≤0.05 and/or visual field loss to less than 10°.
Unilateral and bilateral blindness were respectively 11.0% and 1.6% at the beginning, and 15.5% and 3.6% at the end of the observation period (7.5±5.5 years, range:1-25 years); conversion to blindness (at least unilateral) was 1.1%/year. 134 eyes (97 patients) developed blindness by POAG during the study. At the first access to study centre, they had mean deviation (MD) of -17.1±8.3 dB and treated intraocular pressure (IOP) of 17.1±6.6 mmHg. During follow-up the IOP decreased by 14% in these eyes but MD deteriorated by 1.1±3.5 dB/year, which was 5-fold higher than controls (0.2±1.6 dB/year). In a multivariate model, the best predictors for blindness by glaucoma were initial MD (p<0.001), initial IOP (p<0.001), older age at the beginning of follow-up (p<0.001), whereas final IOP was found to be protective (p<0.05).
In this series of patients, blindness occurred in about 20%. Blindness by glaucoma had 2 characteristics: late diagnosis and/or late referral, and progression of the disease despite in most cases IOP was within the range of normality and target IOP was achieved; it could be predicted by high initial MD, high initial IOP, and old age.
How many aqueous humor outflow pathways are there? Costagliola, Ciro; dell’Omo, Roberto; Agnifili, Luca ...
Survey of ophthalmology,
March-April 2020, 2020 Mar - Apr, 2020-03-00, 20200301, Letnik:
65, Številka:
2
Journal Article
Recenzirano
The aqueous humor (AH) outflow pathways definition is still matter of intense debate. To date, the differentiation between conventional (trabecular meshwork) and unconventional (uveoscleral) pathways ...is widely accepted, distinguishing the different impact of the intraocular pressure on the AH outflow rate. Although the conventional route is recognized to host the main sites for intraocular pressure regulation, the unconventional pathway, with its great potential for AH resorption, seems to act as a sort of relief valve, especially when the trabecular resistance rises. Recent evidence demonstrates the presence of lymphatic channels in the eye and proposes that they may participate in the overall AH drainage and intraocular pressure regulation, in a presumably adaptive fashion. For this reason, the uveolymphatic route is increasingly thought to play an important role in the ocular hydrodynamic system physiology. As a result of the unconventional pathway characteristics, hydrodynamic disorders do not develop until the adaptive routes cannot successfully counterbalance the increased AH outflow resistance. When their adaptive mechanisms fail, glaucoma occurs. Our review deals with the standard and newly discovered AH outflow routes, with particular attention to the importance they may have in opening new therapeutic strategies in the treatment of ocular hypertension and glaucoma.
To investigate the efficacy and safety of a cross-linked gel stent (XEN45) with or without cataract surgery in the treatment of glaucoma patients.
Five university hospitals.
Prospective multicenter ...clinical trial.
Patients with glaucoma inadequately controlled by treatment or poor compliance or intolerance to topical therapy were included. Patients were divided into those who had an implant only (Solo Group; phakic and pseudophakic patients) and those who had an implant combined with cataract surgery (Combo Group). Differences in mean intraocular pressure (IOP) and number of medications between the baseline preoperative visit and study end (12 months), and the rate of qualified and complete success, were evaluated.
The Solo Group comprised 115 glaucoma patients (43 phakic and 72 pseudophakic) and the Combo Group comprised 56 patients. Compared with baseline, mean IOP (23.9 ± 7.6 to 15.5 ± 3.9) and number of medications (3.0 ± 1.1 to 0.5 ± 1.0) decreased significantly at 12-month follow-up (P < .001 for both). A >20% and >30% reduction in IOP from baseline was achieved by 72.3% and 52.6% of patients, respectively. IOP at 1 week postoperatively was a predictor of success, and the needling rate was inversely correlated with early postoperative IOP. The number of preoperative medications and patient age were not significantly associated with failure.
Insertion of a cross-linked gel stent alone or combined with phacoemulsification might be effective and safe in the treatment of open-angle glaucoma, with a substantial reduction in IOP and number of medications.
The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject (®) trabecular ...micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol.
Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject(®) devices in the treated eye and 98 to receive medical therapy.
At the month 12 visit, 94.7% of eyes (89/94) in the stent group reported an unmedicated intraocular pressure (IOP) reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98) in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02) at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94) in the iStent inject group and 89.8% of eyes (88/98) in the medical therapy group. Mean (standard deviation) IOP decreases from screening of 8.1 (2.6) mmHg and 7.3 (2.2) mmHg were reported in the iStent inject and medical therapy groups, respectively. A high safety profile was also noted in this study in both the iStent inject and medical therapy groups, as measured by stable best corrected visual acuity, cup-to-disc ratio, and adverse events.
These data show that the use of iStent inject is at least as effective as two medications, with the clinical benefit of reducing medication burden and assuring continuous treatment with full compliance to implant therapy as well as having a highly favorable safety profile.
The XEN Gel Microstent is a subconjunctival microinvasive glaucoma surgical device developed with the aim of improving the predictability and safety profile of bleb-forming glaucoma surgical ...procedures. The stent is a hydrophilic tube composed of a porcine gel cross-linked with glutaraldehyde with good stability and biocompatibility with minimal tissue reaction. This device has demonstrated promising outcomes with fewer risks compared to traditional surgeries. The aim of the review is to present early studies on different designs of the XEN Gel Stent, to summarize different surgical techniques of implantation and to analyze more comprehensively the results, complications and rates of needling of the commercially available device (Xen 45). The review will address separately special cases (PXG, UVG, ICE, congenital glaucoma) and describe small series and case reports.
To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG).
...Prospective, multicenter, randomized, single-masked, controlled clinical trial.
One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg.
On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Washout of hypotensive medications was repeated at 12 and 24 months.
Response to treatment was defined as a 20% or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline. Mean DIOP at 12 and 24 months, the proportion of subjects requiring medications at follow-up, and the mean number of medications were analyzed. Safety measures included change in visual acuity, slit-lamp observations, and adverse events.
The proportion of patients with a 20% reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group (80% vs. 46%; P = 0.0008). Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.9±3.3 mmHg vs. 19.2±4.7 mmHg; P = 0.0093), and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group (73% vs. 38%; P = 0.0008). There were no differences in follow-up visual acuity between groups. The only notable device-related adverse event was focal peripheral anterior synechiae (1-2 mm in length). Otherwise, adverse event frequency was similar in the 2 groups.
Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group, with no differences in safety.
To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a ...stand-alone procedure.
Meta-analysis.
At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss.
At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (−39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%.
This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.
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