A Prospective, Randomized, Controlled Clinical Investigation Comparing the Efficacy and Safety of Sodium Hyaluronate-Based Ophthalmical Viscosurgical Devices FIDIAL PLUS and IAL®-F in Cataract Surgery.

Purpose: To protect the corneal endothelium, various ophthalmical viscoelastic devices (OVDs) are used during cataract surgery. In this study, we compared two sodium hyaluronate-based OVD, the bacteria-derived FIDIAL PLUS OVD (test) with the animal-derived IAL®-F OVD (reference) during the surgical procedure. Methods: Fifty patients with bilateral cataract participated in the study: 50 eyes randomly received FIDIAL PLUS and 50 eyes received IAL®-F (ratio 1:1). Noninferior efficacy of FIDIAL PLUS compared with reference OVD (first objective) was evaluated using a paired t-test comparing the mean percent loss of corneal endothelial cells (CECs) with FIDIAL PLUS against the mean percent loss with IAL®-F. Corneal endothelial protection during cataract surgery with FIDIAL PLUS without significant (≥30 mmHg) postoperative intraocular pressure (IOP) increase (main secondary objective) was assessed using a repeated measures logistic model comparing the incidence of significant postoperative IOP elevation between the two groups. Safety, tolerability, and efficacy were also evaluated by assessing secondary endpoints before and after surgery. Results: FIDIAL PLUS showed a statistically noninferior efficacy compared with IAL®-F; there was no significant increase in IOP in either group or different trends of the secondary endpoints were observed between the OVD groups. The safety profile was similar in both OVD groups and no adverse device effects were reported. Conclusions: This study demonstrates the equivalent efficacy, tolerability, and safety of the bacteria-derived FIDIAL PLUS compared with the animal-derived IAL®-F, confirming the clinical value of this product.

A case of bilateral pseudophakic malignant glaucoma treated with a new variant of irido-zonulo-hyaloid-vitrectomy.

Purpose: To describe a case of bilateral pseudophakic malignant glaucoma treated with a new variant of irido-zonulo-hyaloid-vitrectomy. Observations: A patient who developed refractory bilateral pseudophakic malignant glaucoma underwent an irido-zonulo-hyaloid-vitrectomy via the anterior chamber in both eyes, one 2-months apart from the other. The procedure involved the use of an 18 Gauge needle to perform a straight vertical irido-zonulo-hyaloidotomy and a 25 Gauge vitreous cutter to complete the vitrectomy. The intraocular pressure was recorded on day 1, day 7, day 14, then monthly until 6 months postoperatively, whereas an ultrasound biomicroscopy of the anterior chamber was performed on day 1 and 6 months after the operation. The malignant glaucoma resolved in both eyes with no intra- nor post-operative complications. At 6 months from the surgeries none of the eyes developed recurrences. Conclusions: The new variant of irido-zonulo-hyaloid-vitrectomy we propose for the management of refractory pseudophakic malignant glaucoma resulted to be a safe and effective technique.

Bilateral angle-closure during hospitalization for coronavirus disease-19 (COVID-19): A case report.

PURPOSE: This report describes a case of bilateral primary angle closure (PAC) progressing to unilateral end-stage primary angle closure glaucoma (PACG) associated with treatment for coronavirus disease-19 (COVID-19) infection. METHODS: A 64-year-old man came to our attention because of blurred vision after a 2-month hospital stay for treatment of COVID-19 infection. Examination findings revealed PACG, with severe visual impairment in the right eye and PAC in the left eye due to plateau iris syndrome. The patient's severe clinical condition and prolonged systemic therapy masked the symptoms and delayed the diagnosis. Medical chart review disclosed the multifactorial causes of the visual impairment. Ultrasound biomicroscopy (UBM) aided in diagnosis and subsequent therapy. RESULTS: The cause behind the primary angle closure and the iridotrabecular contact was eliminated by bilateral cataract extraction, goniosynechialysis, and myotic therapy. CONCLUSIONS: COVID-19 treatment may pose an increased risk for PAC. Accurate recording of patient and family ophthalmic history is essential to prevent its onset. Recognition of early signs of PAC is key to averting its progression to PACG.

Double versus single suture stenting to manage hypertensive spikes after glaucoma drainage device implantation.

PURPOSE: To evaluate the safety and efficacy of double compared to single intraluminal suture stenting in reducing early postoperative hypertensive spikes (HS) and hypotony after Baerveldt glaucoma implant surgery. METHODS: For this retrospective study, we reviewed the medical charts of 60 patients (60 eyes) who underwent Baerveldt drainage device surgery between 2017 and 2019. Two groups were formed according to whether a single suture stent was placed within the tube (5-0 polypropylene, 30 eyes, group 1) or a double suture (5-0 and 6-0 polypropylene, 30 eyes, group 2). Intraocular pressure (IOP) was measured at baseline, at 6 h, and on postoperative days 1, 2, 5, 7, 14, 21, 30, 60, 90, 180. The occurrence of HS (IOP ⩾ 30 mmHg), anterior chamber reformation, decompressive paracentesis, anti-glaucoma medication, and adverse events were recorded. RESULTS: There was a greater decrease in IOP from baseline at days 1, 2, and 21 (p < 0.05) and number of HS at 6 h (p = 0.006) and postoperative day 1 (p < 0.001) in group 2. The mean number of decompressive paracentesis, anterior chamber reformation procedures, and topical anti-glaucoma medications was the same in both groups; the need for oral acetazolamide was significantly lower in group 2 at days 1, 21, and 30 (p < 0.05). CONCLUSIONS: While both stenting methods provide a gradual, controlled decrease in IOP, the double stenting technique was associated with a sooner and greater postoperative reduction in IOP and a good safety profile thanks to fewer HS in the early postoperative period and less need for oral acetazolamide.

Anterior segment changes during accommodation in eyes with a monofocal intraocular lens: high-frequency ultrasound study.

PURPOSE: To analyze anterior segment structure changes during accommodative stimuli after monofocal intraocular lens (IOL) implantation using 2 ultrasound biomicroscopy (UBM) systems. SETTING: Department of Ophthalmology, University of Verona, Verona, Italy. METHODS: Twenty-six eyes (23 patients) with 1 of 4 monofocal IOL types were studied. Five to 9 months postoperatively, the patients were examined by high-frequency UBM using the HiScan system (Optikon 2000 SpA) and UBM 840 system (Carl Zeiss Meditec). Anterior chamber depth (ACD), iris-zonule distance, anterior chamber angle (ACA), scleral-ciliary process angle, and iris-ciliary process angle were measured using both systems. The iris-ciliary process distance and scleral spur perpendicular-sulcus distance were measured with the UBM 840 system and the sulcus-sulcus distance and capsular bag-IOL position with respect to ciliary process apex, with the HiScan system. Two experienced examiners performed all measurements. RESULTS: All parameters except the horizontal iris-ciliary process distance and vertical ACA measured by the UBM 840 system and horizontal ACA by the HiScan system showed significant variation during accommodation. An anterior shift of the IOL-capsular bag ciliary processes--sulcus-zonular iris complex was observed. A simultaneous centripetal shift of ciliary bodies and processes, shown by a reduction in sulcus and capsular bag diameter, was also observed. CONCLUSION: Anterior segment structures demonstrated accommodative movement on UBM after implantation of standard monofocal IOLs.

Long-term Outcomes of a Modified Technique Using the Baerveldt Glaucoma Implant for the Treatment of Refractory Glaucoma.

PURPOSE OF THE STUDY: The purpose of the study was to evaluate the long-term effectiveness and safety profile of Baerveldt glaucoma implant (BGI) in patients with refractory glaucoma operated using a modified technique to avoid postoperative complications. PATIENTS AND METHODS: A total of 160 eyes from 147 glaucomatous patients were enrolled in a consecutive interventional noncomparative case series. All the patients were treated with a 350-mm BGI using a modified technique. Intraocular pressure (IOP), the number of medications, the complications, and the postoperative interventions were reported preoperatively and during the follow-up. Postoperative IOP and the rate of complications were the primary outcome measures. The complete and qualified surgical success was the second endpoint. RESULTS: BGI obtained a mean IOP reduction from 31.8±6.4 mm Hg (baseline) to 14.4±3.5 mm Hg after a mean follow-up period of 38.4±9.6 months. The mean number of medications reduced between preoperative (n=3.17±1.03) and postoperative period (n=0.58±0.83) (P<0.0001). Cumulative probability of maintaining an IOP between 5 and 21 mm Hg and/or a 25% or greater reduction in IOP was 78.7% at 1 year and 72.1% at 4 years, including 39 eyes (24.4%) in which postoperative interventions were required (qualified success). If we exclude those eyes from the analysis, the probability of complete success was 93.4% at 1 year and 91.4% at 4 years in 75.4% of the eyes. CONCLUSIONS: This modified technique achieved a high percentage of surgical success during the whole follow-up time and was effective in preventing the most serious immediate complications of nonvalved tube shunts.

Comparative study of the effects of 2% ibopamine, 10% phenylephrine, and 1% tropicamide on the anterior segment.

PURPOSE: To assess in normal and glaucomatous eyes the effect of the dopaminergic drug 2% ibopamine on visual acuity, IOP, pupil size and anterior segment geometry, compared with 10% phenylephrine and 1% tropicamide. METHODS: Fifteen healthy subjects and 15 patients with primary open-angle glaucoma, aged from 40 to 70 years (mean age: 54.8 +/- 9.6), were recruited into this open prospective study. After instillation of 2% ibopamine, refraction, visual acuity, pupil diameter, IOP, five A-scan ultrasonographic parameters, and 15 ultrasound biomicroscopy parameters were evaluated. The study was repeated with assessment of the same parameters 20 to 30 days later in 10 subjects (5 normal and 5 with glaucoma), using first 10% phenylephrine and then 1% tropicamide. A second group of 15 healthy subjects, aged from 45 to 70 years (mean age: 53.5 +/- 8.6) was examined to evaluate the dose-response effect and time course on pupil diameter, of ibopamine, phenylephrine, and tropicamide. RESULTS: After 40 minutes 2% ibopamine induced a marked mydriatic effect (from 5 to 9.1 mm; P < 0.0001) greater than that produced by 10% phenylephrine (from 4.7 to 7.9 mm; P < 0.0001) or 1% tropicamide (from 4.6 to 6.9 mm; P < 0.0001), with no changes in refraction or visual acuity. IOP was significantly increased only in patients with glaucoma after instillation of either 2% ibopamine (from 22.2 to 24.8 mm Hg; P < 0.0001) or 1% tropicamide (from 21.2 to 23.6 mm Hg; P = 0.004), whereas 10% phenylephrine induced no statistically significant changes. Ibopamine (2%) caused a significant increase in iris thickness with a reduction of the sulcus ciliaris and posterior chamber depth. The anterior chamber angle (ACA) showed a mean 5 degrees widening with an increase in scleral-iris angle (SIA) and sclera-ciliary process angle. In 11 (37%) of 30 cases, separation of the pupil border and lens surface occurred, whereas contact was maintained only with the zonule in the other 19 (63%) of 30. The changes after 10% phenylephrine instillation were similar, although only the increase in iris thickness and SIA was statistically significant. Tropicamide (1%) induced a slight but significant increase in SIA. CONCLUSIONS: The results confirm the potent mydriatic effect of 2% ibopamine, which is greater than that of either 10% phenylephrine or 1% tropicamide, as well as its ability to induce an increase in intraocular pressure when used in patients with glaucoma alone. These data support the hypothesis that the widening of the ACA induced by 2% ibopamine is due to posterior rotation of the iris plane and ciliary processes. These changes are quantitatively greater than those induced by 10% phenylephrine and 1% tropicamide and are related to the greater mydriatic effect of the drug.

Ultrasound biomicroscopic changes during accommodation in eyes with accommodating intraocular lenses: pilot study and hypothesis for the mechanism of accommodation.

PURPOSE: To document ciliary body constriction and movement with the Crystalens AT-45 intraocular lens (IOL) (eyeonics) using ultrasound biomicroscopy. SETTING: Eye Clinic, Department of Neurological and Visual Sciences, University of Verona, Verona, Italy. METHODS: Patients with no preexisting ocular conditions other than cataract who agreed to return for follow-up were considered. Twenty eyes of 14 patients with a best corrected visual acuity of 5/10 or worse and a refractive error (spherical equivalent) of +/-1.0 diopter (D) had implantation of a Crystalens AT-45 accommodating IOL. Six patients had bilateral implantation. Ultrasound biomicroscopy was performed postoperatively at 1 and 6 months. Before and during accommodation, the anterior chamber depth (ACD) was measured to assess the endothelium-IOL distance and measure the scleral-ciliary process angle to determine whether there was anterior rotation of the ciliary body. The uncorrected distance acuity, best corrected distance acuity, uncorrected near acuity, distance corrected near acuity, best corrected near acuity, and accommodative amplitude were determined. Analysis was done to determine whether there was a correlation between the accommodative amplitude and the percentage variation in the ACD and scleral-ciliary process angle. RESULTS: All surgical procedures were uneventful. The mean uncorrected distance acuity at 1 month was 0.8 +/- 0.14 (SD) and remained stable at 6 months. Three of 20 eyes (15%) and 8 of 20 eyes (40%) had a Jaeger acuity of J1 and J3, respectively, without additional power correction. During accommodation, the mean reduction in ACD was 0.32 +/- 0.16 mm at 1 month and 0.33 +/- 0.25 mm at 6 months. The mean narrowing of the scleral-ciliary process angle was 4.32 +/- 1.87 degrees at 1 month and 4.43 +/- 1.85 degrees at 6 months. There was a correlation between accommodative amplitude and a decrease in the ACD (r=0.404) and a decrease in scleral-ciliary process angle (r=0.773). CONCLUSIONS: Anterior displacement of the Crystalens IOL and corresponding anterior rotation of the ciliary body occurred during near vision. The IOL displacement and rotation were proportional to the accommodation capacity.

[Twins in biomedical research and the creation of the "National Twin Registry"]. / I gemelli nella ricerca biomedica e l'istituzione del "Registro Nazionale Gemelli".

Twins are a valuable resource for the study of complex traits. The twin method is substantially based on the comparison between correlations and concordance in monozygotic (MZ) and dizygotic (DZ) twins and allows several applications in biomedical and molecular genetic research. It allows either the qualitative and quantitative evaluation of the influences that genetic and environmental factors exert on phenotypes or the estimation of trait variability. Moreover, classical genetic linkage analysis is more powerful if performed in DZ twins. However, the twin method has some pitfalls, such as the necessity that collected samples be representative of both twin and general population. For this reason, over the last few years, a number of Countries have established population-based twin registers, which guarantee the maximum level of representation and, consequently, are of extreme value for epidemiological studies. Italy is also implementing a national twin register. The following is the description of the procedure that led to the establishment of the Italian Twin Registry.

Multiple sclerosis in twins from continental Italy and Sardinia: a nationwide study.

Knowledge about the balance between heritable and nonheritable risk in multiple sclerosis (MS) is based on twin studies in high-prevalence areas. In a study that avoided ascertainment limitations and directly compared continental Italy (medium-prevalence) and Sardinia (high-prevalence), we ascertained 216 pairs from 34,549 patients. This gives a twinning rate of 0.62% among MS patients, significantly less than that of the general population. In continental Italy, probandwise concordance was 14.5% (95% confidence interval, 5.1-23.8) for monozygotic and 4.0% (95% confidence interval, 0.8-7.1) for dizygotic twins. Results in Sardinia resemble those in northern populations but in limited numbers. Monozygotic concordance was 22.2% (95% confidence interval, 0-49.3) probandwise, but no concordant dizygotic pairs were identified. A questionnaire on 80 items possibly related to disease cause was administered to 70 twin pairs, 135 sporadic patients, and 135 healthy volunteers. Variables positively (7) or negatively (2) associated with predisposition and concordance in twins largely overlapped and were mainly linked to infection. If compared with previous studies, our data demonstrate that penetrance in twins appears to correlate with MS prevalence. They highlight the relevance of nonheritable variables in Mediterranean areas. The apparent underrepresentation of MS among Italian twins draws attention to protective factors, shared by twins, that may influence susceptibility.