Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery.

Introduction: The aim of the study was to define a core outcome set (COS) to be measured following cataract surgery for the postoperative evaluation of monofocal intraocular lenses (IOLs). Compared to current COSs, the present work provides updates considering the advances in the technology due to the development of new generation monofocal IOLs, which are characterized by a safety profile comparable to standard monofocal IOLs but with an extended range of intermediate vision. Methods: Healthcare professionals (ophthalmologist surgeons) and patients were involved in the selection of outcomes to be included in the COS, starting from a list of indicators retrieved from a systematic literature search. The search considered observational studies with both a retrospective or prospective design, case studies and classic randomized controlled trials (RCTs). A mixed methodology integrating a Delphi-driven and an expert panel approach was adopted to reach an agreement among clinicians, while patients were involved in the completion of a questionnaire. Results: The final COS included 15 outcomes. Eleven outcomes, all clinical, were considered for inclusion after a joint discussion among ophthalmologists; seven outcomes were linked to visual acuity, while the remaining to contrast sensitivity, refractive errors, aberrations and adverse events. Measurement metrics, method of aggregation and measurement time point of these outcomes were specified. The most important aspects for the patients were (1) quality of life after cataract surgery, (2) the capacity to perform activities requiring good near vision (e.g., reading), (3) spectacle independence, and (4) safety of movements without fear of getting hurt or falling (intermediate vision). Discussion: In a context with limited healthcare resources, it is important to optimize their use considering also the preferences of end-users, namely patients. The proposed COS, developed involving both ophthalmologists and patients, provides an instrument for the postoperative evaluation of different technologies in the context of monofocal IOLs, which can be used not only in clinical trials but also in clinical practice to increase the body of real-world evidence.

Ultrasound or MRI in the Evaluation of Anterior Talofibular Ligament (ATFL) Injuries: Systematic Review and Meta-Analysis.

OBJECTIVES: Ankle sprains represent the second most common cause of emergency department access for musculoskeletal injury and lateral ankle ligament complex tears account for 850,000 cases annually in the United States with a relapse rate of 70%. Clinical examination is limited due to its subjectivity and the difficulty of identifying a specific involvement of the ligament; therefore, US and MRI are frequently requested. Therefore, the goal of this study is to analyze the available literature on the use of ultrasound (US) and magnetic resonance imaging (MRI) to diagnose injuries to the anterior talofibular ligament (ATFL) with a meta-analytic approach. METHODS: According to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, all studies regarding the diagnostic accuracy of ultrasound and magnetic resonance imaging ATFL injuries were searched and assessed. The data were obtained from two independent reviewers with 12 and 3 years of experience in meta-analysis. A QUADAS-2 (Quality Assessment of Studies of Diagnostic Accuracy Studies) checklist was carried out to assess the risk of biases. From the selected studies, the sensitivity, specificity, and accuracy data were extracted. RESULTS: Nine studies were included. The results of the meta-analysis demonstrate a greater sensitivity for ultrasound [96.88 (95% CI: 94-99) (fixed effects); 97 (95% CI: 94-99) (random effects)] compared to MRI [88.50 (95% CI: 85-91) (fixed effects); 86.98 (95% CI: 77-94) (random effects)], p < 0.05. The result of this meta-analysis shows that the less expensive diagnostic technique is also the most sensitive for the diagnosis of ATFL tears. Ultrasound articles resulted to have non-heterogeneity [(p = 0.2816; I° = 21.4607%)]. CONCLUSION: This meta-analysis demonstrates that US appears to be a highly sensitive diagnostic technique for diagnosing tears of the ATFL. Compared to MRI, the sensitivity of US result was higher.

Effectiveness and Safety of XEN45 in Eyes With High Myopia and Open Angle Glaucoma.

PRCIS: XEN45 implant was an effective and safe procedure in primary open angle glaucoma (OAG) eyes with high myopia. Although the hypotony incidence rate was relatively high, it resolved with medical therapy and was of short duration. PURPOSE: The purpose of this study is to evaluate the effectiveness and safety of the XEN45 stent in eyes with OAG and high myopia. DESIGN: Retrospective and multicenter study. METHODS: Consecutive OAG patients who underwent a XEN45, either alone or in combination with cataract surgery, and had a refractive error higher than -6 D and an axial length ≥26 mm. The primary endpoint was the mean intraocular pressure (IOP) lowering at the last follow-up visit. RESULTS: Thirty-one eyes were included (96.8% with a primary OAG diagnosis). The mean refraction was -13.2±5.6 (range: -6.75 to-23.0) D. In the overall study sample, preoperative mean IOP (95% CI) was significantly lowered from 23.5 (20.5-26.4) mm Hg to 13.0 (12.2-13.8) mm Hg at the last follow-up visit, P <0.0001. At the last follow-up visit, 16 (57.1%) eyes achieved an IOP ≤14 mm Hg, 11 (68.9%) of them without treatment. The number of ocular hypotensive medications was significantly reduced from 3.0±1.1 drugs at preoperatively to 0.6±1.0 drugs at the last follow-up visit, P <0.0001. Median (95% CI) follow-up was 24.0 (12.0-24.0) months. Linear regression analysis showed a significant correlation between the preoperative refraction and the IOP lowering ( r =0.43, P =0.0155). Needling procedure was performed in 11 eyes (39.3%) and hypotony (defined as an IOP <6 mm Hg) was observed in 8 eyes (28.6%) during the first postoperative day and remained for a week. CONCLUSION: Although the Xen implant effectively lowered IOP in highly myopic eyes with glaucoma, the incidence of hypotony was high, and in most cases, resolved within the first month with medical management and monitoring.

A case of malignant glaucoma following insertion of Preserflo™ MicroShunt.

PURPOSE: To describe a case of malignant glaucoma following insertion of a Preserflo™ MicroShunt in a patient with primary open angle glaucoma (POAG). DESIGN: Case report. CASE: A 46-year-old Caucasian man with medically uncontrolled POAG developed malignant glaucoma 1 day after an uncomplicated insertion of a mitomycin C (MMC) augmented Preserflo MicroShunt (PMS). RESULTS: Initial medical treatment with aqueous suppressants and atropine 1% resulted in temporary resolution of the episode, although partial occlusion of the PMS with iris required a Nd:YAG laser iridotomy to open the inlet of the device. However, the malignant glaucoma recurred 6 days later. Temporary resolution was subsequently achieved with an Nd:YAG laser peripheral irido-zonulo-hyaloidotomy in combination with topical atropine, though a subsequent PMS revision was required due to bleb encapsulation. Unfortunately, the revision procedure was followed 2 days later, by a further recurrence of malignant glaucoma which was eventually resolved by left pars plana vitrectomy (PPV) in combination with clear lens extraction (CLE) and surgical irido-zonulo-hyaloidectomy. Subsequently, the eye remained stable, with a deep anterior chamber (AC), a partially functioning bleb, and an intraocular pressure (IOP) of 14 mmHg on one topical IOP-lowering agent, 8 months after the last procedure. CONCLUSIONS: The management of malignant glaucoma after PMS insertion and its subsequent clinical course is described. Apart from the propensity for a small tube such as the PMS to obstruct with iris when the AC is shallow, management is similar to other scenarios in which malignant glaucoma may develop.

One Year Outcomes and Stability of a Novel Scleral Anchored Intraocular Lens.

PURPOSE: To assess one year results and stability of the implantation of a scleral anchored intraocular lens (IOL). DESIGN: Interventional prospective case series. METHODS: Sixty eyes of 60 patients affected by either aphakia or IOL dislocation were included in this study. Patients underwent vitrectomy, scleral fixation of the IOL, and, if present, dislocated IOL removal. Patients were evaluated preoperatively and at 1, 3, 6, and 12 months after surgery by best-corrected distance visual acuity (BCVA) assessment, intraocular pressure (IOP) measurement, corneal specular microscopy, and optical coherence tomography (OCT) of both the macula and anterior segment. RESULTS: At twelve months, mean BCVA significantly improved (p < 0.0001), and none of the patients experienced a decrease of visual acuity. A 10% decrease of endothelial cell count occurred after surgery. Cystoid macular edema occurred in three patients (5%). A transient increase of intraocular pressure was noted in 7 cases (12%). At one month, horizontal and vertical IOL tilt was 1.04 ± 0.87 and 0.74 ± 0.71 degrees, respectively, and did not significantly change in the follow-up (p > 0.05). None of the patients had decentration or dislocation of scleral-fixated IOL during the follow-up. CONCLUSION: Implantations of scleral plug fixated IOL provide good visual results, low complication rate, and excellent stability of the lens until one-year follow-up.