Supplemental Intravitreal Ranibizumab Injections in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial.

PURPOSE: To determine the proportion and characteristics of eyes with neovascular age-related macular degeneration (nAMD) treated with the Port Delivery System with ranibizumab (PDS) that receive supplemental intravitreal ranibizumab injections due to changes in best-corrected visual acuity (BCVA) and/or central subfield thickness (CST), and to investigate the safety and efficacy of supplemental injections in eyes with the PDS. DESIGN: Post-hoc analyses of data from the phase 3, randomized, multicenter, open-label, active-comparator Archway trial (NCT03677934). PARTICIPANTS: Adults with nAMD diagnosed within 9 months of screening previously responsive to anti-vascular endothelial growth factor (anti-VEGF) therapy. INTERVENTION: 418 patients were randomized to the PDS with ranibizumab 100 mg/mL with fixed refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab 0.5 mg for 96 weeks. RESULTS: Of the 246 eyes treated with the PDS Q24W and assessed for supplemental treatment criteria, the vast majority (94.6%-98.4%) did not receive supplemental treatment during each retreatment interval, with 87.4% not receiving supplemental treatment at any point during the trial. Of the 31 eyes receiving supplemental treatment, 58.1% received 1 injection and 32.3% received 2. At baseline, eyes receiving supplemental treatment were significantly more likely to have thicker retinas (mean CST 370.5µm vs 304.4µm; P = 0.0001), subretinal fluid (54.8% vs 21.2%; P < 0.0001), and larger pigment epithelial detachment height (215.7µm versus 175.9µm; P = 0.003). These features have previously been associated with difficult-to-treat nAMD. Whereas BCVA and CST generally remained constant throughout the trial in eyes without supplemental treatment, the small number of eyes receiving supplemental treatment on average lost 1 line of vision from baseline to week 96 (mean -5.7 Early Treatment Diabetic Retinopathy Study score letters) and CST continued to increase over time. Absolute BCVA at week 96 was similar irrespective of supplemental treatment status (71.1 and 73.7 letters). BCVA and CST generally improved within 28 days of supplemental treatment. CONCLUSIONS: Although the PDS Q24W effectively maintains vision and retinal stability in most eyes with nAMD, a small proportion of patients with features of difficult-to-treat nAMD may benefit from supplemental intravitreal anti-VEGF injections and initial close monitoring is recommended.

The Association of Retinal Disease with Vision Impairment and Functional Status in Medicare Patients.

Background: The association of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) with functional status in the general Medicare population are not well established. Objectives: This study examined patient-reported survey data linked with Medicare claims to describe the burden of these vision-threatening retinal diseases (VTRDs) among Medicare beneficiaries. Methods: Medicare Current Beneficiary Survey data linked with Medicare Fee-for-Service claims data from 2006 to 2018 were used in a nationally representative retrospective pooled cross-sectional population-based comparison study. Outcomes between community-dwelling beneficiaries with nAMD (n = 1228), DME (n = 101), or RVO (n = 251) were compared with community-dwelling beneficiaries without any VTRDs (n = 104 088), controlling for baseline demographic and clinical differences. Beneficiaries with a diagnosis of nAMD, DME, or RVO during the data year were included; those with other VTRDs were excluded. Outcomes included vision function and loss, overall functioning as assessed by difficulties with activities of daily living (ADLs) and instrumental ADLs (iADLs), anxiety/depression, falls, and fractures. Results: In patient cohorts with nAMD, DME, and RVO, approximately one-third (34.2%-38.3%) reported "a little trouble seeing" (vs 28.3% for controls), and 26%, 17%, and 9%, respectively, reported "a lot of trouble seeing/blindness" (vs 5% of controls). Difficulty walking and doing heavy housework were the most reported ADLs and iADLs, respectively. Compared with those without VTRDs, beneficiaries with nAMD had higher odds of diagnosed vision loss (odds ratio [OR], 5.39; 95% confidence interval, 4.06-7.16; P < .001) and difficulties with iADLs (odds ratio, 1.41; 95% confidence interval, 1.11-1.80; P = .005); no differences were observed for DME or RVO vs control. After adjusting for age, sex, race/ethnicity, poverty status, comorbidities, and other relevant covariates, nAMD, DME, and RVO were not significantly associated with anxiety/depression, falls, or fractures. Discussion: Patients with nAMD or DME were more likely to report severe visual impairment than those without VTRDs, although only those with nAMD were more likely to be diagnosed with vision loss. Conclusions: Patients with nAMD continue to experience more vision impairment and worse functional status compared with a similar population of Medicare beneficiaries despite availability of therapies like antivascular endothelial growth factor to treat retinal disease.

Impact of Anti-VEGF Treatment and Patient Characteristics on Vision Outcomes in Neovascular Age-related Macular Degeneration: Up to 6-Year Analysis of the AAO IRIS® Registry.

Purpose: To evaluate anti-VEGF treatment patterns and the influence of patient demographic and clinical characteristics on up to 6-year vision outcomes in neovascular age-related macular degeneration. Design: Retrospective, multicenter, noninterventional registry study with up to 6 years of follow-up. Participants: A cohort of 254 655 eyes (226 767 patients) with first anti-VEGF injection and at least 2 years of follow-up; 160 423 eyes had visual acuity (VA) data. Methods: Anonymized patient data were collected in the United States through the IRIS® Registry (Intelligent Research in Sight). Main Outcome Measures: Changes in VA from baseline; frequency of and gaps between intravitreal anti-VEGF injections; treatment discontinuations; switching anti-VEGF agents; and influence of baseline clinical and demographic characteristics on VA. Results: After a mean VA increase of 3.0 ETDRS letters at year 1, annual decreases led to a net loss from baseline of 4.6 letters after 6 years. Patients with longer follow-ups had better baseline and follow-up VA. From a mean of 7.2 in year 1 and 5.6 in year 2, mean injections plateaued between 4.2 to 4.6 in years 3 through 6. Treatment was discontinued in 38.8% of eyes and switched in 32.3%. When adjusting for differences at baseline, every additional injection resulted in a 0.68 letter improvement from baseline to year 1; thus, multiple injections in a year have the potential to be clinically meaningful. Older age, male gender, Medicaid insurance, and not being treated by a retina specialist were associated with a higher likelihood of vision loss at year 1. Of the patients, 58.5% lost ≥ 10 letters VA at least once during follow-up, with 14.5% of patients experiencing sustained poor vision after a median of 3.4 years. Conclusions: After modest mean VA improvement with intravitreal anti-VEGF injections at year 1, patients netted a loss of VA by year 6. Injection frequency decreased over time, and this was paired with a relatively high rate of discontinuation. Modeling suggested that more frequent injections were associated with better VA. Difficulty with continuous adherence to frequent intravitreal injections may have contributed to undertreatment resulting in less-than-optimal vision outcomes. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Maintenance of Vision Needed to Drive after Intravitreal Anti-VEGF Therapy in Patients with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema.

OBJECTIVE: To evaluate the association between intravitreal anti-VEGF therapy and visual acuity (VA)/driving vision maintenance over 4 years in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). DESIGN: Retrospective, observational, clinical practice cohort study using data from the Vestrum Health database. PARTICIPANTS: Initial diagnosis (January 1, 2014 to June 30, 2019) of nAMD or DME and ≥ 1 year of treatment/follow-up history. The VA analysis required 4 years of treatment/follow-up history. For the driving vision maintenance analysis, patients required Snellen VA of 20/40 or better at baseline and for ≥ 6 months during year 1 after index intravitreal anti-VEGF treatment in the better-seeing eye. METHODS: A loss-of-driving event was the first clinic visit with VA worse than 20/40 sustained for ≥ 6 consecutive months. Kaplan-Meier analyses estimated the probability of maintaining driving vision over 4 years stratified by year-1 injection number. Cox proportional hazard models examined associations between baseline clinical characteristics and year-1 injection frequency and the risk of losing driving vision. MAIN OUTCOME MEASURES: Mean change in VA over time and by baseline VA, driving vision maintenance probability over time and stratified by anti-VEGF injection frequency, and baseline factors predictive of driving vision maintenance. RESULTS: In year 1, the nAMD and DME cohorts gained 8.5 and 9.5 ETDRS letters, respectively. Between years 1 and 4, patients with nAMD and DME lost 6.6 and 2.7 ETDRS letters, respectively. The probability of maintaining driving vision over 4 years was 56% (nAMD) and 72% (DME); among patients who received 1 to 5, 6 to 7, and ≥ 8 anti-VEGF injections in year 1, corresponding probabilities were 50%, 56%, and 65% (nAMD; P < 0.001) and 63%, 72%, and 77% (DME; P < 0.001). Baseline factors associated with driving vision loss included older age, worse index VA, geographic atrophy (nAMD), and worsening baseline diabetic retinopathy (DME). CONCLUSIONS: Older age and worse index VA were risk factors for driving vision loss, whereas a greater year-1 injection number was associated with driving vision maintenance through year 4, supporting early initiation and frequent anti-VEGF injections for maintaining driving vision in nAMD or DME. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Modified Split-Thickness Corneal Patch Graft for Conjunctival Erosions in Patients With the Port Delivery System Implant: Surgical Technique and Long-Term Outcomes.

Purpose: To describe the surgical technique and long-term outcomes of a modified split-thickness corneal patch grafting for conjunctival erosions that can be seen in patients with the Port Delivery System (PDS) implant. Methods: By way of retrospective review of medical records, this interventional case series identified 2 cases in which modified split-thickness corneal patch grafting was used to repair conjunctival erosion in patients with the PDS implant. Results: The surgical approach involved creating a small opening in the corneal graft over the center of the PDS implant to improve visibility and allow for easier access during subsequent refill-exchange procedures. At the last follow-up of 6.9 years and 5.6 years, there was no recurrence of conjunctival erosions in either patient. The PDS implants remained well covered with the split-thickness corneal graft and had undergone multiple implant refills without complication or difficulty. Conclusions: Modified split-thickness corneal patch grafting with central graft aperture offers another option for long-term successful management of conjunctival erosions in patients with a PDS, especially those who have failed prior repair, by allowing sufficient visibility and access for subsequent refill-exchange procedures.

Conjunctiva and Tenon's Capsule Handling in the Port Delivery System with Ranibizumab Implant Insertion Procedure: Surgical Pearls.

OBJECTIVES: To describe conjunctiva and Tenon's capsule handling during the Port Delivery System with ranibizumab (PDS) implant insertion procedure including up-front assessments, planning, and instrumentation, with emphasis placed on the peritomy, scleral dissection, and closure steps. METHODS: Surgical pearls based on experience accumulated in the PDS clinical trial program in patients with retinal diseases. RESULTS: Preoperative preparation, specific instruments, and meticulous techniques are key to optimizing surgical outcomes. Before surgery, assessment of factors that affect conjunctival integrity and an in-office conjunctiva examination are conducted. Gentle, purposeful conjunctiva and Tenon's capsule handling with nontoothed forceps and suturing with a BV needle are recommended to prevent tissue damage. The peritomy is 6 mm by 6 mm, centered around the planned implant location in the superotemporal quadrant. A complete sub-Tenon's capsule dissection is achieved using a wide, robust lateral and posterior dissection technique to free tissue from the sclera and minimize tension. The globe is stabilized during scleral cutdown by grasping the sclera with fine-toothed forceps away from the incision edge to prevent tissue delamination. When closing the peritomy, both the conjunctiva and Tenon's capsule are completely captured and sutured with scleral anchoring at the apex of the peritomy to help prevent conjunctival retraction and erosion. Mitigation and detection of adverse events is critical to successful surgical outcomes. CONCLUSIONS: The PDS implant insertion procedure is straightforward, but it requires planned preoperative preparation, specific instruments, and meticulous techniques. The surgical pearls described here offer insights for optimizing outcomes. [Ophthalmic Surg Lasers Imaging Retina. 2022;53:266-273.].

Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience.

PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases. [Ophthalmic Surg Lasers Imaging Retina. 2022;53:257-265.].

A Novel Surgical Technique for Ahmed Glaucoma Valve Implantation Without Plate Sutures.

PRéCIS:: A modification to the surgical technique of Ahmed glaucoma valve (AGV) implantation without plate sutures or surgical glue products has a similar safety and efficacy profile than the standard procedure, in the short and mid-term follow-up. PURPOSE: The purpose of this study was to assess the safety and efficacy of a modified AGV implantation technique without plate sutures. METHODS: A retrospective case-control study including patients seen in the Glaucoma service of an academic institution. Patients that underwent a modified AGV implantation without plate sutures were included as cases and patients that underwent standard AGV implantation, as controls. Success was defined as intraocular pressure (IOP) reduction >20%, IOP >5 and <21 without the need for additional surgical intervention, and maintenance of light perception. RESULTS: A total of 170 eyes were included. Mean (range) follow-up was 11.2±7.39 (3 to 24) months. There was no statistically significant difference in visual acuity and IOP between the groups during the postoperative period. In a univariate analysis, there was a larger decrease in IOP for the no plate suture group at the 6 months (-15.6±11.6 vs. -11.5±10.5, P=0.04) and 1 year (-16.4±10.4 vs. -11.1±10.4, P=0.02) visits. There was also a larger decrease in number of medications in the no plate suture group in the 3 months (-1.65±1.5 vs. -1.13±1.22, P=0.02), 6 months (-1.55±1.44 vs. -0.98±1.3, P=0.01) and 1 year (-1.70±1.5 vs. -1.04±1.2, P=0.04) visits. However, those differences were not confirmed by a multivariable model after adjusting for glaucoma type and number of previous glaucoma surgeries. No differences in the trajectory of the survival curves were noted between groups (P=0.36). CONCLUSION: The comparison of short and mid-term outcomes of patients undergoing AGV implantation using both techniques showed similar outcomes and success rates.

Suture Stenting of a Tube Fenestration for Early Intraocular Pressure Control After Baerveldt Glaucoma Implant Surgery.

PURPOSE: To evaluate the efficacy and safety of a tube fenestration stented with a 10-0 polyglactin suture for controlling early postoperative intraocular pressure (IOP) after Baerveldt glaucoma implant (BGI) surgery. METHODS: The medical records of 110 patients (119 eyes) who underwent BGI surgery with a tube fenestration stented with a 10-0 polyglactin suture anterior to an occlusive tube ligature were retrospectively reviewed. Main outcome measures included IOP and number of glaucoma medications at postoperative day 1, week 1, and weeks 2 to 3 as well as complications occurring before ligature release. RESULTS: Mean±SD preoperative IOP was 30.9±9.3 mm Hg using an average of 3.8±1.1 glaucoma medications. A statistically significant reduction in IOP and glaucoma medications was observed at all timepoints during the first 3 postoperative weeks compared with baseline (P<0.001). Mean IOP on postoperative day 1, week 1, and weeks 2 to 3 was 18.4±12.2 mm Hg on no medication, 15.9±9.4 mm Hg on 1.0±1.3 medications, and 16.7±8.2 mm Hg on 1.2±1.5 medications, respectively. In total, 44 eyes (37%) achieved IOP control without glaucoma medication during period of tube occlusion. CONCLUSIONS: The use of a single, monofilament 10-0 polyglactin suture to stent a fenestration proximal to the occlusive ligature of a BGI tube is effective in controlling IOP in the early postoperative period. Hypotony-related complications were infrequent and resolved in all cases with in-office interventions.

Cataract surgery cost utility revisited in 2012: a new economic paradigm.

OBJECTIVE: To assess the 2012 cost utility of cataract surgery in the United States and to compare 2012 cost-utility data with those from 2000. DESIGN: Value-Based Medicine (Flourtown, PA), patient preference-based, comparative effectiveness analysis and cost-utility analysis using 2012 real United States dollars. PARTICIPANTS: Previously published Patient Outcomes Research Team Study data and time tradeoff utilities obtained from patients with vision loss. Visual acuity measurements from patients wtih untreated cataract were used as controls. INTERVENTION: Thirteen-year, average, first-eye and second-eye cataract surgery cost-utility analysis using the societal and third-party insurer cost perspectives. MAIN OUTCOME MEASURES: Patient value gain in quality-adjusted life years (QALYs) and percent gain in quality of life as well as the cost-utility ratio using the dollars expended per QALY gained. Patient and financial value outcomes were discounted at 3% annually with net present value analysis. RESULTS: First-eye cataract surgery conferred 1.6212 QALYs over the 13-year model, a 20.8% quality-of-life gain. Bilateral cataract surgery conferred 2.8152 QALYs over 13 years, a 36.2% improvement in quality of life. The direct ophthalmic medical cost for unilateral cataract surgery in 2012 United States nominal dollars was $2653, an inflation-adjusted 34.2% less than in 2000 and 85% less than in 1985. The 2012 inflation-adjusted physician fee was 10.1% of that in 1985. The 13-year societal cost perspective, financial return on investment (ROI) for first-eye cataract surgery was $121,198, a 4567% gain. The third-party insurer cost perspective average cost-utility ratio was $2653/1.6212 = $1636/QALY for unilateral cataract surgery, whereas the societal cost perspective average cost-utility ratio was -$121,198/1.6212 = -$74,759/QALY. The net 13-year $123.4-billion financial ROI from a 1-year cohort of cataract surgery patients was accrued: Medicare, $36.4 billion; Medicaid, $3.3 billion; other insurers, $9.6 billion; patients, $48.6 billion; and increased United States national productivity, $25.4 billion. CONCLUSIONS: Cataract surgery in 2012 greatly improved quality of life and was highly cost effective. It was 34.4% less expensive than in 2000 and 85% less expensive than in 1985. Initial cataract surgery yielded an extraordinary 4567% financial ROI to society over the 13-year model.

Significance of initial aortic aneurysm pressure sensor readings varies with aortic endograft design.

BACKGROUND: The differences in implantable pressure sensor aneurysm sac readings were compared following endovascular aneurysm repair (EVAR) among three different stent grafts. METHODS: From January 2006 to March 2009, 51 aortic stent grafts were implanted along with the Endosure sensor. Grafts used were Zenith, Talent, and Excluder. In the present retrospective study, pulse ratios were measured intraoperatively before and after aneurysm sac exclusion and in follow-up (within 30 days). Analysis of variance was used to determine significance. RESULTS: The average aneurysm size that was repaired was 5.75 cm (range: 4-8.5 cm); 41 patients (80.4%) being male with an average age of 76.3 years (range: 58-90 years). Thirty-four grafts were Zenith, 9 were Talent, and 8 were Excluder. The average pre-aneurysm exclusion pulse ratios for the Zenith, Talent, and Excluder were 1.00, 1.08, and 0.95 (p = 0.18), respectively. The average post-aneurysm exclusion pulse ratios were 0.34, 0.67, and 0.35, respectively (p = 0.003). Pulse ratios at the time of follow-up (within 30 days) were 0.17, 0.22, and 0.11, respectively (p = 0.44). Nine of 51 (17.6%) patients had a reduction of pulse ratio of less than 30% after endograft implantation. Five of those 9 patients (55.5%) had the Talent endograft, although there was no angiographic evidence of endoleak. CONCLUSIONS: The Talent graft has significantly higher pulse ratios following endograft implantation despite having no angiographic evidence of endoleak when compared to the Zenith and Excluder grafts. However, the pulse ratios decreased to levels similar to Zenith and Excluder within 30 days of endograft implantation. This suggests that the Talent endograft may have increased porosity initially. If pulse ratios do not appropriately decrease immediately after device implantation, further angiographic imaging may not be necessary if no obvious endoleak is seen.