Update on Microinvasive Glaucoma Surgery.

PurposeTo evaluate 2-year safety and effectiveness of iStent inject® W implantation with phacoemulsification in adult Japanese open-angle glaucoma (OAG) patients.DesignMulticenter, prospective, post-market surveillance.MethodsEyes were evaluated preoperatively and at Day 1, Week 1, and Months (M) 1, 3, 6, 12, and 24. Primary outcome was M24 cumulative probability of success defined as no additional glaucoma surgery and intraocular pressure (IOP) < preoperative value and number of glaucoma medications ≤ preoperative value or IOP ≤ preoperative value and number of glaucoma medications < preoperative value. Other endpoints included cumulative probability of achieving American Academy of Ophthalmology Glaucoma (AAO) success criteria for minimally invasive glaucoma surgery with phacoemulsification, and changes in mean IOP, number of glaucoma medications, and medication costs over time. Subanalysis was based on OAG subtype [primary open-angle glaucoma (POAG), normal tension glaucoma (NTG), and exfoliative glaucoma (XFG)]. Adverse events were recorded.ResultsCumulative probability of success at M24 was 91.7%, 98.8%, 88.9%, and 85.0% for cohort (N = 214), NTG, XFG, and POAG, respectively. The AAO M24 success was 80.7%. Statistically significant reductions in mean IOP and number of medications were observed through M24 in cohort and OAG subtypes. At M24, the estimated reductions in mean (standard error) IOP and number of medications were 2.0 (0.5) mmHg and 1.9 (0.4), respectively, in the cohort. Adverse events were minimal. At M24, the average monthly glaucoma medication costs decreased by 49.7%.ConclusionJapanese OAG eyes treated with iStent inject W combined with phacoemulsification experienced reduced IOP and medication burden with minimal adverse events and high success rates over postoperative 2 years.

To compare intraocular pressure (IOP) control in eyes with or without clear corneal phacoemulsification following trabeculectomy. The study group included 30 eyes that underwent uneventful clear corneal phacoemulsification and foldable intraocular lens implantation following trabeculectomy without antimetabolites. Thirty eyes that had undergone filtering surgery without cataract extraction were selected as controls. Case and control groups were matched with respect to age, gender, IOP, number of glaucoma medications, glaucoma type (primary open-angle glaucoma/pseudoexfoliative glaucoma), trabeculectomy time and follow-up. Comparisons between the study and control groups (intergroup) and within the same group at different time-points (intragroup) were performed for IOP, glaucoma medications and bleb morphology. Success rates were investigated by Kaplan-Meier survival analysis and the factors influencing final success by logistic regression. Intraocular pressure (p = 0.04) and glaucoma medications (p = 0.001) increased during an average follow-up of 26.1 +/- 9.9 months in both groups. Intragroup differences became statistically significant after the 6-month visit, but intergroup differences remained insignificant. Bleb height decreased significantly following phacoemulsification in the study group (p = 0.017). Success rates decreased with time in both groups, with no intergroup difference (p = 0.46). The final success rate was negatively correlated with IOP and number of glaucoma medications used at the study entry, while there was a positive correlation between the baseline and final success rates. Trabeculectomy success decreased in a time-dependent manner in eyes with and without subsequent phacoemulsification. Uncomplicated clear corneal phacoemulsification was not found to have any additional unfavorable influence on IOP control in eyes with filtering blebs.

Phacoemulsification in eyes with functioning filtering blebs: a prospective study

Endoscopic cyclophotocoagulation and Kahook Dual Blade trabeculotomy in combination with phacoemulsification

Gonioscopy-assisted transluminal trabeculotomy (GATT) and goniotomy with Kahook Dual Blade both achieved sustained reductions in intraocular pressure (IOP) and medication burden in eyes with steroid-induced or uveitic glaucoma at 24 months. Both procedures had favorable safety profiles. To characterize the 24-month surgical outcomes of GATT and excisional goniotomy in eyes with steroid-induced or uveitic glaucoma. A retrospective chart review was performed of eyes with steroid-induced or uveitic glaucoma that underwent GATT or excisional goniotomy, either standalone or combined with phacoemulsification cataract surgery, by a single surgeon at the Cole Eye Institute. IOP, number of glaucoma medications, and steroid exposure were recorded preoperatively and at multiple postoperative timepoints up to 24 months. Surgical success was defined as at least 20% IOP reduction or IOP <12, 15, or 18mmHg (Criterion A, B, or C). Surgical failure was defined as need for additional glaucoma surgery or loss of light perception vision. Intraoperative and postoperative complications were reported. Forty eyes of 33 patients underwent GATT, and 24 eyes of 22 patients underwent goniotomy, of which 88% and 75%, respectively, had 24-months' follow-up. Concomitant phacoemulsification cataract surgery was performed in 38% (15/40) GATT eyes and 17% (4/24) goniotomy eyes. IOP and number of glaucoma medications were reduced at all postoperative timepoints in both groups. At 24 months, GATT eyes had mean IOP 12.9±3.5mmHg on 0.9±1.2 medications, and goniotomy eyes had mean IOP 14.3±4.1mmHg on 1.8±1.3 medications. Surgical failure was 8% for GATT and 14% for goniotomy at 24 months. Transient hyphema and transient IOP elevation were the most common complications, and 10% GATT eyes required surgical evacuation of hyphema. Both GATT and goniotomy demonstrate favorable efficacy and safety in steroid-induced and uveitic glaucoma eyes. Both procedures achieved sustained reductions in IOP and glaucoma medication burden at 24 months.

To evaluate the safety and efficacy of the iStent inject device combined with phacoemulsification in Asian eyes with primary open angle glaucoma. A retrospective study of combined phacoemulsification and iStent inject surgeries performed in a single institution from July 2017 to August 2019 on patients with co-existing cataracts and primary open angle glaucoma (POAG). Outcome measures included best-corrected visual acuity, intraocular pressure (IOP), number of glaucoma eyedrop medications, and surgical complications. A total of 95 eyes were included. Majority of subjects were male (59, 62.1%) and Chinese (83, 87.4%). Mean age was 74.7 ± 8.7 years. Pre-operatively, mean IOP was 16.2 ± 4.3 mmHg and number of medications was 1.9 ± 0.9. Significant post-operative reduction in mean IOP was observed at all timepoints - post-operative month (POM)1: 3.0 ± 5.6 mmHg reduction (n = 95, p < 0.05); POM3: 1.6 ± 3.8 mmHg (n = 66, p < 0.05); POM6: 1.8 ± 4.7 mmHg (n = 55, p < 0.05); POM12: 1.3 ± 4.2 mmHg (n = 48) (p < 0.05). The number of glaucoma medications was also reduced from a mean of 1.9 ± 0.8 to 0.6 ± 1.0 at POM12 (p < 0.05). Intraoperatively, one case of malignant glaucoma occurred. Post operatively, implant obstruction by iris was observed in two eyes post-operatively requiring iridoplasty. One case of cystoid macular edema and one case of drop in visual acuity due to glaucoma progression was/were also observed. Asian eyes undergoing combined phacoemulsification and iStent inject surgery demonstrate a significant and sustained reduction in both IOP and number of glaucoma medications. Overall, there is a good safety profile for iStent inject.

The Effect of Phacoemulsification on Intraocular Pressure in Eyes with Preexisting Glaucoma Drainage Implants

PurposeEfficacy and safety evaluation of Kahook Dual Blade (KDB) goniotomy vs iStent inject implantation.Materials and MethodsRetrospective study in patients that underwent goniotomy with KDB or iStent inject implantation, stand-alone or combined with cataract surgery. Main outcome parameters were intraocular pressure (IOP), number of glaucoma medications, proportion of eyes achieving >20% IOP reduction and number of eyes with postoperative IOP <19 mmHg at last follow-up.ResultsA total of 29 patients (30 eyes) were included in the iStent inject group and 30 patients (32 eyes) in the KDB group. Mean follow-ups were 20.9±6.5 (KDB-alone) to 29.5±7.6 (phaco-iStent inject) months. Pre- and post-operative IOPs were 22.2±5.8 mmHg and 15.9±4.3 mmHg (P=0.004) in the KDB-alone, 24.2±6.8 mmHg and 16.2±6.7 mmHg (P=0.001) in the phaco-KDB, 20.6±5.4 mmHg and 20.9±6.8 mmHg (P=0.598) in the iStent inject-alone as well as 20.9±5.5 mmHg and 15.6±3.4 mmHg (P=0.003) in the phaco-iStent inject subgroups. No major complications occurred.ConclusionAll KDB and iStent subgroups except the stand-alone iStent inject subgroup showed a clinically significant IOP-lowering effect as a stand-alone procedure or combined with cataract surgery. Goniotomy with KDB in this setting seems to offer an advantageous IOP reduction compared to iStent inject.

IntroductionThis study aims to evaluate the long-term clinical outcomes of excisional goniotomy with the Kahook Dual Blade (KDB) in the management of various types of glaucoma.MethodsThis was a retrospective, noncomparative chart review of 90 eyes of 53 patients with glaucoma that underwent standalone KDB goniotomy (KDB-alone group) or KDB goniotomy with concomitant phacoemulsification (KDB-phaco group) between October 2015 and October 2017. Surgical success was defined as an intraocular pressure (IOP) reduction by ≥ 20% at the last follow-up with no surgical reinterventions required and a final IOP ≥ 4 mmHg and ≤ 21 mmHg. We also report on changes from baseline in IOP, number of glaucoma medications, best-corrected visual acuity (BCVA), and visual field parameters, for up to 72 months.ResultsAt 72 months, mean (standard deviation [SD]) IOP was reduced from 17.5 (5.7) to 13.6 (3.0) mmHg (P < 0.0001) in the KDB-phaco group and from 23.3 (5.9) to 15.1 (6.2) mmHg (P = 0.0593) in the KDB-alone group. The mean (SD) number of glaucoma medications was reduced from 1.3 (1.0) to 0.8 (0.9) (P < 0.0001) in the KDB-phaco group and from 1.2 (1.0) to 0.7 (0.8) (P = 0.3409) in the KDB-alone group. During the 72-month follow-up, surgical success was achieved in 24 of the 52 available eyes (46.2%). Four eyes underwent a glaucoma surgical reintervention by 72 months.ConclusionsExcisional goniotomy with the KDB effectively lowered the IOP (by an average of 28.0% from baseline) and maintained or further reduced glaucoma medication burdens (by an average of 30.8% from baseline) under an excellent safety profile, independent of phacoemulsification status. The procedure exhibited favorable success for up to 6 years, providing valuable insights into its long-term efficacy as a glaucoma treatment.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-024-01016-8.

PurposeTo compare the safety and efficacy of Kahook Dual Blade (KDB) versus Trabectome with cataract surgery in reducing intraocular pressure (IOP) and medications used by patients with glaucoma.MethodsRetrospective chart review comparing eyes after KDB or Trabectome with cataract surgery at 2 academic centers. Surgical success was defined as IOP <21 mmHg with ≥20% IOP reduction at post-operative month 12 (POM12). Changes in IOP, number of glaucoma medications, and adverse events were assessed.ResultsNinety eyes in the KDB group and 125 eyes in the Trabectome group were included. Mean changes in IOP at POM12 were −1.9 ± 4.9 mmHg (11.2%, P = 0.002) in the KDB group and −3.5 ± 5.5 mmHg (19.1%, P < 0.001) in the Trabectome group, without a significant difference between the groups (P = 0.20). Mean change in glaucoma medications at POM12 was −0.8 ± 1.5 in the KDB group (58%, P < 0.001) and −0.3 ± 1.3 (38%, P = 0.003) in the Trabectome group, with KDB having a greater decrease in medications (P = 0.02). The percentage of eyes achieving success was 30% for the KDB group and 54% for the Trabectome group (P = 0.01). Hyphema was the most common complication, with an incidence of 3% for the KDB group and 14% for the Trabectome group (P = 0.01).ConclusionKDB or Trabectome with cataract surgery is safe and effective at lowering IOP and medication burden, with KDB resulting in a greater reduction in medications and Trabectome more frequently achieving success with an increased incidence of hyphema. Considering the study’s limitations, the outcomes were similar.

To evaluate the effect of phacoemulsification (PE) surgery on intraocular pressure (IOP) control and morphology of filtering bleb in eyes that have previously had trabeculectomy in the long-term. This retrospective study included 98 eyes of 93 patients who had undergone trabeculectomy first and then PE surgery. The IOP, morphology of bleb, the number of glaucoma medication of each patient before PE, and 1day, 1month, 3months, 1year, 2years after PE, and at the last visit were recorded. The need for additional glaucoma medication or glaucoma surgery were noted. Surgical success was defined as 6mmHg ≤ IOP ≤ 21mm Hg at the 3rd month, 1st year, and 2nd year follow-up visit, without additional medication or surgery. Before PE the IOP was ≤ 21mmHg in all of the eyes. At the last visit, the IOP was ≤ 21mmHg in 6 eyes with fewer glaucoma medication, in 24 eyes with the same number, and in 36 eyes with more. There was an increase in the number of glaucoma medications on each visit (p<0.05). There was a statistically significant difference in bleb morphologies between before PE and each visit after PE (p<0.001). Surgical success after PE was obtained in 52 eyes, additional glaucoma medication was needed in 36 eyes, and additional surgical procedures were required in 14 eyes. Phacoemulsification surgery may increase the number of glaucoma medications and the mean IOP and also may reduce the function of bleb in eyes that underwent trabeculectomy.

Comparative Study of Silicone versus Acrylic Foldable Lens Implantation in Primary Glaucoma Triple Procedure

The purpose of this study is to examine the efficacy and safety of a commercial model of the retrobulbar shunt, anterior chamber to back of the eye (A2B), in lowering intraocular pressure (IOP) and medication requirements after the failure of all other IOP-lowering therapies, including trabeculectomy with antimetabolites and tube shunt procedures. This is a single-site, prospective, nonrandomized concept study. Patients with prior failed tube shunts, or moderate to severe glaucoma refractory to treatment, were included. All subjects underwent A2B shunt implantation. Each subject's IOP and number of medications were assessed from baseline at each time interval using paired t tests. Primary outcome measures were IOP and glaucoma medication use pre- and postoperatively. Complete success is defined as (1) IOP ≤ 21mmHg; (2) IOP reduction from baseline of ≥ 20%; (3) no reoperation for glaucoma; (4) no loss of light perception vision; (5) no chronic hypotony defined as IOP ≤ 5mmHg; and (6) no use of supplemental glaucoma medication. "Qualified success" required satisfaction of the same criteria as "complete success" but with the use of supplemental glaucoma medication at 6months. Nineteen eyes of 19 patients (mean age 39.5 ± 6.4) were followed for 6months. The mean IOP (mmHg±SEM) at 6months dropped from baseline of 35.3 ± 2.3 to 18.5 ± 1.1(- 16.8, - 47%; p < 0.0001). The mean number of glaucoma medications (±SEM) at 30, 90, and 180days decreased from a baseline of 2.4 ± 0.3 to < 0.3 at each interval (p < 0.0002). The complete and qualified success rates at 6months were 46.6% (7/15) and 66.6% (11/15), respectively. The mean number of prior incisional glaucoma surgeries was 3.2. The percent of patients that had previously failed sub-Tenon tube shunt surgeries was 79%. The A2B shunt is an effective rescue therapy in patients that have failed other IOP-lowering procedures. By shunting aqueous humor into the retrobulbar space, IOP and number of glaucoma medications required were substantially reduced for the 6-month postoperative assessment interval. The intrinsic properties of the retrobulbar space may limit the risk of fibrosis, the principal cause of bleb failure.

PurposeThe present study aimed to compare the outcomes of combined phacoemulsification and 360-degree endocyclophotocoagulation with and without goniotomy using a Kahook Dual Blade in patients with glaucoma.Patients and MethodsWe enrolled 37 patients, 21 of whom underwent combined phacoemulsification with 360-degree endocyclophotocoagulation and goniotomy using a Kahook Dual Blade (tri-modal therapy (T-MT) group). The remaining 16 patients underwent phacoemulsification with endocyclophotocoagulation (bi-modal therapy (B-MT) group). Visual acuity, intraocular pressure, and number of glaucoma medications were recorded before the study and postoperatively on the first day, at week 1, and at 1, 3, 6, 9, and 12 months. Surgical success was defined as an IOP ≤12 mmHg and ≥6 mmHg or an at least 20% reduction in IOP from baseline with (qualified success) or without medications (complete success).ResultsForty-nine eyes were included. Baseline mean IOP was 16.96±3.66 mmHg and 15.64±4.88 mmHg in the T-MT and B-MT groups (p=0.122), respectively. At the 12-month follow-up, mean IOP values were 11.44±2.15 mmHg and 12.45±1.90 mmHg (p=0.031) in the T-MT and B-MT groups, respectively. Complete success rates were 37% in the T-MT group and 31% in the B-MT group, while qualified success rates were 74% and 50%, respectively. Glaucoma medications decreased from 2.0±1.4 to 0.8±1.0 (p<0.001) in the T-MT group and from 1.5±1.3 to 1.0±1.5 in the B-MT group (p=0.032). Similar improvements in visual acuity were observed in both groups. Complications were mild and resolved without intervention.ConclusionThe tri-modal treatment is safe and may be more effective in reducing IOP and glaucoma medication requirements than bi-modal treatment.

BackgroundTo compare the efficacy and safety of gonioscopy-assisted transluminal trabeculotomy (GATT) and Kahook Dual Blade (KDB) excisional goniotomy in patients with uncontrolled juvenile open-angle glaucoma (JOAG).MethodsThirty-three patients (46 eyes) were included in this single-center, retrospective, comparative study and treated with GATT (36 eyes) or KDB goniotomy (13 eyes). Intraocular pressure (IOP), number of glaucoma medications, adverse events, and additional anti-glaucoma procedures were collected during pre- and postoperative visits. Surgical success was defined as 6 mmHg ≤ IOP ≤ 18 mmHg and ≥ 20% IOP reduction from baseline with (partial success) or without (complete success) IOP-lowering medications.ResultsThe mean ± SD preoperative IOP was 30.48 ± 12.9 mmHg and 26.08 ± 13.1 mmHg (P = 0.164) on 3.71 ± 0.46 and 3.08 ± 0.86 (P = 0.023) glaucoma medications in GATT and KDB group, respectively. At 3 months, the mean ± SD IOP was 15.48 ± 5.93 mmHg and 20.0 ± 10.8 mmHg after GATT and KDB, respectively (P = 0.072). The percentage of IOP lowering from baseline was 44.4 in the GATT group and 14.1 in the KDB group (P = 0.011). The mean reduction in medications was 2.6 ± 1.7 and 0.8 ± 1.2 three months after GATT and KDB, respectively (P < 0.001). Cumulative proportion of partial and complete success were 65.6 and 44.7% in the GATT group, 30.8 and 15.4% in the KDB group at 6 months. Additional procedures were required in 13.9% of cases after GATT and in 61.5% after KDB (P = 0.001). Patients in the GATT group with prior anti-glaucoma procedures and postoperative IOP spikes were more likely to fail, while those with complete trabeculotomy had a better prognosis.ConclusionsReduction of IOP and medications were greater after GATT in uncontrolled JOAG eyes. Whereas, more additional IOP-lowering procedures were required after KDB goniotomy.Trial registrationThis study was registered under the Chinese Clinical Trial Registry (ChiCTR2000034172, 27/06/2020).