A Health-Related Quality of Life Measure for Patients Who Undergo Minimally Invasive Glaucoma Surgery.

PURPOSE: To develop a patient-reported outcome measure to assess the impact of glaucoma and treatment, including minimally invasive glaucoma surgery (MIGS). DESIGN: Observational study before and after concomitant cataract and Food and Drug Administration-approved implantable MIGS device surgery. SETTING: Survey administration was on a computer, iPad, or similar device. PATIENT POPULATION: 184 adults completed the baseline survey, 124 a survey 3 months after surgery, and 106 the 1-month test-retest reliability survey. The age range was 37 to 89 (average age = 72). Most were female (57%), non-Hispanic White (81%), and had a college degree (56%). MAIN OUTCOME MEASURES: The Glaucoma Outcomes Survey (GOS) assesses functional limitations (27 items), vision-related symptoms (7 items), psychosocial issues (7 items), and satisfaction with microinvasive glaucoma surgery (1 item). These multiple-item scales were scored on a 0 to 100 range, with a higher score indicating worse health. RESULTS: Internal consistency reliability estimates ranged from 0.75 to 0.93, and 1-month test-retest intraclass correlations ranged from 0.83 to 0.92 for the GOS scales. Product-moment correlations among the scales ranged from 0.56 to 0.60. Improvement in visual acuity in the study eye from baseline to the 3-month follow-up was significantly related to improvements in GOS functional limitations (r = 0.18, P = .0485), vision-related symptoms (r = 0.19, P = .0386), and psychosocial concerns (r = 0.18, P = .0503). Responders to treatment ranged from 17% for vision-related symptoms to 48% for functional limitations. CONCLUSIONS: This study supports using the GOS for ophthalmic procedures such as MIGS. Further evaluation of the GOS in different patient subgroups and clinical settings is needed.

Effect of Preoperative Trabecular Meshwork Pigmentation and Other Eye Characteristics on Outcomes of Combined Phacoemulsification/Minimally Invasive Glaucoma Surgery.

PURPOSE: To investigate associations between pigmentation of the trabecular meshwork (PTM) and other preoperative eye characteristics and outcomes of minimally invasive glaucoma surgery combined with phacoemulsification (Phaco/MIGS). DESIGN: Retrospective interventional case series. PARTICIPANTS: Academic glaucoma clinic patients with symptomatic cataract and glaucoma treated with combined Phaco/MIGS. METHODS: Analyzing preoperative PTM, intraocular pressure (IOP), IOP-lowering medications and visual acuity (VA) data in relation to Phaco/MIGS outcomes. MAIN OUTCOME MEASURES: Pigmentation of the trabecular meshwork and other preoperative eye characteristics in relation to Phaco/MIGS success defined as postoperative IOP between 5 and 21 mmHg and IOP reduction of ≥ 20% and/or a reduction of ≥ 1 IOP-medications compared to baseline, and final IOP, IOP-lowering medications and VA. RESULTS: A total of 265 eyes (172 patients, mean age, 73.5 [standard deviation, 10.0], range 35-95 years, male 40.0%) were identified and categorized with high PTM (108 eyes, 40.8%) or low PTM (157 eyes, 59.2%). The high PTM group, compared with the low PTM group, demonstrated higher preoperative IOP (16.7 [standard error 0.4] vs. 15.2 [0.4] mmHg, P = 0.009), included more eyes with primary open-angle glaucoma (POAG, P = 0.03), fewer eyes with normal-tension glaucoma (NTG, P = 0.01), and fewer eyes with mild stage glaucoma (P = 0.001). Compared to baseline, final IOP decreased by 6.5 [2.4]% and 13.4 [3.0]% (P = 0.075) to 13.5 [0.3] mmHg and 13.6 [0.4] mmHg (P = 0.77) in the low and high PTM groups, respectively, and IOP-lowering medications decreased by 34.6 [4.9]% (n = 116) and 18.1 [7.3]% (n = 85), respectively (P = 0.062). Surgical success was 59.9% and 58.3%, respectively (P = 0.87). It was positively associated with higher preoperative IOP (hazard ratio 1.08 [95% confidence interval 1.04-1.12] P < 0.0001) and higher number of preoperative IOP-medications (1.20 [1.05-1.37] P = 0.007), negatively associated with history of selective laser trabeculoplasty (SLT, 0.40 [0.23-0.68] P = 0.0009) and longer axial length (0.87 [0.80-0.94], P = 0.0006), but was not associated with PTM. CONCLUSIONS: Higher PTM was associated with POAG rather than NTG, with more severe glaucoma and higher preoperative IOP, but not with Phaco/MIGS success. Surgical success was positively associated with higher preoperative IOP and number of IOP-medications and negatively associated with history of SLT and longer axial length. These findings may help guide glaucoma surgeons in surgical planning and patient counseling. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Corneal Parameters after Tube-Shunt Implantation through the Ciliary Sulcus.

PURPOSE: To monitor bilateral corneal parameters after unilateral Baerveldt 350 tube-shunt implantation (Advanced Medical Optics, Santa Ana, CA) through the ciliary sulcus. DESIGN: Retrospective, interventional case series. PARTICIPANTS: Patients from 1 private glaucoma practice with severe uncontrolled glaucoma treated with sulcus tube-shunt implantation in 1 pseudophakic eye. METHODS: Specular microscopy data were collected before and after unilateral sulcus tube-shunt implantation from the surgical and the glaucomatous fellow eyes. MAIN OUTCOME MEASURES: Central corneal endothelial cell density (CECD), coefficient of variation (CV), percent of hexagonal cells, central corneal thickness (CCT), intraocular pressure (IOP), IOP-lowering medications, visual acuity, and complications. RESULTS: Forty-six patients (mean age, 69.9 years; standard deviation [SD], 4.6 years; range, 20-88 years; male gender, 41.3%) were identified. After surgery, IOP and the number of IOP-lowering medications decreased significantly by 42.3% (P < 0.0001) and 32.1% (P < 0.0001), respectively, in the surgical eye group. Preoperative CECD measured 1807 cells/mm2 (SD, 172 cells/mm2) and 1825 cells/mm2 (SD, 172 cells/mm2) in the surgical and fellow eyes, respectively (P = 0.92), and compared with baseline, it decreased by 8.6% (P = 0.17) and 3.1% (P = 0.65), respectively, by 24 months. Preoperative CV, percent of hexagonal cells, and CCT were similar in both groups and remained stable. All corneal parameters remained unchanged in a subgroup of 15 patients with low preoperative CECD (1273 cells/mm2; SD, 99 cells/mm2). Best-corrected visual acuity remained stable in both groups. Hyphema occurred in 23.9% of the surgical eyes and resolved with no intervention. We found no sight-threatening complications or corneal failures during follow-up. CONCLUSIONS: Tube-shunt implantation through the ciliary sulcus in pseudophakic eyes appears relatively safe to the corneal endothelium, demonstrating a small and nonsignificant decline in central CECD compared with baseline and with glaucomatous fellow eyes. No significant disruption to corneal endothelial cell morphologic features, increased corneal thickness, or corneal failures were found during the 24-month follow-up period. A prospective head-to-head comparison to assess the effects of the various methods of tube-shunt implantation on the corneal endothelium is needed.

Intraocular Pressure After Cataract Surgery Combined With Ab Interno Trabeculectomy Versus Trabecular Micro-bypass Stent: An Intrasubject Same-surgeon Comparison.

PRECIS: Combining Trabectome or iStent with phacoemulsification equally reduces intraocular pressure (IOP) and IOP-lowering medication burden during a 24-month follow-up, with a possible advantage to the Trabectome in the early postoperative period. PURPOSE: Intrasubject same-surgeon comparison between phacoemulsification combined with Trabectome (Phaco/Trabectome) versus one first-generation iStent (Phaco/iStent). SETTINGS: Private glaucoma and cataract practice. DESIGN: This is a retrospective interventional case series. METHODS: Data collected at 3 to 4 and 20 to 24 hours and up to 30 months following Phaco/Trabectome in 1 eye and Phaco/iStent in the contralateral eye in patients with bilateral visually-significant cataract and open-angle glaucoma. Evaluations included IOP, intraocular pressure-lowering medications (IOPmeds), visual acuity, and complications. RESULTS: Forty-five patients (90 eyes) were identified (age 76.5, 57 to 95 y). At 3 to 4 hours, IOP was above baseline in 12 and 13 eyes following Phaco/Trabectome and Phaco/iStent, respectively, but the degree of IOP elevation was smaller (P=0.048) following Phaco/Trabectome: 4.3 mm Hg, 2.0 to 6.6 mm Hg (95% confidence interval) versus Phaco/iStent: 8.7 mm Hg, 3.8 to 13.6 mm Hg. At 20 to 24 hours, compared with baseline, IOP was significantly lower after Phaco/Trabectome (P=0.004) but not after Phaco/iStent (P=0.14) although the rate of hyphema was higher following Phaco/Trabectome (12/45 vs. 2/45 eyes, P=0.007). IOP reduction from baseline at 3 to 4 hours was significantly larger (P=0.020) in the 21 eyes with hyphema: -3.9, -6.4 to -1.4 versus the 69 eyes without hyphema: -0.3, -2.0 to +1.4. At 1, 6, 12, and 24 months, IOP and number of IOPmeds were similar and significantly lower compared with baseline following either procedure. No complications were encountered in either group. CONCLUSIONS: Combined phacoemulsification with either Trabectome or first-generation iStent similarly lowers IOP and IOPmeds burden at 1, 6, 12, and 24 months following surgery. The Trabectome may have an advantage in lowering IOP faster and lessening the degree of IOP elevations in the early postoperative period.

Two-year data comparison of ab interno trabeculectomy and trabecular bypass stenting using exact matching.

PURPOSE: To create a balanced comparison of ab interno trabeculectomy (AIT) (Trabectome) and trabecular bypass stenting (TBS) (iStent). SETTING: Eye and Ear Institute, Pittsburgh, Pennsylvania, Ross Eye Institute, Buffalo, New York, and Glaucoma Associates of Texas, Dallas, USA. DESIGN: Retrospective case series. METHODS: The primary outcome measure was an unmedicated intraocular pressure (IOP) of 21 mm Hg or less and the secondary measure was an unmedicated IOP reduction of 20% or more at 2 years. Patients were matched by baseline IOP, number of glaucoma medications, and glaucoma type using exact matching and by age using nearest neighbor matching. Individuals without a close match were excluded. All surgeries were combined with phacoemulsification. RESULTS: One hundred fifty-four AIT eyes and 110 TBS eyes were analyzed. Forty-eight AIT patients were exactly matched with 48 TBS patients. Both groups had a mean baseline IOP of 15.3 mm Hg ± 3.1 (SD). At 24 months, the mean IOP was 13.9 ± 3.3 mm Hg in AIT patients and 16.8 ± 2.8 mm Hg in TBS patients and the mean number of medications was 0.7 ± 1.0 and 1.7 ± 1.2, respectively (both P = .04). At 24 months, the IOP was 21 mm Hg or less without medications in 53% of AIT patients and 16.6% of TBS patients (P < .05). At that time, 17.6% of patients in the AIT group but no patient in the TBS group had an IOP reduction of 20% or more without medication. CONCLUSION: An exact matching comparison of AIT and TBS showed greater IOP reduction with fewer medications after AIT.

Clinical experience with urgent tube shunt implantation through the ciliary sulcus in phakic eyes.

PURPOSE: To review the clinical course and outcomes of 3 phakic, ischemic, and inflamed eyes in which we performed urgent tube shunt implantation through the ciliary sulcus without lensectomy. METHODS: This is a retrospective interventional case series. Three eyes of 3 diabetic patients with uncontrolled severe neovascular glaucoma, shallow anterior chambers with closed angles and poor view to the posterior segment, where concomitant lensectomy was not recommended due to uncontrolled uveitis and ischemia, underwent tube shunt implantation through the ciliary sulcus. Main outcome measures were surgical complications, especially injury to the crystalline lens, and postoperative intraocular pressure (IOP). RESULTS: No surgical complications, including injury to the crystalline lens, have occurred. We used surgical modifications to allow sufficient visualization of the sulcus area to avoid injury to the crystalline lens during scleral tunneling and tube insertion through the ciliary sulcus. Postoperatively, the uveitis, ischemia, and vision have improved and IOP was controlled throughout follow-up. Cataract surgery with pupilloplasty was performed in one eye a year later with no complications and no interruption to IOP control. CONCLUSIONS: Based on our small and limited retrospective study, and under unusual circumstances, urgent tube shunt implantation through the ciliary sulcus may be considered in phakic eyes with severely uncontrolled IOP, shallow anterior chambers and poor view to the posterior segment, and when concomitant lensectomy is not recommended. We advise the use of appropriate surgical modifications by experienced glaucoma surgeons to prevent intraoperative complications. Further and larger studies are needed to evaluate the safety of this surgical option.

Intraocular pressure 3 to 4 hours and 20 hours after cataract surgery with and without ab interno trabeculectomy.

PURPOSE: To evaluate intraocular pressure (IOP) immediately after cataract surgery with or without ab interno trabeculectomy (Trabectome) and whether trabeculectomy-related hyphema increases the risk for IOP spikes. SETTINGS: Private glaucoma practice. DESIGN: Retrospective interventional nonrandomized comparative chart review. METHODS: Intraocular pressure was measured 3 to 4 hours and 20 hours postoperatively. RESULTS: The combined group comprised 73 eyes of 73 patients and the cataract-only group, 75 eyes of 75 patients. The mean preoperative IOP was 15.8 mm Hg ± 3.6 (SD) and 14.9 ± 3.0 mm Hg, respectively (P = .09). In the combined group, the IOP decrease was significant at 3 to 4 hours (P = .0003) and 20 hours (P = .0007). In the cataract-only group, the IOP increased significantly (P < .0001 and P = .0035, respectively). The mean IOP was significantly lower in the combined group than in the cataract-only group at 3 to 4 hours (12.8 ± 5.9 mm Hg versus 19.7 ± 7.5 mm Hg) and 20 hours (12.7 ± 7.0 mm Hg versus 17.2 ± 5.9 mm Hg) (both P < .0001). Significantly fewer eyes in the combined group than in the cataract-only group had IOP spikes (overall, P = .0077; 3 to 4 hours, P = .001). Hyphema occurred in 35 eyes (47.9%) in the combined group; however, the IOP was similar with or without hyphema. Only 1 eye with an IOP spike in the combined group had hyphema. CONCLUSION: Combining ab interno trabeculectomy and cataract surgery reduced short-term postoperative IOP and the incidence of IOP spikes despite the common hyphema. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Clinical experience with sulcus-implanted Baerveldt glaucoma tube shunts fully concealed behind the iris in undilated pseudophakic eyes.

PURPOSE: To describe our clinical experience with ciliary sulcus-implanted Baerveldt glaucoma tube shunts entirely concealed behind the iris in undilated pseudophakic eyes (concealed tubes, CT group), compared with similarly implanted tubes whose openings remain fully exposed in the undilated pupillary area (nonconcealed tubes, NCT group). METHODS: A retrospective interventional nonrandomized comparative chart review. The main outcome measures were postoperative tube incarceration by the iris, and postoperative intraocular pressure (IOP) and the number of IOP-lowering medications. RESULTS: Fifteen eyes of 15 patients were identified in the CT group and 41 eyes of 41 patients in the NCT group. In the CT and NCT groups, the postoperative follow-up period was 14.4±10.2 months (mean±SD; range, 3 to 42 mo) and 22.9±18.1 months (mean±SD; range, 3 to 72 mo; P=0.08), respectively. Only 1 case of tube incarceration by the iris has occurred in the CT group (6.7%) and none in the NCT group. This eye was treated with laser iridotomy with no recurrence. Preoperative IOPs in the CT and the NCT groups were 27.2±9.6 mm Hg (mean±SD; range, 16 to 46 mm Hg) and 25.5±10.6 mm Hg (mean±SD; range, 12 to 59 mm Hg; P=0.6), respectively. The IOPs were significantly reduced to 13.3±4.1 mm Hg (mean±SD; range, 6 to 22 mm Hg; P=0.0001) and 10.8±4.4 mm Hg (mean±SD; range, 4 to 25 mm Hg; P=0.0001), respectively, at the final visit. The difference in the final visit IOP between the groups approached significance (P=0.056). The number of preoperative IOP-lowering medications was 3.9±0.7 (mean±SD; range, 2 to 5) and 4.0±1.0 (mean±SD; range, 1 to 6), respectively. It was significantly reduced to 1.9±1.2 (mean±SD; range, 0 to 4; P=0.0001) and 1.8±1.4 (mean±SD; range, 0 to 5; P=0.0001), respectively. There was no significant difference between the groups before (P=0.6) or after surgery (P=0.8). CONCLUSIONS: Although NCTs tend to have a lower final IOP compared with CTs, the latter are safe and effective and do not require surgical repositioning. Should a CT become occluded by the iris, an uncommon event in our study, it could be treated by laser iridotomy alone.