Ocular, Visual, and Anatomical Outcomes in Eyes Requiring Incisional Intraocular Pressure-Lowering Surgery Following the 0.19-mg Fluocinolone Acetonide Intravitreal Implant.

BACKGROUND AND OBJECTIVE: To assess ocular, visual, and anatomical outcomes following the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) and incisional intraocular pressure (IOP)-lowering surgery in diabetic macular edema. PATIENTS AND METHODS: From a 36-month, phase 4, open-label, observational study (N = 202 eyes, 159 patients), 8 eyes (7 patients) required IOP-lowering surgery post-FAc; eyes were segregated by FAc-induced (n = 5, 2.47%) versus neovascular glaucoma (NVG)-related (n = 3, 1.49%) IOP elevations and assessed for IOP, best corrected visual acuity (BCVA), central subfield thickness (CST), and cup-to-disc ratio (c/d). RESULTS: Changes at 36 months were +5.4 letters BCVA (P > 0.05) and +0.09 c/d (P = 0.0217); IOP and CST were unchanged. FAc-induced-group eyes required fewer IOP-lowering medications than NVG-group eyes (2.0 versus 4.0; P < 0.01) but for longer duration (15.2 versus 2.6 months; P < 0.001). CONCLUSIONS: Post-FAc IOP-lowering surgery, regardless of cause, largely did not affect the outcomes measured; these procedures, then, may not meaningfully threaten positive outcomes. [Ophthalmic Surg Lasers Imaging Retina 2024;55:22-29.].

The 0.19-mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: Intraocular Pressure-Related Effects over 36 Months.

PURPOSE: To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME). DESIGN: Secondary analysis of a 36-month, phase IV, nonrandomized, open-label, observational study. PARTICIPANTS: The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication. METHODS: Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant. RESULTS: Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan-Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable. CONCLUSIONS: Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Challenging the "Topical Medications-First" Approach to Glaucoma: A Treatment Paradigm in Evolution.

Topical glaucoma medications are effective and safe, but they have numerous well-documented limitations that diminish their long-term utility and sustainability. These limitations can include high rates of nonadherence (with associated glaucoma progression), concerning side effects, inconsistent circadian intraocular pressure (IOP) control, complex dosing regimens, difficulty with self-administration, costs, and decreased quality of life. Despite these limitations, topical medications traditionally have been first-line in the glaucoma treatment algorithm, as no other minimally invasive treatment alternatives existed. In recent years, however, novel interventional therapies-including sustained-release drug-delivery platforms, selective laser trabeculoplasty, and micro-invasive glaucoma surgery procedures-have made it possible to intervene earlier without relying on topical medications. As a result, the topical medication-first treatment approach is being reevaluated in an overall shift toward earlier more proactive interventions.

Optic disc cupping after circumpapillary Pd-103 slotted plaque radiation therapy.

OBJECTIVE: To investigate vascular and morphologic optic disc changes after slotted plaque radiation therapy for choroidal melanoma involving the optic disc. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: Thirty-nine patients with choroidal melanoma involving the optic nerve. METHODS: Each melanoma was treated with palladium-103 slotted plaque brachytherapy (incorporating and/or surrounding the optic nerve sheath) between 2005 and 2019. Imaging of the optic nerve before and after radiation allowed for documentation and evaluation of optic nerve pallor and cup-to-disc ratio (CDR) changes. Optical coherence tomography (OCT) CDR measurements and intraocular pressure (IOP) were recorded pretreatment and at follow-up. Of these patients, 22 also had OCT angiography (OCT-A) images with sufficient quality for evaluation of blood vessel density and length. Differences in cup-to-disc measurements were correlated with changes in OCT-A-measured vessel density and length. RESULTS: Following slotted plaque radiation therapy, there was no significant increase in IOP or optic nerve pallor. OCT and colour photography revealed significant increases (both p < 0.001) in CDR from pretreatment to the last follow-up. Increased CDRs on OCT were significantly correlated to OCT-A-measured change in vessel length (p = 0.027). Similarly, increased CDR ratios on fundus photography were significantly correlated with OCT-A-measured change in vessel density (p = 0.043) and length (p = 0.019). CONCLUSION: Fundus photography and OCT measurements revealed increased optic disc cupping following slotted plaque radiation therapy. Cupping was associated with OCT-A evidence of synchronous progressive peripapillary vascular occlusion and attenuation. Therefore, slotted plaque radiation-induced peripapillary and papillary ischemia was associated with increased CDR ratios and optic disc cupping.

A Review of Excisional Goniotomy Performed with the Kahook Dual Blade for Glaucoma Management.

Aim: To review the published literature describing clinical outcomes of excisional goniotomy using the Kahook Dual Blade (KDB) for the management of glaucoma. Background: A family of less invasive glaucoma procedures-including excisional goniotomy with the KDB-has been developed to provide moderate reductions in intraocular pressure and/or medication burden in eyes with therapeutic needs that may not warrant the risks associated with more traditional procedures such as trabeculectomy and tube-shunt implantation. This review's goal is to synthesize the existing literature into a compendium of excisional goniotomy's indications, technique, efficacy and safety outcomes, and optimal place in glaucoma management. Review results: Excisional goniotomy with the KDB effectively lowers IOP and reduces the medication burden in eyes with POAG and other forms of glaucoma across the spectrum of both baseline IOP and disease severity. The procedure exhibits a safety profile that is on par with other angle-based surgical interventions and enhanced safety compared to filtration procedures. It can be performed by comprehensive ophthalmologists as well as glaucoma specialists. This procedure as a standalone operation delivers IOP reductions consistent with filtration surgery, and in combination with cataract surgery delivers both IOP and medication reductions at least as great as other minimally invasive procedures. Conclusion: Given the broad base of evidence supporting its use in a wide variety of clinical scenarios, excisional goniotomy with the KDB can play a meaningful role in the achievement of patient-specific glaucoma therapy goals. Clinical significance: These aggregate findings support the efficacy and safety of excisional goniotomy with the KDB and clarify the patient profiles best suited for this procedure. How to cite this article: Dorairaj S, Radcliffe NM, Grover DS, et al. A Review of Excisional Goniotomy Performed with the Kahook Dual Blade for Glaucoma Management. J Curr Glaucoma Pract 2022;16(1):59-64.

Outcomes of Sutureless Ahmed Glaucoma Valve Surgery: A Retrospective Study.

INTRODUCTION: This study compared the safety and efficacy of sutureless Ahmed glaucoma valve surgery (AGV standalone) to sutureless AGV plus cataract surgery (AGV-CEIOL) in Black or Hispanic patients. METHODS: Records from Black or non-white Hispanic patients who received either AGV standalone or AGV-CEIOL from 2014 to 2019 at a Bronx, New York practice were reviewed. All surgeries were performed using a sutureless technique with Tisseel fibrin glue. Primary outcomes included failure (defined as intraocular pressure (IOP) > 21 mmHg, ≤ 5 mmHg, or reduced by < 20% after the first 3 months; loss of light perception; or reoperation for glaucoma), hypertensive phase, IOP changes, and medication changes. Secondary outcomes included postoperative complications and interventions. RESULTS: A total of 203 eyes that received AGV standalone (n = 78) or AGV-CEIOL (n = 125) were analyzed. Mean follow-up duration was 42.2 ± 17.5 months, with similar cohort-specific intervals (P = 0.68). Failure among AGV-CEIOLs (44.8%, n = 56) and AGV standalones (47.4%, n = 37) occurred at similar frequencies; log-rank testing indicated comparable 5-year survival (P = 0.56). Mean IOP among AGV-CEIOLs (15.8 ± 12.1 mmHg) was greater than standalones (8.6 ± 5.1 mmHg) at post-op day 1 (P < 0.001). The AGV-CEIOL group had a 60% lower odds of experiencing a hypertensive phase after adjustment for baseline group differences (P = 0.01). Five-year IOP reduction was similar between groups in the multivariable model (P = 0.45). There were no significant differences in medications (P > 0.05 at all time points) or in total complications (P = 0.28). More standalones required reoperation (39.7%, n = 31) compared to AGV-CEIOLs (21.6%, n = 24; P = 0.007). CONCLUSIONS: Sutureless AGV-CEIOL was noninferior to sutureless AGV standalone when performed in Black or non-white Hispanic patients. The combined group experienced the hypertensive phase less frequently despite higher day 1 IOP.

Factors associated with vision loss in Black or Hispanic patients 1 year after standalone or combined Ahmed glaucoma valve surgery.

PURPOSE: To determine factors associated with vision loss 1 year after Ahmed glaucoma valve (AGV) surgery in Black or Hispanic patients, who bear disproportionate glaucoma burdens yet have been underrepresented in pivotal trials. METHODS: This retrospective study included Black or Hispanic patients who received AGVs standalone or combined with phacoemulsification and/or cyclodestructive lasers. Univariate and multivariate generalized estimating equations evaluated the effects of baseline, surgical, and postoperative factors on vision loss of two Snellen lines or more at the 1-year follow-up visit. The primary term was the hypertensive phase (HP), which signified an intraocular pressure (IOP) reading > 21 mmHg within the first 3 postoperative months after reduction below 22 in the first week, without other tube malfunction. RESULTS: Of 241 eyes from 186 patients, vision loss of ≥ 2 lines at the 1-year follow-up visit occurred in 21.6% (N = 52). Vision loss of ≥ 2 lines occurred in 52.5% of eyes at week 1, 36.9% of eyes at month 1, and 27.0% of eyes at month 3. Between 6 months and 1 year, vision loss frequencies stabilized. In the multivariate model, HP (OR = 4.71 (2.14, 10.38)), total quadrants with split fixation (1.47 (1.20, 1.81)), follow-up non-glaucomatous eye pathology (2.89 (1.44, 5.80)), and concurrent cataract surgery (0.42 (0.22, 0.82)) each met significance (p < 0.05). CONCLUSION: Post-AGV vision loss in the early follow-up period among Black or Hispanic patients was often transient. Hypertensive phase and split fixation each increased the odds of vision loss at 1 year, while concurrent cataract surgery decreased the odds.

Comparison of Safety and Efficacy Between Ab Interno and Ab Externo Approaches to XEN Gel Stent Placement.

PURPOSE: To compare the safety and efficacy of two different techniques for implantation of the XEN Gel Stent, a minimally invasive surgical device for the treatment of refractory glaucoma. METHODS: A retrospective chart review of eyes that received ab interno or ab externo XEN Gel Stent placement from February 2017 to October 2019 was conducted. A single surgeon (NMR) performed all operations. Eyes that received the XEN implant concomitant with a glaucoma drainage device insertion or that were lost to 6-month follow-up were excluded. Intraocular pressure (IOP) change, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes compared between groups. RESULTS: Fifty eyes that underwent ab interno placement and 30 eyes that underwent ab externo placement were studied. The ab interno cohort demonstrated a mean IOP reduction of 8.4 ± 1.7 mmHg (28.6% decrease) by 12 months, compared to a mean reduction of 12.8 ± 3.0 mmHg (40.1% decrease) in the ab externo group (p = 0.208). Mean reduction in medication use was 1.81 ± 0.29 medications in the ab interno group and 1.86 ± 0.37 in the ab externo group (p = 0.913). By 12 months, 58% of ab interno eyes had required 5-fluorouracil injection compared to 36.7% of ab externos (p = 0.105). Bleb needling was applied to 42% and 26.7% of the eyes, respectively (p = 0.231). A second glaucoma surgery was necessary for 20% of the ab interno cohort and 10% of the ab externo cohort (p = 0.351). CONCLUSION: There were no differences in outcomes between ab interno and ab externo placement of the XEN Gel Stent. Both approaches are safe and effective for lowering IOP.

The association between corneal hysteresis and surgical outcomes from trabecular meshwork microinvasive glaucoma surgery.

PURPOSE: To assess whether an association exists between pretreatment corneal hysteresis (CH) and the magnitude of intraocular pressure (IOP) and medication burden reduction following microinvasive glaucoma surgery (MIGS). METHODS: Retrospective chart review of 84 eyes from 57 patients with CH measurements who underwent trabecular meshwork MIGS in a glaucoma practice in New York City with follow-up visits at 3-6 and 9-12 months. MIGS included canaloplasty, goniotomy, microbypass stents, or a combination thereof. RESULTS: The lowest and middle CH tertiles experienced significantly reduced mean IOP at 3-6-month follow-ups (p = .007, < .001), whereas the highest tertile did not (p = .06). At 9-12-month follow-ups, a significant mean IOP reduction only persisted in the middle tertile (p = .001). For medication burden reduction, only the highest CH tertile experienced significant mean reductions at both 3-6- and 9-12-month follow-ups (p = .015, .028). Notably, 7 patients in the lowest CH tertile failed MIGS and required an additional surgical or laser procedure within 24 months of MIGS, whereas only 3 patients failed in the other tertiles (likelihood ratio < .05). Multivariate analysis excluding MIGS failures demonstrated an inverse association between CH and the magnitude of post-operative IOP reduction at both 3-6- and 9-12-month follow-ups when controlling for baseline IOP and medication changes (p = .002, .026). CONCLUSION: There was an inverse association between pretreatment CH and the magnitude of IOP reduction following surgery. There is also evidence of an increased need for repeat surgery or other intervention in patients with lower CH who undergo MIGS.

Digital Survey Assessment of Factors Associated with Musculoskeletal Complaints Among US Ophthalmologists.

PURPOSE: To quantify features of musculoskeletal (MSK) complaints among US ophthalmologists and analyze factors related to symptom severity. METHODS: Cornea, glaucoma, retina, and comprehensive practitioners were invited to complete a web-based survey via email. Data on demographics, practice and procedural volumes, wellness activities, job stress, MSK health, the Total Disability Index (TDI), and ergonomics were collected. Significance testing was performed to evaluate factors related to TDI score. RESULTS: Of the 245 ophthalmologists contacted, 58.8% (n = 144) responded at least in part to the survey. Pain episodes were reported in 81.4% (n = 83) of 102 respondents, with 48.1% (n = 49) experiencing daily or weekly attacks. The neck, low back, and shoulders were commonly affected, yet only 57.1% (n=20) of those with shoulder pain reported a corresponding diagnosis. The mean TDI score was 6.2 ± 7.3%, indicating minimal disability related to the spine. Demographics, volume metrics, and wellness hours were each not significantly associated with TDI score (p > 0.05). Higher job stress ratings were reported by those who experienced more frequent pain attacks (p = 0.02) and those with higher TDI scores (p = 0.001). Greater difficulty with clinic, laser, and surgery job tasks was observed in respondents with higher TDI scores (p < 0.001, p = 0.005, and p < 0.001) and more bodily pain locations (p = 0.002, p = 0.002, and p = 0.001). Respondents who pursued practice modifications (p = 0.03) and treatments (p = 0.01) to reduce or prevent pain had higher mean TDI scores, and 94.2% of respondents (n = 97) were interested in learning more about ergonomics. CONCLUSION: Mild MSK complaints were highly prevalent among the surveyed ophthalmologists, and a similar trend could be expected for other US ophthalmologists. Greater frequency and severity of pain may contribute to physician burnout. There may be underdiagnosis of MSK pathology yet also high demand for ergonomic strategies and MSK treatments, suggesting a need for practical solutions.

Evaluation of the IOP-Lowering Effect of a Multi-Pressure Dial at Different Negative Pressure Settings.

Purpose: To evaluate the intraocular pressure (IOP)-lowering effect of a multi-pressure dial (MPD) at targeted negative pressure settings. Methods: Prospective, intrasubject controlled study of 65 healthy subjects randomized to receive no negative pressure for 60 minutes or negative pressure application at designated levels of 25%, 50%, and 75% of baseline IOP for 20 minutes each. The main outcome measure was mean IOP with application of negative pressure. Results: In the study eye group, from a baseline IOP of 15.8 ± 3.6 mm Hg, the mean IOP was 13.5 ± 3.4, 11.5 ± 3.1, and 10.2 ± 2.7 mm Hg with negative pressure settings of 25%, 50% and 75%, respectively. In the control eye group, from a baseline IOP of 15.5 ± 3.0 mm Hg, the mean IOP values at the same time points, without negative pressure, were 15.6 ± 3.0, 15.5 ± 2.5 and 15.3 ± 2.4 mm Hg. The difference between the mean IOPs of the two groups was significantly different at all negative pressure settings (P < 0.001) in comparison with baseline. There was one minor adverse event, a corneal abrasion, that was unrelated to device wear. Conclusions: Negative pressure application to the periocular space with a multi-pressure dial can produce titratable IOP reduction while the device is worn with active negative pressure. To our knowledge, this technology represents the first nonpharmacologic, nonlaser, nonsurgical method for IOP reduction. Translational Relevance: This represents the first study demonstrating the IOP-lowering ability of the multi-pressure dial, a device that uses a novel IOP-lowering strategy by delivering negative pressure to the periocular region.

Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study.

PURPOSE: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days. DESIGN: Prospective, open-label, randomized, single-site study. SUBJECTS: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days. METHODS: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period. RESULTS: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable. CONCLUSION: The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.

Circumferential Viscodilation Ab Interno Combined with Phacoemulsification for Treatment of Open-Angle Glaucoma: 12-Month Outcomes.

PURPOSE: To evaluate reduction in intraocular pressure (IOP) and medications for open-angle glaucoma (OAG) patients 12 months post-ab-interno circumferential viscodilation (VISCO360, Sight Sciences, Menlo Park, CA) in conjunction with cataract surgery. SETTING: Surgical center (New York, United States). DESIGN: Retrospective study of all OAG patients treated with 360-degree ab-interno viscodilation with cataract surgery by a single surgeon (NR) having 12 months of follow-up. Eyes were stratified by baseline IOP. Group 1: ≥18 mmHg (n=111). Group 2: <18 mmHg (n=69). METHODS: IOP was measured using Goldmann applanation tonometry. Medications, the number of medication-free eyes in each group at 12 months, and adverse events (AE) are reported. Analysis includes descriptive statistics and t-tests evaluating change from baseline. RESULTS: Groups 1 and 2 had mean baseline IOP of 22 and 14.3 mmHg. Medication use was 0.9 and 1.1 for Groups 1 and 2. At 12 months IOP for Group 1 was reduced 22% to 17.2 mmHg (p<0.0001) on 1.0 medications (p=0.7). IOP for Group 2 was similar to baseline (15.4 mmHg) but with a reduction in medications to 0.6 (p<0.05). The proportion medication free at 12 months was 32% and 47% for Groups 1 and 2 versus 34% and 26% at baseline, respectively. There were few AE (hyphema 1.7%, IOP elevation >10 mmHg >30 days post-op 1.1%, mild inflammation <1%) and no secondary surgical interventions excepting a single paracentesis, one-day postoperative. DISCUSSION: Treatment goals for the two groups differed. Pressure reduction (Group 1) or medication reduction (Group 2). Viscodilation achieved significant IOP reduction in Group 1 and medication reduction in Group 2 with many patients (both groups) medication free at 12 months. AE were infrequent and transient. CONCLUSION: Circumferential ab-interno viscodilation can be combined with cataract surgery and provide an IOP lowering and medication reduction benefit sustained for at least 12 months, for many patients with OAG.

Relationship between optic disc hemorrhage and corneal hysteresis.

OBJECTIVE: To determine the relationship between optic disc hemorrhage (DH) and corneal hysteresis (CH). METHODS: Consecutive patients with prior or current photographic evidence of unilateral DH who had undergone CH measurement with the Ocular Response Analyzer (ORA; Reichert, Buffalo, NY) were enrolled. Eyes with a history of corneal disease, refractive surgery, or bilateral DH were excluded. Central corneal thickness (CCT), visual field data, 5 consecutive previous intraocular pressures (IOPs), and maximum documented peak IOP were obtained by chart review. Vertical cup-to-disc ratio (VCDR), the presence of neuroretinal rim notching, number of clock hours of beta zone parapapillary atrophy (ßPPA), and eye with greater ßPPA width were determined from photographs by 2 masked expert examiners. RESULTS: We identified and analyzed 49 patients with photographically documented unilateral DH. Compared to fellow non-DH eyes, eyes with DH had lower CH (8.7 ± 1.9 vs 9.2 ± 1.7; p = 0.002), higher IOP (15.6 ± 3.6 vs 14.3 ± 4.1; p = 0.017), and greater VCDR (0.79 ± 0.13 vs 0.68 ± 0.23; p < 0.001), but were similar with respect to CCT, ßPPA extent, rim notching, peak IOP, and visual field damage (all p > 0.05). Using multivariate conditional logistic regression analysis, only CH (p = 0.012) and VCDR (p = 0.004) predicted the laterality of the DH. CONCLUSIONS: Lower CH and greater VCDR are independently associated with DH. This suggests that CH may be a structural biomarker for an abnormality of the optic nerve complex that may be associated with progressive glaucoma. Eyes in which DH were detected had lower CH.

8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study.

PURPOSE: To investigate the safety and tolerability of the multi-pressure dial with a continuous 8-hr duration in subjects with open-angle glaucoma. DESIGN: Prospective, controlled open-label, randomized, single site study. SUBJECTS: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with a multi-pressure dial and randomized to negative pressure application of -10 mmHg in one eye for 8 (continuous) hours and ambient atmospheric pressure in the contralateral eye. METHODS: Main safety outcome measures include best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were administered both hourly during the 8-hr study period and immediately following the study period. RESULTS: There were no statistically significant changes in IOP, BCVA or TBUT immediately following the 8-hr study period or at the 1-week follow-up visit. Patient-reported tolerability was favorable with a mean response of 1.8 ± 0.4 (scale → 1=best, 10 = worst). Subjects also reported positive interest in the MPD as a glaucoma therapy with a mean response of 1.8 ± 0.5 (scale → 1=best, 10 = worst). One adverse event was reported (headache) and resolved at conclusion of the Day 0 visit. CONCLUSION: The MPD demonstrated favorable safety with key parameters remaining stable after an 8-hr wear with negative pressure. Negative pressure application through the MPD was well tolerated by subjects enrolled in the study. The favorable findings demonstrate the safety of sustained delivery of negative pressure over a continuous, uninterrupted 8-hr duration.

Surgical outcomes associated with a sutureless drainage valve implantation procedure in patients with refractory glaucoma.

PURPOSE: To evaluate the safety and efficacy profile of a sutureless procedure for drainage valve implantation with combined cataract removal and/or endoscopic cyclophotocoagulation (ECP). MATERIALS AND METHODS: A retrospective case series study of consecutive surgeries for Ahmed glaucoma valve (AGV; New World Medical) implantation in a 1-year period was analyzed. The surgery was performed using a Tisseel fibrin sealant (Baxter Healthcare Corporation) in place of sutures. Some subsets within the case series also included a cataract extraction with intraocular lens (CEIOL) insertion and/or ECP (Endo Optiks) within the same procedure. Primary outcomes for this study including efficacy (IOP change, reduction in medications) and safety (complications and reoperations) were measured out to 3 years. Comparisons between subsets were made using ANOVA with post hoc Tukey's pairwise tests. RESULTS: One hundred twenty-two eyes of 99 patients underwent sutureless AGV implantation surgery. Of the 122, 18 had an AGV implantation only, 46 had an AGV + CEIOL, 35 had an AGV + ECP, and 23 had an AGV + CEIOL + ECP. In total, there was a significant decrease in IOP (P<0.0001) and number of glaucoma medications (P≤0.0054) at each postoperative visit. In a one-way ANOVA, there were no significant differences in mean IOP between the different subsets of surgeries (P>0.05); 10.7% and 14.8% of eyes required a reoperation either for a complication or for uncontrolled glaucoma, respectively. CONCLUSION: Sutureless valve implantation is associated with a significant reduction in IOP percentage and medication use after the procedure with a safety profile comparable with other glaucoma surgeries.

12-Month Outcomes of Goniotomy Performed Using the Kahook Dual Blade Combined with Cataract Surgery in Eyes with Medically Treated Glaucoma.

INTRODUCTION: To describe the 12-month efficacy and safety of goniotomy performed using the Kahook Dual Blade (KDB) in combination with cataract surgery in eyes with medically treated open-angle glaucoma (OAG). METHODS: This was a prospective, interventional case series conducted at seven centers in North America. Consecutive patients with medically treated OAG and visually significant cataract underwent phacoemulsification combined with goniotomy (PE + goniotomy) using KDB. Indications for glaucoma surgery included reduction of intraocular pressure (IOP) and reduction of IOP-lowering medications. De-identified data were collected and included pre-, intra-, and postoperative data on IOP, the use of IOP-lowering medications, and adverse events through 12 months of follow-up. RESULTS: Among 52 eyes undergoing surgery, mean IOP was reduced from 16.8 ± 0.6 mmHg at baseline to 12.4 ± 0.3 mmHg at month 12 (P < 0.001), a 26.2% reduction. Mean IOP across time points ranged from 12.4-13.3 mmHg during follow-up. The mean number of topical IOP-lowering medications was reduced from 1.6 ± 0.2 at baseline to 0.8 ± 0.1 at month 12 (P < 0.05), a 50.0% reduction. At month 12, 57.7% of eyes had IOP reduction ≥ 20% from baseline, and 63.5% were on ≥ 1 fewer IOP-lowering medications. In subgroup analysis, 84.6% of eyes with lower mean baseline IOP were using ≥ 1 fewer medications at month 12, and 100% of eyes with higher mean baseline IOP had IOP reductions ≥ 20%. The most common postoperative adverse events were pain/irritation (n = 4, 7.7%), opacification of the posterior lens capsule (n = 2, 3.8%), and IOP spike > 10 mmHg (n = 2, 3.8%). CONCLUSION: PE + goniotomy using the KDB significantly lowers both IOP and dependence on IOP-lowering medications in eyes with OAG. Adverse events were not sight-threatening and typically resolved spontaneously. FUNDING: New World Medical, Inc.

Goniotomy with a single-use dual blade: Short-term results.

PURPOSE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of a single-use dual blade (Kahook) in patients with mild to end-stage glaucoma. SETTING: International multicenter ophthalmic care centers. DESIGN: Prospective interventional case series. METHODS: Consecutive patients with glaucoma who had phacoemulsification plus goniotomy with the single-use dual blade were enrolled in this study. Each center collected deidentified clinical data, including preoperative and postoperative IOP, medication use, adverse events, and whether additional surgery was required during a 6-month follow-up. RESULTS: Of the 71 eyes included in this study, 70% had primary open-angle glaucoma. Other diagnoses included angle-closure, pigmentary, pseudoexfoliative, and normal-tension glaucoma. Sixty-five percent of eyes were classified as having mild to moderate glaucoma and 35%, severe glaucoma. The mean baseline IOP decreased from 17.4 mm Hg ± 5.2 (SD) to 12.8 ± 2.6 mm Hg 6 months postoperatively and the hypotensive medication use decreased from 1.6 ± 1.3 to 0.9 ± 1.0, respectively (P < .001 and P = .005, respectively). The most common observation was blood reflux during surgery (39.4%). CONCLUSION: Single-use dual blade goniotomy plus phacoemulsification resulted in a significant and sustained reduction in IOP and a decrease in glaucoma medications after 6 months of follow-up.