Sight-threatening Adverse Events Research Articles

Myopia control with orthokeratology lenses. A 3-year follow-up study including a cross-over design: Clinical study Of Near-sightedness; TReatment with Orthokeratology Lenses 2 (CONTROL2 study).

The purpose of this study is to investigate 3-year efficacy of orthokeratology lenses (OKL) in controlling axial length progression in myopic Scandinavian children. Through a cross-over design of the control group to compare the treatment efficacy in younger versus older children, with the latter having higher cycloplegic spherical refractive error (cSEQ) at treatment initiation. Further, the study aimed to evaluate the safety of the treatment. This was a continuation of the randomized controlled study Clinical study Of Near-sightedness; TReatment with Orthokeratology Lenses (CONTROL study) in which the follow-up period of the original intervention group, that received OKL, was extended from 18 months to 36 months. Meanwhile, the original control group was crossed-over to OKL after the 18-month follow-up visit and treated for 18 months. Biometry was measured using Lenstar LS900, and contact lens complications were graded according to Efron Grading Scale for Contact Lens Complications (Efron score). Mixed models were used for statistical analysis. Nineteen subjects in the OKL group and 28 in the control group completed the CONTROL study. Hereof, 17 and 24 subjects from the OKL group and control group, respectively, agreed to participate in the CONTROL2 study. In the OKL continue group, the treatment efficacy did not decline during the 3-year study period (p-values for follow-up visits were all ≥0.82). There was no statistically significant difference between treatment efficacy when OKL treatment was initiated in younger versus older children (p-value ≥0.14 for all follow-up visits). Low-grade corneal staining was seen in several subjects at some point during the study, but here were no treatment-requiring or sight-threatening adverse events during the study period. The efficacy of myopia control by OKL was stable during 3 years of treatment. Similar treatment efficacies were found regardless of the age at treatment initiation. No severe adverse events occurred during the study period.

A 2-Year, Single-Center Study to Assess the Safety and Effectiveness of the MicroShunt in Primary Open-Angle Glaucoma

Aim: The aim of the study was to assess the effectiveness and safety of the MicroShunt (formerly known as the MIDI-Arrow or InnFocus MicroShunt®), an 8.5-mm-long, 70-μm lumen-controlled ab externo glaucoma filtration surgery device made from poly(styrene-block-isobutylene-block-styrene) (SIBS), in patients with primary open-angle glaucoma (POAG). Methods: A 2-year, single-center, single-surgeon, nonrandomized, adaptive feasibility clinical study (NCT01563237) was conducted in France from June 2011 to November 2016. Eligible patients were aged 18–85 years and had POAG inadequately controlled on maximum tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤40 mm Hg. The MicroShunt was implanted ab externo with adjunctive use of mitomycin C (0.2–0.4 mg/mL applied for 2–3 min), alone or in combination with cataract surgery. The primary effectiveness endpoints were the reduction in IOP relative to the preoperative value assessed at each postoperative visit and the measurement of success at years 1 and 2. The primary safety endpoint was the incidence of all procedure- and/or device-related adverse events (AEs) during the study. The secondary effectiveness endpoint was the mean number of glaucoma medications per patient, and the secondary safety endpoint was the incidence of glaucoma reoperation. Results: Sixty-one eyes from 61 patients underwent MicroShunt implantation. Mean IOP ± standard deviation (SD) was significantly reduced from 25.7 ± 6.1 mm Hg at baseline (N = 61) to 15.8 ± 4.7 mm Hg at year 1 (n = 58) and 16.5 ± 6.0 mm Hg at year 2 (n = 52) (both p < 0.001). Overall success rates for patients achieving IOP ≥6 mm Hg and <21 mm Hg at year 1 and year 2 were 80.3% and 75.4%, respectively. Mean ± SD number of glaucoma medications per patient decreased significantly from 2.9 ± 1.1 at baseline to 0.6 ± 1.0 at year 1 (n = 58) and 1.0 ± 1.3 at year 2 (n = 52) (both p < 0.001). The most common procedure- and/or device-related AEs were investigator-reported increased IOP and hyphema. Four patients required reoperation. Conclusions: In this study, sustained reductions in mean IOP and number of glaucoma medications from baseline were observed up to 2 years post-surgery. No long-term, sight-threatening AEs were observed.

Topical Review: Contact Lens Eye Health and Safety Considerations in Government Policy Development.

SIGNIFICANCEAs new federal or state policies are introduced in the United States to shape the evolving contact lens market, it has never been more important to amplify the importance of patient health and safety during contact lens wear and promote the value of the eye care professional–patient relationship.Within the United States, contact lenses are regulated by the Food and Drug Administration as class II or III medical devices that require additional regulatory and professional oversight to keep consumers safe. The contact lens market and broader eye health landscape are rapidly changing. Recently, the U.S. Federal Trade Commission finalized its 10-year review of the Contact Lens Rule, implementing new policies that will shape the contact lens market in the United States for years to come. The purpose of this clinical perspective was to compile and review key data regarding contact lens–related adverse events, including their economic impact on the health care system, to inform government policy development. Although contact lenses provide many benefits to the wearer, a variety of complications can occur ranging from asymptomatic events or mild discomfort to severe sight-threatening adverse events such as microbial keratitis. Patients who do not routinely visit their eye care professional or do not receive the lenses prescribed to them are at a greater risk of contact lens–related adverse events. Nearly 1 million people in the United States experience ocular infections or inflammation annually, resulting in significant health care costs. The economic burden of contact lens–related microbial keratitis in the United States has been estimated to be approximately $175 million annually. The importance of eye care professional oversight of contact lens wear cannot be emphasized enough to key stakeholders, including lawmakers, government regulators, contact lens manufacturers and distributors, and the broader eye health community.

Glaucoma medical treatment as a predictor of XEN45 subconjunctival gel implant hypotensive efficacy.

The aim of this study was to determine the preoperative characteristics influencing hypotensive efficacy of the XEN45 gel stent in patients with open-angle glaucoma at one-year follow-up. This was a retrospective multicentre study. All patients who underwent XEN45 gel stent implantation between January 2017 and January 2021 were included. The main study outcome was the assessment of one-year postoperative intraocular pressure (IOP) and glaucoma medication differences according to the number and type of preoperative topical treatments or glaucoma surgery, glaucoma stage and time since diagnosis. Follow-up period was 1-year post-surgery in all cases. IOP reduction and surgery success (not requiring reoperation or pressure failures [IOP > 18mmHg and < 20% reduction in IOP]), safety and cost savings in topical glaucoma therapy after surgery were secondarily assessed. Linear regression analysis to determine the preoperative parameters influence on 1-year postoperative results was performed. XEN45 gel stent was implanted in 85 patients. One-year postoperative mean IOP dropped from 20.6 ± 4.1 to 13.7 ± 2.8mmHg (p < 0.0001). Likewise, mean number of topical treatments decreased from 2.05 ± 0.9 to 0.36 ± 0.65 (p < 0.001). Both were mainly influenced by the number of preoperative glaucoma treatments, such that for each one-glaucoma medication increase, postoperative intraocular pressure increased by 1.18mmHg (95% CI 0.56-1.79, p < 0.0001) and number of glaucoma medications increased by 0.3 (95% CI 0.16-0.43, p < 0.001). Overall success rates (with and without supplemental glaucoma medication use) were 97.6% (95% CI 94.5-100%), 87.1% (95% CI 80.2-87.1%) and 61.2% (95% CI 51.6-72.5%) at 3, 6months and 1year after surgery. No sight-threatening adverse events were reported. Mean annual cost savings on medical treatment since surgery reached EUR 251.19 ± 169. 93 euros. One year after surgery, XEN45 gel implant significantly reduced IOP and number of topical medications with an adequate safety profile being both mainly influenced by the number of preoperative glaucoma treatments.

Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study

To assess the safety and effectiveness of the PRESERFLO® MicroShunt (formerly InnFocus MicroShunt) in patients with primary open-angle glaucoma (POAG). The MicroShunt, a controlled ab externo glaucoma filtration surgery device, was investigated in a 2-year, multicenter, single-arm study. Eligible patients were aged 18-85 years with POAG inadequately controlled on maximal tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg or when glaucoma progression warranted surgery. The MicroShunt was implanted as a stand-alone procedure with adjunctive use of topical mitomycin C (MMC; 0.2-0.4 mg/ml) for 2-3 minutes. The primary effectiveness outcome was IOP reduction and success (not requiring reoperation or pressure failures [IOP > 21 mmHg and < 20% reduction in IOP]) at year 1. Additional end points at year 2 included IOP reduction, success, glaucoma medications, adverse events (AEs), and reoperations. Results are reported in the overall population and subgroups of patients receiving 0.2 or 0.4 mg/ml MMC. In 81 patients, mean (± standard deviation [SD]) IOP decreased from 21.7 ± 3.4 mmHg at baseline to 14.5 ± 4.6 mmHg at year 1 and 14.1 ± 3.2 mmHg at year 2 (P < 0.0001). Overall success (with and without supplemental glaucoma medication use) at year 1 was 74.1%. Mean (± SD) number of medications decreased from2.1 ± 1.3 at baseline to 0.5 ± 0.9 at year 2 (P < 0.0001), and 73.8% of patients were medication free. Most common nonserious AEs were increased IOP requiring medication or selective laser trabeculoplasty (25.9%) andmild-to-moderate keratitis (11.1%). There were 6 (7.4%) reoperations and 5 (6.2%) needlings by year 2. Inananalysis (post hoc) according to MMC concentration, overall success was 78.1% (0.2 mg/ml) and 74.4% (0.4 mg/ml; P=0.710). In the 0.2 and 0.4 mg/ml MMC groups, 51.9% and 90.3% of patients were medication free, respectively (P= 0.001). There was a trend toward lower IOP and higher medication reduction in the 0.4mg/ml MMC subgroup. In this study, mean IOP and glaucoma medication reductions were significant and sustained over2 years postsurgery. No long-term, sight-threatening AEs were reported. Further studies may confirm potential risk/benefits of higher MMC concentration.

Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study.

Precis:The MicroShunt was implanted in 23 patients with primary open-angle glaucoma (POAG) in a feasibility study. Reductions in intraocular pressure (IOP) and medications were sustained for up to 5 years with no long-term sight-threatening adverse events (AEs).Purpose:The purpose of this study was to assess the long-term effectiveness and safety of the PRESERFLO MicroShunt (8.5 mm long, 70 µm lumen surgical device, formerly known as the InnFocus MicroShunt) in POAG.Patients and Methods:In a feasibility study (NCT00772330), patients with POAG inadequately controlled on maximum tolerated therapy with IOP ≥18 to ≤40 mm Hg underwent MicroShunt implantation with adjunctive mitomycin C (0.4 mg/mL), alone or in combination with cataract surgery. Years 1 to 3 findings have previously been reported. Endpoints of this extension study included IOP reduction and success at years 4 and 5 (primary), incidence of AEs, medication use, and reoperations.Results:Mean IOP was reduced from 23.8±5.3 mm Hg at baseline to 12.8±5.6 mm Hg (year 4; n=21) and 12.4±6.5 mm Hg (year 5; n=21). Overall success (with/without medication use) was 87.0% (year 4) and 82.6% (year 5). The mean number of medications reduced from 2.4±1.0 at baseline to 0.8±1.3 (year 5). Common (≥5% of patients) AEs included corneal edema (n=4), transient hypotony (n=4), bleb-related complications (n=3), and device touching the iris (n=3). There were 4 reports of serious AEs and 2 reoperations.Conclusions:In this extension study, sustained reductions in mean IOP and medications were observed up to 5 years post-MicroShunt implantation. There were no reports of long-term sight-threatening AEs and a low rate of postoperative interventions.

Post-surgical management of cataract: Light and dark in the 2020s

Cataract surgery is the most frequently performed elective surgery worldwide. Although considered a safe procedure, potentially sight-threatening adverse events are possible. Among these, post-surgical inflammation and infections are the most relevant. Anti-inflammatory drugs, such as corticosteroids, and topical antibiotics are the pillars for the treatment of inflammation and for the prevention of infections. However, uncertainties remain regarding the duration of both topical antibiotic prophylaxis and corticosteroid treatment. LEADER7, a recent international clinical study conducted with the new fixed combination of levofloxacin and dexamethasone eye drops in patients undergoing uncomplicated cataract surgery, found that 1-week topical antibiotic prophylaxis is just as effective as the 2-week course commonly used in clinical practice. The study also showed that treatment for 1 week with dexamethasone results in complete resolution of inflammatory signs and symptoms in over 85% of patients, for whom further prolongation of corticosteroid treatment is, therefore, not necessary. This new treatment strategy can represent a significant step forward to reduce the unjustified use of prophylactic antibiotics after cataract surgery, limiting the emergence of bacterial resistance, as well as representing an opportunity to optimize the use and safety of the corticosteroid treatment.

Outcomes and Adverse Events of Sub-Tenon's Anesthesia with the Use of a Flexible Cannula in 35,850 Refractive Lens Exchange/Cataract Procedures.

PurposeTo describe our technique of sub-Tenon’s anesthesia and report adverse events and patient comfort.SettingOptical Express, United Kingdom.DesignRetrospective case series.MethodsThe outcomes of 35,850 intraocular procedures (phacoemulsification and implantation of an intraocular lens) were retrospectively reviewed and the incidence of adverse events related to sub-Tenon’s anesthesia was calculated. On the first postoperative day, patients were asked to complete a questionnaire enquiring about their comfort during and after the procedure. The anesthetic solution consisted of a combination of Lidocaine and Hyaluronidase, which was administered into sub-Tenon’s space with a single-use sterile polyurethane 22G x 1” (0.9 x 25 mm) cannula. Mild conscious sedation (midazolam) was used during anesthetic and surgical procedure.ResultsNo significant adverse events that would affect the posterior segment of the eye or result in vision loss were recorded. Subconjunctival haemorrhage related to sub-Tenon’s anesthesia was noted in 4.3% of eyes. Five minutes after the administration of sub-Tenon’s block, 80.6% of eyes had no chemosis, 14.8% had chemosis that affected only 1 quadrant of the eye and 4.5% of eyes had chemosis affecting 2 or more quadrants of the eye. Other adverse events included 14 cases of cyst/granuloma formation in the area of sub-Tenon’s incision and 7 eyes required suturing of the conjunctival cut. Of all patients, 93.2% experienced no or only mild discomfort during or after surgical procedure.ConclusionSub-Tenon’s anesthesia with the use of a flexible cannula is a safe option for ophthalmic anesthesia. No sight-threatening adverse events occurred.

Six-Month Outcomes of Goniotomy Performed with the Kahook Dual Blade as a Stand-Alone Glaucoma Procedure.

IntroductionTo characterize the reduction in intraocular pressure (IOP) and IOP-lowering medication use following goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade as a stand-alone procedure in adult eyes with glaucoma uncontrolled on a regimen of 1–3 topical IOP-lowering medications.MethodsIn this retrospective analysis, data from consecutive patients undergoing goniotomy with the Kahook Dual Blade by 11 surgeons were analyzed. Preoperative, intraoperative, and postoperative follow-up data through 6 months of follow-up were collected. The primary efficacy endpoint was IOP reduction from preoperative baseline; reduction in IOP-lowering medication use was a secondary endpoint.ResultsData were collected from 53 eyes of 42 subjects. Mean (± SE) preoperative IOP was 23.5 ± 1.1 mmHg, and from day 1 through 6 months of postoperative follow-up mean IOP reductions of 7.0–10.3 mmHg (29.8–43.8%; p < 0.001 at each time point) were observed. Mean preoperative medication use was 2.5 ± 0.2 medications per eye and was reduced by month 6 to 1.5 ± 0.2 (a 40.0% reduction; p < 0.05). Eyes with higher baseline IOP experienced mean IOP reductions of 13.7 mmHg (− 46.4%) at month 6, while eyes with lower baseline IOP experienced mean IOP reductions of 3.8 mmHg (− 21.0%) at month 6. Mean medications were reduced by 1.3 medications in high-IOP eyes and by 0.9 in low-IOP eyes at month 6. No significant sight-threatening adverse events were observed.ConclusionsGoniotomy via trabecular meshwork excision performed using the Kahook Dual Blade effectively and safely lowered IOP when performed as a stand-alone procedure in eyes with glaucoma. The significant drop in IOP met or exceeded the recommended targets for these glaucoma patients.FundingNew World Medical, Inc.

Keep an eye on the SSRI: help avoid possible sight-threatening adverse events.

A recent report in a peer-reviewed UK journal outlines five cases of optic neuropathy thought to be related to long-term treatment with selective serotonin reuptake inhibitors (SSRIs).1 These five were identified over a 2-year period within an island population of 140 000. Each case was assessed using the Naranjo algorithm to indicate likelihood of adverse drug reaction (ADR).2 The Naranjo scores indicated possible ADR in four cases and probable ADR in one case. All five cases presented with visual loss from suspected ischaemic optic neuropathy (ION) and were all extensively investigated for any other possible underlying cause. A ‘non-arteritic’ ischaemic origin was suspected in all cases. Toxicity was felt to be unlikely since three cases were of sudden onset and two cases were unilateral. Two cases …

Serious adverse events after cataract surgery

Over the past several decades, there have been many advances in the equipment, instrumentation and techniques of performing cataract surgery. This review will address the impact of these advances on the safety profile of cataract surgery. Recent studies have demonstrated a decline in the risk of serious postoperative adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) following cataract surgery. Factors that increase the risk of serious complications from cataract surgery include patient-related factors (male sex, concomitant diabetic retinopathy, same day cataract surgery combined with another intraocular surgery, tamsulosin use) and surgeon-related factors (low surgical volume, limited experience, operating on patients who are most prone to adverse events). Cataract surgery continues to be a very well tolerated surgical procedure with few patients experiencing serious sight-threatening adverse events. Studies in the literature have helped surgeons identify patients who are at high risk for surgical complications and develop strategies to limit surgical complications when operating on these patients. As multifocal intraocular lenses, femtosecond laser technology, and other surgical innovations continue to gain popularity, it will be interesting in the coming years to determine whether there will be a continued reduction in complications of cataract surgery.

Severe Adverse Events after Cataract Surgery Among Medicare Beneficiaries

To determine rates and risk factors associated with severe postoperative complications after cataract surgery and whether they have been changing over the past decade. Retrospective longitudinal cohort study. A total of 221 594 Medicare beneficiaries who underwent cataract surgery during 1994-2006. Beneficiaries were stratified into 3 cohorts: those who underwent initial cataract surgery during 1994-1995, 1999-2000, or 2005-2006. One-year rates of postoperative severe adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) were determined for each cohort. Cox regression analyses determined the hazard of developing severe adverse events for each cohort with adjustment for demographic factors, ocular and medical conditions, and surgeon case-mix. Time period rates of development of severe postoperative adverse events. Among the 221 594 individuals who underwent cataract surgery, 0.5% (1086) had at least 1 severe postoperative complication. After adjustment for confounders, individuals who underwent cataract surgery during 1994-1995 had a 21% increased hazard of being diagnosed with a severe postoperative complication (hazard ratio [HR] 1.21; 95% confidence interval [CI], 1.05-1.41) relative to individuals who underwent cataract surgery during 2005-2006. Those who underwent cataract surgery during 1999-2000 had a 20% increased hazard of experiencing a severe complication (HR 1.20; 95% CI, 1.04-1.39) relative to the 2005-2006 cohort. Risk factors associated with severe adverse events include a prior diagnosis of proliferative diabetic retinopathy (HR 1.62; 95% CI, 1.07-2.45) and cataract surgery combined with another intraocular surgical procedure on the same day (HR 2.51; 95% CI, 2.07-3.04). Individuals receiving surgery by surgeons with the case-mix least prone to developing a severe adverse event (HR 0.52; 95% CI, 0.44-0.62) had a 48% reduced hazard of a severe adverse event relative to recipients of cataract surgery performed by surgeons with the case-mix most prone to developing such outcomes. Rates of sight-threatening adverse events after cataract surgery declined during 1994-2006. Future efforts should be directed to identifying ways to reduce severe adverse events in high-risk groups.

Value of internal limiting membrane peeling in surgery for idiopathic macular hole and the correlation between function and retinal morphology

Idiopathic macular hole is characterized by a full thickness anatomic defect in the foveal retina leading to loss of central vision, metamorphopsia and a central scotoma. Classic macular hole surgery consists of vitrectomy, posterior vitreous cortex separation and intraocular gas tamponade, but during the past decade focus has especially been on internal limiting membrane (ILM) peeling as adjuvant therapy for increasing closure rates. With increasing use of ILM peeling and indocyanine green (ICG) staining, which is used for specific visualization of the ILM, concerns about the safety of the procedure have arisen. At present, it is not known whether ICG-assisted ILM peeling potentially reduces the functional outcome after macular hole surgery. The purpose of the present PhD thesis was to examine whether ICG-assisted ILM peeling offers surgical and functional benefit in macular hole surgery. We conducted a randomized clinical trial including 78 pseudophakic patients with idiopathic macular hole stages 2 and 3. Patients were randomly assigned to macular hole surgery consisting of (i) vitrectomy alone without instrumental retinal surface contact (non-peeling), (ii) vitrectomy plus 0.05% isotonic ICG-assisted ILM peeling or (iii) vitrectomy plus 0.15% trypan blue (TB)-assisted ILM peeling. Morphologic and functional outcomes were assessed 3, 6 and 12 months after surgery. The results show that surgery with ILM peeling, for both stages 2 and 3 macular holes, is associated with a significantly higher closure rate than surgery without ILM peeling (95% versus 45%). The overall functional results confirm that surgery for macular hole generally leads to favourable visual results, with two-thirds of eyes regaining reading vision (>or=20/40). Macular hole surgery can be considered a safe procedure with a low incidence of sight-threatening adverse events; the retinal detachment rate was 2.2%. Visual outcomes in eyes with primary hole closure were not significantly different between the intervention groups; however, for the stage 2 subgroup with primary macular hole closure, there was a trend towards a better mean visual acuity in the non-peeling group (78.2 letters) compared to the ICG-peeling group (70.9 letters), p = 0.06. Performing repeated macular hole surgery was associated with a significant reduction in functional outcome indicating that primary focus should be on closing the macular hole in one procedure. Morphological studies of closed macular holes with contrast-enhanced optical coherence tomography (OCT) found thinning and discontinuity of the central photoreceptor layer matrix that were highly specific for predicting the likelihood of an eye having regained reading vision 12 months after macular hole surgery. Additionally, healing after macular hole surgery appeared to begin with the contraction of the inner aspect of the retina, forming a roof over a subfoveal fluid-filled cavity, and to end with a gradual restoration of the anatomy in the outer layers of the retina at the junction of the photoreceptor inner and outer segments. We found the more intact this structure was on contrast-enhanced OCT 3 months after macular hole surgery, the better the visual acuity after 12 months, whereas late rather than early resolution of subfoveal fluid had no impact on final visual outcome. The use ILM peeling and intraoperative dyes did not have any functionally important effects on postoperative macular structure. Based on the above findings, we conclude that ILM peeling should be performed in all cases of full thickness macular hole surgery. The use of 0.05% intraoperative isotonic ICG with short exposure time appears to be a safe alternative in stage 3 macular hole surgery, whereas a slight reduction in functional potential not can be excluded when performing 0.05% isotonic ICG-assisted ILM peeling in stage 2 macular hole surgery.