Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

Long-term Outcomes from the HORIZON Randomized Trial for a Schlemm's Canal Microstent in Combination Cataract and Glaucoma Surgery.

PURPOSE: To present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone. DESIGN: Prospective, multicenter, controlled randomized clinical trial. PARTICIPANTS: Patients with cataract and primary open-angle glaucoma treated with 1 or more glaucoma medications, washed-out diurnal intraocular pressure (DIOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: Eyes were randomized 2:1 to receive a Hydrus Microstent (HMS; Ivantis, Inc) or no stent after successful CS. MAIN OUTCOME MEASURES: Intraocular pressure (IOP), glaucoma medication use, repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only. Study groups were well matched for preoperative IOP, medication use, washed-out DIOP, and glaucoma severity. Five-year follow-up was completed in 80% of patients. At 5 years, the HMS group included a higher proportion of eyes with IOP of 18 mmHg or less without medications than the CS group (49.5% vs. 33.8%; P = 0.003), as well as a greater likelihood of IOP reduction of 20% or more without medications than the CS group (54.2% vs. 32.8%; P < 0.001). The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001). The cumulative risk of incisional glaucoma surgery was lower in the HMS group (2.4% vs. 6.2%; P = 0.027, log-rank test). No clinical or statistically significant differences were found in the rate of endothelial cell loss from 3 to 60 months between the HMS and CS alone groups (P = 0.261). CONCLUSIONS: The addition of a Schlemm's canal microstent in conjunction with CS was safe, resulted in lowered IOP and medication use, and reduced the need for postoperative incisional glaucoma filtration surgery compared with CS after 5 years. Long-term presence of the implant did not affect the corneal endothelium adversely.

Intraocular Lens Complications: Decentration, Uveitis-Glaucoma-Hyphema Syndrome, Opacification, and Refractive Surprises.

As cataract surgery has evolved, intraocular lens (IOL) complications are rare. The purpose of this review was to report the incidence, diagnosis, and management of IOL decentrations, uveitis-glaucoma-hyphema (UGH) syndrome, IOL opacifications, and refractive surprises. Literature review was performed by searching PubMed, MEDLINE, EMBASE, and the Cochrane Controlled Trial Database and the reference lists of original studies as well as reviews. Intraocular lens decentrations and dislocations can appear at any time, particularly in patients with predisposing factors such as pseudoexfoliation, prior vitreoretinal surgery, or trauma. Recognizing when they require surgical intervention for UGH or to improve visual function is critical in limiting long-term sequela. Intraocular lens opacifications such as glistenings rarely require intervention, but others, such as subsurface nanoglistenings, calcifications, or discolorations, may require IOL exchange. Finally, despite our best efforts to enhance measurements and IOL calculations, refractive surprises still occur. Intraocular lens complications are uncommon with modern cataract surgery. A number of these complications require proper identification and care to optimize patient outcomes.

Three-Year Findings of the HORIZON Trial: A Schlemm Canal Microstent for Pressure Reduction in Primary Open-Angle Glaucoma and Cataract.

PURPOSE: To report 3-year outcomes of the HORIZON study comparing cataract surgery (CS) with Hydrus Microstent (Ivantis, Inc) implantation versus CS alone. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Five hundred fifty-six eyes from 556 patients with cataract and primary open-angle glaucoma (POAG) treated with 1 or more glaucoma medication, washed out diurnal intraocular pressure (IOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: After phacoemulsification, eyes were randomized 2:1 to receive a Hydrus Microstent or no stent. Follow-up included comprehensive eye examinations through 3 years. MAIN OUTCOME MEASURES: Outcome measures included IOP, medical therapy, reoperation rates, visual acuity, adverse events, and changes in corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to microstent treatment and 187 to CS only. Preoperative IOP, medication use, washed-out diurnal IOP, and glaucoma severity did not differ between the two treatment groups. At 3 years, IOP was 16.7 ± 3.1 mmHg in the microstent group and 17.0 ± 3.4 mmHg in the CS group (P = 0.85). The number of glaucoma medications was 0.4 ± 0.8 in the microstent group and 0.8 ± 1.0 in the CS group (P < 0.001), and 73% of microstent group eyes were medication free compared with 48% in the CS group (P < 0.001). The microstent group included a higher proportion of eyes with IOP of 18 mmHg or less without medications compared with the CS group (56.2% vs. 34.6%; P < 0.001), as well as IOP reduction of at least 20%, 30%, or 40% compared with CS alone. The cumulative probability of incisional glaucoma surgery was lower in the microstent group (0.6% vs. 3.9%; hazard ratio, 0.156; 95% confidence interval, 0.031-0.773; P = 0.020). No difference was found in postoperative corneal endothelial cell loss between groups. No procedure- or device-related serious adverse events resulting in vision loss occurred in either group. CONCLUSIONS: Combined CS and microstent placement for mild to moderate POAG is safe, more effective in lowering IOP with fewer medications, and less likely to result in further incisional glaucoma filtration surgery than CS alone at 3 years.

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma: The COMPARE Study.

PURPOSE: To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG). DESIGN: Prospective, multicenter, randomized clinical trial. PARTICIPANTS: 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. INTERVENTION: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION: 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.

Glaucoma screening: where are we and where do we need to go?

PURPOSE OF REVIEW: Current recommendations for glaucoma screening are decidedly neutral. No studies have yet documented improved long-term outcomes for individuals who undergo glaucoma screening versus those who do not. Given the long duration that would be required to detect a benefit, future studies that may answer this question definitively are unlikely. Nevertheless, advances in artificial intelligence and telemedicine will lead to more effective screening at lower cost. With these new technologies, additional research is needed to determine the costs and benefits of screening for glaucoma. RECENT FINDINGS: Using optic disc photographs and/or optical coherence tomography, deep learning systems appear capable of diagnosing glaucoma more accurately than human graders. Eliminating the need for expert graders along with better technologies for remote imaging of the ocular fundus will allow for less expensive screening, which could enable screening of individuals with otherwise limited healthcare access. In India and China, where most glaucoma remains undiagnosed, glaucoma screening was recently found to be cost-effective. SUMMARY: Recent advances in artificial intelligence and telemedicine have the potential to increase the accuracy, reduce the costs, and extend the reach of screening. Further research into implementing these technologies in glaucoma screening is required.

A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study.

OBJECTIVE: 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. DESIGN: Prospective, multicenter, single-masked, randomized controlled trial. PARTICIPANTS: Subjects with concomitant primary open-angle glaucoma (POAG), visually significant cataract, and washed-out modified diurnal IOP (MDIOP) between 22 and 34 mmHg. METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Cyclodialysis cleft repair: A multi-centred, retrospective case series.

IMPORTANCE: There is a paucity of evidence analysing the treatment of cyclodialysis clefts. BACKGROUND: We describe outcomes following the treatment of this rare condition at six centres internationally. DESIGN: Retrospective case series. PARTICIPANTS: Thirty-six patients with a cyclodialysis cleft from 2003 to 2017 were recruited. METHODS: Clefts were treated with cycloplegic agents, laser therapy and/or surgery. MAIN OUTCOME MEASURES: Postoperative best recorded visual acuity (BRVA), intraocular pressure (IOP) and the rate of cleft closure. RESULTS: The mean age was 45 ± 17 years and 29 (80.6%) patients were male. One eye (2.8%) received only medical therapy, 5 (13.9%) received laser, 14 (38.9%) underwent surgery after laser failure and 16 (44.4%) eyes received exclusively surgery. Over 80% of eyes had a BRVA improvement of more than two lines. Closure was attained in 30 eyes (93.8%; n = 32), with postoperative stabilized IOP ≥ 12 mmHg in 29 eyes (80.6%; n = 36) and postoperative BRVA ≤20/50 in 20 eyes (58.8%; n = 34). Improved postoperative BRVA was related to better preoperative BRVA (P = 0.006) and preoperative IOP ≥ 4 mmHg (P = 0.03). There was no significant difference between treatment approach for IOP ≥ 12 mmHg (P = 0.85) or postoperative BRVA ≤20/50 (P = 0.80). Only two eyes at last follow-up required IOP lowering medication. CONCLUSIONS AND RELEVANCE: There was a high closure rate with most eyes eventually requiring surgery. Clinically significant improvements in BRVA were found in most eyes. Improved postoperative BRVA was significantly related to better preoperative BRVA and IOP.

Interocular Axial Length and Corneal Power Differences as Predictors of Postoperative Refractive Outcomes after Cataract Surgery.

PURPOSE: To determine whether differences between eyes in axial length (AL) and corneal power (K) on optical biometry are predictive of refractive outcomes. DESIGN: Retrospective cohort study. PARTICIPANTS: A total of 729 patients (1458 eyes) who underwent bilateral phacoemulsification at TLC (Mississauga, Ontario, Canada) from September 2013 to August 2015. METHODS: We compared the proportion of patients having >0.5 diopters (D) of refractive error from target stratified by interocular axial length differences (IALDs) and interocular K differences (IKDs) between eyes as measured by optical biometry (IOL-Master, Carl Zeiss Meditec, Oberkochen, Germany). Analysis was repeated for 0.25 D or 1.0 D targets and for patients with uncorrected visual acuity (UCVA) >0.3 logarithm of the minimum angle of resolution (logMAR) postoperatively. MAIN OUTCOME MEASURES: Proportions, odds ratios (ORs), and corresponding 95% confidence intervals (CIs) were computed using generalized estimating equations to account for within-patient correlation. RESULTS: Some 79.1% of eyes were ≤0.5 D of refractive target, 47.0% were ≤0.25 D, and 97.2% were ≤1.0 D. The OR of having a refractive outcome >0.5 D from target for IALD cutoff of 0.2 mm was 1.4 (1.1-1.8), of 0.3 mm was 1.6 (1.2-2.1), and of 0.4 mm was 1.8 (1.3-2.5). This translates to 70.0% (63.5-75.7) within target for IALD of ≥0.4 mm versus 80.7% (78.4-82.9) for <0.4 mm. For a given patient with IALD, the chance of being off target was similar for the shorter and longer eye. Eyes outside of target were twice as likely to be <-0.5 D than >0.5 D. Interocular K difference was largely not associated with prediction error, yet larger IKD-flat, steep, and average were associated with increased odds of UCVA >0.3 logMAR postoperatively. CONCLUSIONS: Interocular axial length difference of as little as ≥0.2 mm is associated with a higher chance of >0.5 D of refractive error from target and worse UCVA. Interocular K difference was not associated with worse refractive error from target, although a difference of ≥0.4 D was associated with worse UCVA. These cutoffs should be considered in preoperative planning and discussion with patients. Future study is required to assess whether repeating measurements, using adjunctive measurement devices, or attempting to separate true differences from artifact based on preoperative refractive characteristics reduces residual refractive error.

Visual and Refractive Outcomes in Manual versus Femtosecond Laser-Assisted Cataract Surgery: A Single-Center Retrospective Cohort Analysis of 1838 Eyes.

PURPOSE: Femtosecond laser-assisted cataract surgery (FLACS) has emerged as an alternative to manual cataract surgery (MCS) for corneal incision and capsulorhexis creation, as well as nuclear fragmentation. This study compares postoperative refractive and visual outcomes in eyes receiving MCS or FLACS. DESIGN: Single-center, comparative, retrospective cohort analysis. PARTICIPANTS: Consecutive eyes receiving FLACS and MCS from July 1, 2012, to July 31, 2015, at a single tertiary care center. METHODS: Demographic data, ocular history, preoperative measurements and biometry, and postoperative surgical results were retrospectively obtained and statistically analyzed using a generalized linear mixed model adjusting for differences in baseline characteristics and within-patient correlation. A 2-tailed P value <0.05 was considered statistically significant throughout the study. MAIN OUTCOME MEASURES: Percentage of eyes achieving absolute error (AE) ≤0.5 diopters (D). Secondary outcomes included percentage of eyes with AE ≤0.25 D and ≤1.0 D, and percentage of distance-targeted eyes achieving uncorrected distance visual acuity (UDVA) of 20/20 or better, 20/25 or better, and 20/30 or better. RESULTS: A total of 883 eyes received MCS and 955 received FLACS among 1089 patients. Some 82.6% of FLACS eyes and 78.8% of MCS eyes had ≤0.5 D of AE at 3 weeks, representing an adjusted odds ratio (OR) of 1.28 (95% confidence interval [CI], 0.98-1.66) of FLACS relative to MCS being within target. Some 97.1% of FLACS and 97.2% of MCS eyes had ≤1.0 D of AE (OR, 0.96; 95% CI, 0.57-1.60) and 49.3% of FLACS and 46.3% of MCS eyes, ≤0.25 D of AE (OR, 1.13; 95% CI, 0.91-1.39). Factors predictive of a favorable refractive outcome included axial length between 22 and 24.8 mm, receiving a toric intraocular lens, less preoperative cylinder, and greater preoperative average keratometry. There was no significant difference in the percentage of patients targeted for distance who achieved UDVA of 20/20 or better (P = 0.30), 20/25 or better (P = 0.06), or 20/30 or better (P = 0.66) vision. CONCLUSIONS: Postoperatively, there was no statistically significant difference found between eyes undergoing FLACS and eyes undergoing MCS with respect to refractive and visual outcomes.

Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy.

PURPOSE: To compare the efficacy, safety, and risk factors for failure of standalone ab interno gelatin microstent implantation with mitomycin C (MMC) versus trabeculectomy with MMC. DESIGN: International, multicenter, retrospective interventional cohort study. PARTICIPANTS: Three hundred fifty-four eyes of 293 patients (185 microstent and 169 trabeculectomy) with no prior incisional surgery. METHODS: Consecutive eyes with uncontrolled glaucoma underwent microstent or trabeculectomy surgery from January 1, 2011 through July 31, 2015 at 4 academic ophthalmology centers: Toronto, Canada; Frankfurt, Germany; Salzburg, Austria; and Leuven, Belgium. MAIN OUTCOME MEASURES: Primary outcome measure was hazard ratio (HR) of failure, with failure defined as 2 consecutive intraocular pressure (IOP) readings of <6 mmHg with vision loss or >17 mmHg without glaucoma medications (complete success) at least 1 month after surgery despite in-clinic interventions (including needling). Secondary outcome measures included IOP thresholds of 6 to 14 mmHg and 6 to 21 mmHg and same thresholds allowing for medications (qualified success), interventions, complications, and reoperations. RESULTS: Baseline characteristics were similar, except more men (56% vs. 43%), younger patients (average, by 3 years), better preoperative visual acuity (22% vs. 32% with 0.4 logarithm of the minimum angle of resolution vision or worse), and more trabeculoplasty (52% vs. 30%) among microstent eyes. The adjusted HR of failure of the microstent relative to trabeculectomy was 1.2 (95% confidence interval [CI], 0.7-2.0) for complete success and 1.3 (95% CI, 0.6-2.8) for qualified success, and similar for other outcomes. Time to 25% failure was 11.2 months (95% CI, 6.9-16.1 months) and 10.6 months (95% CI, 6.8-16.2 months) for complete success and 30.3 months (95% CI, 19.0-∞ months) and 33.3 months (95% CI, 25.7-46.2 months) for qualified success. Overall, white ethnicity was associated with decreased risk of failure (adjusted HR, 0.49; 95% CI, 0.25-0.96), and diabetes was associated with increased risk of failure (adjusted HR, 4.21; 95% CI, 2.10-8.45). There were 117 and 165 distinct interventions: 43% and 31% underwent needling, respectively, and 50% of trabeculectomy eyes underwent laser suture lysis. There were 22 and 30 distinct complications, although most were transient. Ten percent and 5% underwent reoperation (P = 0.11). CONCLUSIONS: There was no detectable difference in risk of failure and safety profiles between standalone ab interno microstent with MMC and trabeculectomy with MMC.

Hydrus microstent compared to selective laser trabeculoplasty in primary open angle glaucoma: one year results.

BACKGROUND: To compare the reduction of intraocular pressure (IOP) and glaucoma medications following selective laser trabeculoplasty (SLT) versus stand-alone placement of the Hydrus microstent, a microinvasive glaucoma surgery device. DESIGN: Prospective interventional case-series. University practice. PARTICIPANTS: Fifty six eyes (56 patients) with uncontrolled primary open-angle glaucoma. METHODS: Patients received either SLT (n = 25) or Hydrus implantation (n = 31) in two centres. Patients were evaluated at baseline and 1, 7 days, 1, 3, 6 and 12 months after surgery. MAIN OUTCOME MEASURES: Intraocular pressure and number of glaucoma medications variations inter-groups and intra-groups. RESULTS: There were no significant differences at baseline between groups, but the mean deviation was worse in the Hydrus group (-8.43 ± 6.84 dB, confidence limits (CL)-2.8/-3.3 vs.-3.04 ± 0.65 dB, CL-6/-10.8; P < 0.001). After 12 months, there was a significant decrease in IOP and medications in the Hydrus group compared with baseline values. In the SLT group, only the decrease in IOP was significant. There was 3-fold greater reduction in medication use in the Hydrus group compared with SLT (-1.4 ± 0.97 vs.-0.5 ± 1.05, P = 0.001). 47% of patients were medication free at 12 months in the Hydrus group (4% in the SLT group). No complications were recorded in the SLT group. In the Hydrus group, three patients experienced a temporary reduction of visual acuity post-operatively, and two patients had post-operative IOP spikes that resolved within one week. CONCLUSIONS: Both SLT and Hydrus implantation reduced IOP without serious adverse events. Hydrus implantation led to a significant and further reduction in medication dependence at 12 months.

Efficacy and Safety of Femtosecond Laser-Assisted Cataract Surgery Compared with Manual Cataract Surgery: A Meta-Analysis of 14 567 Eyes.

TOPIC: To investigate the efficacy and safety of femtosecond laser-assisted cataract surgery (FLACS) relative to manual cataract surgery (MCS). CLINICAL RELEVANCE: It is unclear whether FLACS is more efficacious and safe relative to MCS. METHODS: A literature search of MEDLINE, EMBASE, and Scopus from 2007 to March 2016 was conducted. Studies containing both FLACS and MCS arms that reported on relevant efficacy and/or safety parameters were included. Weighted mean differences (WMDs) and risk ratios (RRs) with 95% confidence intervals (CIs) were calculated. RESULTS: From 2802 screened articles, 14 567 eyes from 15 randomized controlled trials and 22 observational cohort studies were included. For primary visual and refractive outcomes, no statistically significant difference was detected between FLACS and MCS in uncorrected distance visual acuity (WMD, -0.02; 95% CI, -0.04 to 0.01; P = 0.19), corrected distance visual acuity (WMD, -0.01; 95% CI, -0.02 to 0.01; P = 0.26), and mean absolute error (WMD, -0.02; 95% CI, -0.07 to 0.04; P = 0.57). In terms of secondary surgical end points, there was a statistically significant difference in favor of FLACS over MCS for effective phacoemulsification time (WMD, -3.03; 95% CI, -3.80 to -2.25; P < 0.001), capsulotomy circularity (WMD, 0.16; 95% CI, 0.11-0.21; P < 0.001), postoperative central corneal thickness (WMD, -6.37; 95% CI, -11.88 to -0.86; P = 0.02), and corneal endothelial cell reduction (WMD, -55.43; 95% CI, -95.18 to -15.69; P = 0.006). There was no statistically significant difference between FLACS and MCS for total surgery time (WMD, 1.25; 95% CI, -0.08 to 2.59; P = 0.07), capsulotomy circularity using a second formula (WMD, 0.05; 95% CI, -0.01 to 0.12; P = 0.10), and corneal endothelial cell count (WMD, 73.39; 95% CI, -6.28 to 153.07; P = 0.07). As well, there was a significantly higher concentration of prostaglandins after FLACS relative to MCS (WMD, 198.34; 95% CI, 129.99-266.69; P < 0.001). Analysis of safety parameters revealed that there were no statistically significant differences in the incidence of overall complications between FLACS and MCS (RR, 2.15; 95% CI, 0.74 to 6.23; P = 0.16); however, posterior capsular tears were significantly more common in FLACS versus MCS (RR, 3.73; 95% CI, 1.50-9.25; P = 0.005). CONCLUSIONS: There were no statistically significant differences detected between FLACS and MCS in terms of patient-important visual and refractive outcomes and overall complications. Although FLACS did show a statistically significant difference for several secondary surgical outcomes, it was associated with higher prostaglandin concentrations and higher rates of posterior capsular tears.

Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts.

PURPOSE: We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery. DESIGN: Multicenter (24 US sites), interventional randomized clinical trial (RCT) (ClinicalTrials.gov identifier, NCT01085357). PARTICIPANTS: Subjects were enrolled beginning July 2011, with study completion in March 2015. Subjects had POAG with mean diurnal unmedicated intraocular pressure (IOP) 21-33 mmHg and were undergoing phacoemulsification cataract surgery. METHODS: After completing cataract surgery, subjects were intraoperatively randomized to phacoemulsification only (control) or supraciliary microstenting with phacoemulsification (microstent) groups (1:3 ratio). Microstent implantation via an ab interno approach to the supraciliary space allowed concomitant cataract and glaucoma surgery. MAIN OUTCOME MEASURES: Outcome measures included percentage of subjects achieving ≥20% unmedicated diurnal IOP lowering versus baseline, mean IOP change and glaucoma medication use, and ocular adverse event (AE) incidence through 24 months. RESULTS: Of 505 subjects, 131 were randomized to the control group and 374 were randomized to the microstent group. Baseline mean IOPs in the control and microstent groups were similar: 24.5±3.0 and 24.4±2.8 mmHg, respectively (P > 0.05); mean medications were 1.3±1.0 and 1.4±0.9, respectively (P > 0.05). There was early and sustained IOP reduction, with 60% of controls versus 77% of microstent subjects achieving ≥20% unmedicated IOP lowering versus baseline at 24 months (P = 0.001; per-protocol analysis). Mean IOP reduction was ↓7.4 mmHg for the microstent group versus ↓5.4 mmHg in controls (P < 0.001), with 85% of microstent subjects not requiring IOP medications at 24 months. Mean 24-month medication use was 67% lower in microstent subjects (P < 0.001); 59% of control versus 85% of microstent subjects were medication free. Mean medication use in controls decreased from 1.3±1.0 drugs at baseline to 0.7±0.9 and 0.6±0.8 drugs at 12 and 24 months, respectively, and in the microstent group from 1.4±0.9 to 0.2±0.6 drugs at both 12 and 24 months (P < 0.001 for reductions in both groups at both follow-ups vs. baseline). No vision-threatening microstent-related AEs occurred. Visual acuity was high in both groups through 24 months; >98% of all subjects achieved 20/40 best-corrected visual acuity or better. CONCLUSIONS: This RCT demonstrated safe and sustained 2-year reduction in IOP and glaucoma medication use after microinterventional surgical treatment for mild-to-moderate POAG.

Glaucoma and cataract surgery: two roads merging into one.

PURPOSE OF REVIEW: To discuss the increasing utilization of cataract extraction in the management of glaucoma and to highlight advances in surgical care that can promote synergistic treatment of these comorbid conditions. RECENT FINDINGS: Recent years have demonstrated significant advances in the management of glaucoma through the use of novel microinvasive glaucoma devices. Furthermore, an increased understanding of the role of cataract surgery in the treatment of various glaucomas warrants review. Nevertheless, cataract surgery in the glaucoma patient warrants specific preoperative, intraoperative, and postoperative planning to optimize visual function and quality of life while mitigating potential risk factors for adverse events. SUMMARY: Although the challenges of performing cataract extraction on glaucoma patients exist, the potential benefit to these patients is substantial. With attention to pre- and perioperative surgical planning and intraoperative technique, as well as with awareness and potential utilization of novel devices and treatment strategies, cataract extraction offers a unique platform for anatomical and functional improvement in this increasingly common cohort of patients.

Inter-eye differences in patients with pseudoexfoliation syndrome presenting with intraocular lens dislocation.

PURPOSE: To analyze differences in glaucoma diagnosis and glaucoma severity between fellow eyes in patients with pseudoexfoliation syndrome (PXF) who present with intraocular lens (IOL) dislocation. DESIGN: Retrospective matched case-control study. Eyes presenting with IOL dislocation (case group) were compared with fellow eyes (control group). PARTICIPANTS: Patients from a tertiary referral practice in Mississauga, Ontario, Canada. METHODS: Consecutive patients with PXF and prior bilateral uneventful cataract surgeries with in-the-bag IOLs who presented with IOL dislocation between 2008 and 2013 were identified (n=71). Indicators of glaucoma severity were compared between fellow eyes using McNemar's test and Wilcoxon signed-rank tests. Indicators of glaucoma severity were also compared pre- and post-IOL exchange/repositioning in the eye with IOL dislocation. MAIN OUTCOME MEASURES: Glaucoma diagnosis, corrected distance visual acuity (CDVA), intraocular pressure (IOP), optic nerve cup-to-disc (C/D) ratio, mean deviation (MD) on visual field, retinal nerve fiber layer (RNFL) thickness, and glaucoma medication requirements (GMRs). RESULTS: Seventy-one participants were included. The affected eye was more likely to have glaucoma (P<0.0001) and have more severe glaucoma (P=0.0001). In addition, the affected eye had worse mean CDVA (1.14±0.79 logarithm of the minimum angle of resolution [logMAR] vs. 0.35±0.46 logMAR, P<0.0005), higher mean IOP (19.2±7.2 vs. 14.7±3.6, P<0.0005), higher C/D ratio (0.54±0.22 vs. 0.51±0.20, P=0.006), greater mean number of glaucoma medication classes (1.4±1.4 vs. 0.5±1.1, P<0.0005), worse MD (-13.83±6.89 decibels [dB] vs. -6.59±6.63 dB, P<0.0005), and worse mean RNFL thickness (69.2±26.3 vs. 82.4±13.7, P=0.001). In the affected eye, there were early postoperative improvements in mean CDVA, IOP, and GMRs. CONCLUSIONS: In patients with PXF, the eye presenting with IOL dislocation was more likely than its fellow eye to have a diagnosis of glaucoma and to have glaucoma of greater severity.

Effects of a Schlemm canal scaffold on collector channel ostia in human anterior segments.

This study evaluates the morphologic effect of the implantation of two different sizes of the Hydrus microstent on the outer wall of Schlemm's canal (SC) and collector channel (CC) ostia. Twelve human eyes were dissected at the equator removing the iris, lens, ciliary body and vitreous. The cornea was excised with a corneal trephine exposing a direct view of the angle while leaving the trabecular meshwork (TM) intact. The Hydrus delivery system was used to deliver microstents of 8 mm and 15 mm in length into SC. Following delivery, the tissues were immediately immersed in fixative. After tissue fixation, the microstents were gently lifted out of SC through the TM leaving a small slit opening in the TM. The slit opening was widened by gently dissecting the entire TM. Control eyes underwent dissection before fixation by gently removing the TM exposing the outer wall of SC. The tissues were prepared for scanning electron microscopy (SEM). The external wall of SC was imaged using SEM and were reviewed with particular attention focused on the distribution of irregular particulate matter (IPM), the shape of the CC ostia and the health of the SC endothelium. Three eyes received the 8 mm microstent, two the 15 mm microstent and 6 eyes served as controls. Five of the controls had reported histories of glaucoma while all other eyes were normal. All eyes showed evidence of removal of the trabecular meshwork revealing the external wall of SC. CCs were regularly visible in all eyes and were not obstructed, compressed or their margins disrupted. Nuclear profiles were oriented circumferentially in SC except at regions of CC ostia where they assumed a radial configuration oriented toward the lumen of the CC. The area of microstent contact with SC external wall was examined with SEM and a comparison made between the 8 and 15 mm microstent showing a smaller area of indentation with the 8 mm microstent. The indentations were generally free of particulate debris, were smooth and were devoid of nuclear profiles. In bridged areas adjacent to areas of microstent contact, CCs were identified, appearing patent and intact like those of the control eyes. The eyes receiving 8 mm and 15 mm Hydrus microstents both maintained CC ostia patency but a smaller area of external wall contact was evident from insertion of the 8 mm microstent.