To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG).
Prospective, multicenter, ...randomized clinical trial.
One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded.
Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively.
Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events.
Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines.
Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles.
To assess the effectiveness of topical ocular hypotensive medications in patients with open-angle glaucoma and to identify factors associated with postwashout intraocular pressure (IOP) elevation.
...Secondary analysis of prerandomization data from 2 prospective, multicenter, randomized clinical trials.
Fourteen hundred subjects (1,400 eyes, 781 from the HORIZON study of the Hydrus micro-stent and 619 from the COMPASS study of the Cypass micro-stent) with primary open-angle glaucoma who were using 0-4 classes of topical IOP-lowering medication underwent Goldmann applanation tonometry before and after a protocol-defined washout period.
The mean (standard deviation) age was 70.7 (8.0) years and 55.6% were female. The change in IOP following washout for patients using 0 (n = 100), 1 (n = 705), 2 (n = 355), 3 (n = 214), or 4 (n = 26) medications was 0.2 (2.8), 5.7 (3.3), 6.9 (3.7), 8.8 (5.0), and 9.5 (4.1) mm Hg, respectively (P < .001, Kruskal-Wallis test). Postwashout IOP change was similar between the HORIZON and COMPASS cohorts. No difference in postwashout IOP change was detected among individual prostaglandin analogues in patients on monotherapy. A generalized linear model identified the following factors to be associated with greater IOP rise upon medication washout: greater number of glaucoma medications, higher unmedicated IOP, thinner central corneal thickness (CCT), lack of prior selective laser trabeculoplasty (SLT), and male sex.
Cessation of glaucoma medications results in a dose-dependent IOP increase in treated open-angle glaucoma patients. Two independent clinical trial cohorts exhibit similar levels of IOP elevation upon washout, using standardized methodology to estimate real-world medication effectiveness. Thicker CCT and history of SLT may predict reduced response to IOP lowering medications.
To compare early postoperative intraocular pressure (IOP) in patients who underwent cataract surgery alone with those who underwent cataract surgery combined with implantation of a Hydrus Microstent ...(HMS) (Ivantis, Irvine, CA).
Subanalysis of data from the randomized controlled HORIZON trial, a multicenter trial including 26 US and 12 international sites.
Participants with mild/moderate primary open-angle glaucoma (POAG) and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications.
A total of 556 subjects were randomized in a 2:1 ratio to undergo cataract surgery with placement of the HMS versus cataract surgery alone (no microstent NMS). All eyes were washed out of IOP-lowering medications before surgery and remained unmedicated until surgery. No IOP-lowering prophylaxis was used postoperatively. Comprehensive eye examination including measurement of intraocular pressure was conducted on postoperative day (POD) 1, week 1, and month 1.
Postoperative IOP >40 mmHg was analyzed as the primary outcome. Incidence of IOP increase >10 mmHg above baseline, unmedicated IOP, and mean IOP were analyzed as secondary outcomes.
A total of 369 eyes were randomized to the HMS group, and 187 eyes were randomized to cataract surgery alone. The HMS and NMS groups did not differ with respect to baseline demographic or ocular characteristics. On POD1, the incidence of IOP spike >40 mmHg was significantly higher at 14.4% in the NMS group compared with 1.4% in the HMS group (P < 0.001). The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001). IOP in the NMS group was significantly higher than in the HMS group (27.6 vs. 17.0 mmHg, P < 0.001). In multivariable logistic regression analysis, higher baseline IOP predicted higher odds of POD1 IOP spike >40 mmHg, whereas the presence of HMS was associated with a lower likelihood of postoperative IOP spike.
The addition of an HMS at the time of cataract surgery lowered the risk of markedly elevated IOP in the early postoperative period in patients with glaucoma.
To determine rates of success and complications of trabeculectomy surgery.
Case series.
Consecutive patients undergoing trabeculectomy by 2 surgeons between May 2000 and October 2008.
By using the ...Wilmer Institute's billing database, we identified all patients at least 12 years of age coded as having undergone trabeculectomy between May 2000 and October 2008 by 1 of 2 glaucoma surgeons and whose surgery was not combined with another operation. From the chart, we abstracted demographic information on the patients and clinical characteristics of the eyes. The Kaplan-Meier product-limit method and Cox proportional hazard models were used to look at success rates and characteristics associated with inadequate intraocular pressure (IOP) reduction. Complications were tabulated.
(1) Success rate of trabeculectomy, as determined by the achievement of each of 4 different IOP goals, with or without IOP-lowering medications; and (2) incidence of surgical complications.
During the study period, 797 eyes of 634 persons underwent trabeculectomy without concurrent surgery. The success rates 4 years after surgery, with or without the use of IOP-lowering eye drops, were 70%, 72%, 60%, and 44%, for achievement of target IOP, ≤18 mmHg and ≥20% IOP reduction, ≤15 mmHg and ≥25% reduction, and ≤12 mmHg and ≥30% reduction, respectively. Increased chance of success was associated with European-derived race; use of mitomycin C (MMC); higher concentrations of MMC, when used; and higher preoperative IOP. Age and previous intraocular surgery were not associated with surgical success. Complications included worsening lens opacity in 242 of 443 phakic eyes (55%), loss of ≥3 lines of acuity (Snellen) in 161 eyes (21%), surgery for bleb-related problems in 70 eyes (8.8%), and infection occurring >6 weeks after surgery in 27 eyes (3.4%). A total of 101 eyes of 94 patients had at least 1 subsequent operation for inadequate IOP control.
Trabeculectomy surgery performed by 2 experienced glaucoma specialists achieved target IOP at 4 years in 70% of those operated and was associated with progressive cataract and small risks of bleb-related complications. These results are comparable to those reported in smaller series.
Glaucoma is an acquired degeneration of the optic nerve and a leading cause of blindness worldwide. Medical and surgical treatments that decrease intraocular pressure may prevent visual impairment ...and blindness.
To compare the effectiveness of medical, laser, and surgical treatments in adults with open-angle glaucoma with regard to decreasing intraocular pressure and preventing optic nerve damage, vision loss, and visual impairment.
MEDLINE, CENTRAL, and an existing database for systematic reviews (through 2 March 2011); MEDLINE, EMBASE, LILACS, and CENTRAL for primary studies (through 30 July 2012).
English-language systematic reviews; randomized, controlled trials; and quasi-randomized, controlled trials for most outcomes and observational studies for quality of life and harms.
Two investigators abstracted or checked information about study design, participants, and outcomes and assessed risk of bias and strength of evidence.
High-level evidence suggests that medical, laser, and surgical treatments decrease intraocular pressure and that medical treatment and trabeculectomy reduce the risk for optic nerve damage and visual field loss compared with no treatment. The direct effect of treatments on visual impairment and the comparative efficacy of different treatments are not clear. Harms of medical treatment are primarily local (ocular redness, irritation); surgical treatment carries a small risk for more serious complications.
Heterogeneous outcome definitions and measurements among the included studies; exclusion of many treatment studies that did not stratify results by glaucoma type.
Medical and surgical treatments for open-angle glaucoma lower intraocular pressure and reduce the risk for optic nerve damage over the short to medium term. Which treatments best prevent visual disability and improve patient-reported outcomes is unclear.
To compare cataract surgery with implantation of a Schlemm canal microstent with cataract surgery alone for the reduction of intraocular pressure (IOP) and medication use after 24 months.
...Prospective, multicenter, single-masked, randomized controlled trial.
Subjects with concomitant primary open-angle glaucoma (POAG), visually significant cataract, and washed-out modified diurnal IOP (MDIOP) between 22 and 34 mmHg.
Subjects were randomized 2:1 to receive a single Hydrus Microstent (Ivantis, Inc, Irvine, CA) in the Schlemm canal or no stent after uncomplicated phacoemulsification. Comprehensive eye examinations were conducted 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months postoperatively. Medication washout and MDIOP measurement were repeated at 12 and 24 months.
The primary and secondary effectiveness end points were the proportion of subjects demonstrating a 20% or greater reduction in unmedicated MDIOP and change in mean MDIOP from baseline at 24 months, respectively. Hypotensive medication use was tracked throughout the course of follow-up. Safety measures included the frequency of surgical complications and adverse events.
A total of 369 eyes were randomized after phacoemulsification to Hydrus Microstent (HMS) and 187 to no microstent (NMS). At 24 months, unmedicated MDIOP was reduced by ≥20% in 77.3% of HMS group eyes and in 57.8% of NMS group eyes (difference = 19.5%, 95% confidence interval CI 11.2%-27.8%, P < 0.001). The mean reduction in 24-month unmedicated MDIOP was -7.6±4.1 mmHg (mean ± standard deviation) in the HMS group and -5.3±3.9 mmHg in the NMS group (difference = -2.3 mmHg; 95% CI, -3.0 to -1.6; P < 0.001). The mean number of medications was reduced from 1.7±0.9 at baseline to 0.3±0.8 at 24 months in the HMS group and from 1.7±0.9 to 0.7±0.9 in the NMS group (difference = -0.4 medications; P < 0.001). There were no serious ocular adverse events related to the microstent, and no significant differences in safety parameters between the 2 groups.
This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone.
To compare the success and complications of trabeculectomy performed with limbus-based and fornix-based conjunctival approaches.
Retrospective case series with some prospective data collection.
...Consecutive patients undergoing trabeculectomy by 2 surgeons between May 2000 and October 2008.
We performed limbus-based operations during the first 4 years and fornix-based operations during the last 4 years. We collected data by chart review and by examination at the most recent visit. For each follow-up visit, we defined success as undergoing no further glaucoma procedure and achieving one of our intraocular pressure (IOP) criteria. We used Kaplan-Meier survival analysis, Cox proportional hazards models, and generalized estimating equation (GEE) analysis. During 2009, 439 trabeculectomy sites of 347 patients were quantitatively assessed by the Indiana bleb grading system.
(1) Success rate of trabeculectomy, as determined by the achievement of each of our different IOP goals, with or without IOP-lowering medications; and (2) incidence of surgical complications.
During the 4 years after surgery, the success rates of limbus-based and fornix-based trabeculectomy were not statistically different for any of our IOP criteria. Blebs after limbus-based surgery were more likely to be graded as higher and to be avascular (GEE model, both P < 0.0001). Four percent of eyes experienced late-onset bleb leaks within 4 years after both limbus- and fornix-based operations; however, limbus-based cases developed bleb leaks significantly later than did fornix-based cases (2.1 vs. 1.0 years; P=0.002, GEE model). Late bleb-associated infection during the first 4 years after surgery occurred more often in limbus-based operations, although statistical significance was borderline (P=0.054, Cox model). Symptomatic hypotony during all available follow-up was more common with fornix-based operations (P=0.01, GEE model). Eyes undergoing the fornix-based operation had a greater risk of cataract surgery in the 4-year period after surgery (P=0.02, Cox model), and fornix-based cases requiring cataract surgery had the operation earlier than limbus-based cases (P=0.002, GEE model).
Success rates are similar between limbus-based and fornix-based trabeculectomy. Limbus-based procedures produce higher, more avascular blebs, with a greater risk of infection. Fornix-based procedures have more symptomatic hypotony and more and earlier cataract development.
To review the published literature and summarize clinically relevant information about novel, or emerging, surgical techniques for the treatment of open-angle glaucoma and to describe the devices and ...procedures in proper context of the appropriate patient population, theoretic effects, advantages, and disadvantages.
Devices and procedures that have US Food and Drug Administration clearance or are currently in phase III clinical trials in the United States are included: the Fugo blade (Medisurg Ltd., Norristown, PA), Ex-PRESS mini glaucoma shunt (Alcon, Inc., Hunenberg, Switzerland), SOLX Gold Shunt (SOLX Ltd., Boston, MA), excimer laser trabeculotomy (AIDA, Glautec AG, Nurnberg, Germany), canaloplasty (iScience Interventional Corp., Menlo Park, CA), trabeculotomy by internal approach (Trabectome, NeoMedix, Inc., Tustin, CA), and trabecular micro-bypass stent (iStent, Glaukos Corporation, Laguna Hills, CA).
Literature searches of the PubMed and the Cochrane Library databases were conducted up to October 2009 with no date or language restrictions.
These searches retrieved 192 citations, of which 23 were deemed topically relevant and rated for quality of evidence by the panel methodologist. All studies but one, which was rated as level II evidence, were rated as level III evidence.
All of the devices studied showed a statistically significant reduction in intraocular pressure and, in some cases, glaucoma medication use. The success and failure definitions varied among studies, as did the calculated rates. Various types and rates of complications were reported depending on the surgical technique. On the basis of the review of the literature and mechanism of action, the authors also summarized theoretic advantages and disadvantages of each surgery.
The novel glaucoma surgeries studied all show some promise as alternative treatments to lower intraocular pressure in the treatment of open-angle glaucoma. It is not possible to conclude whether these novel procedures are superior, equal to, or inferior to surgery such as trabeculectomy or to one another. The studies provide the basis for future comparative or randomized trials of existing glaucoma surgical techniques and other novel procedures.
To estimate payments for glaucoma care among Medicare beneficiaries from 2002 to 2009.
Database study.
Data from a 5% random sample of Medicare billing information from 2002 to 2009.
Medicare ...beneficiaries, aged 65 years or older, with both Parts A and B fee-for-service (FFS) enrollment comprised the annual denominator. For each year, we included those with a defined glaucoma diagnostic code linked to a glaucoma visit, diagnostic test, or laser/surgical procedure. Open-angle, angle-closure, and other glaucoma were categorized separately. Claims were classified into glaucoma care, other eye care, and other medical care.
Cost of glaucoma care in the Medicare Fee-for-Service Population.
In 2009, total glaucoma payments by Medicare were $37.4 million for this subset, for an overall estimated cost of $748 million, or 0.4% of an estimated cost of $192 billion for all Medicare FFS payments. Office visits comprised approximately one half, diagnostic testing was approximately one-third, and surgical and laser procedures were approximately 10% of glaucoma-related costs. Coded open-angle glaucoma (OAG) and OAG suspects accounted for 87.5% of glaucoma costs, whereas cost per person was highest in "other glaucoma." In 2009, <3% of patients with OAG underwent incisional surgery and approximately 5% had laser trabeculoplasty. Laser iridotomy was the highest cost category among patients with angle-closure glaucoma, whereas office visits was the highest cost category among the "other glaucoma" group. The total cost of nonglaucoma eye care for patients with glaucoma was 67% higher than their glaucoma care costs; these were chiefly costs for cataract surgery and treatment of retinal diseases. From 2002 to 2009, FFS glaucoma care costs calculated in 2009 dollars were stable and cost per person per year in 2009 dollars decreased from $242 to $228 (P = 0.01 by test for linear trend).
Annual glaucoma care costs per person decreased in constant dollars from 2002 to 2009. Cataract and retinal eye care for patients with glaucoma substantially exceeded the cost of their glaucoma care each year. Visit payments represented the largest category of costs.
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