Effectiveness of Mp-3 Microperimetric Biofeedback Fixation Training For Low Vision Rehabilitation in Patients Treated With Corticosteroid Ivt in Retinal Vein Occlusions.

Background: The success of fixation training using microperimetric biofeedback (MP-3 MBFT) in the realm of visual rehabilitation for patients with central vision loss caused by macular pathologies is well established. This study aimed to assess the effectiveness and safety of visual rehabilitation with microperimetric biofeedback in consolidating the benefits obtained, with the goal of reducing the need for repeated intravitreal injections (IVT). Specifically, the focus is on the eyes of patients with central vision loss treated with slow-release corticosteroid IVT following retinal venous thrombosis (RVO), aiming to enhance and maintain postoperative efficacy. Methods: This retrospective review involved the examination of 44 eyes affected by macular edema due to RVO associated with central vision loss. Patients were divided into two groups, with only one undergoing ten sessions of 10-minute visual rehabilitation with a microperimeter (MP-3 MBFT) after IVT over a period of 20 weeks. Results: All the treated patients demonstrated good tolerance to the procedure, with no reported complications. A comparison of best-corrected visual acuity (BCVA), retinal sensitivity recorded with a microperimeter, and pre-IVT fixation stability revealed statistically significant improvements at the end of the first month after IVT. However, the treatment group continued to exhibit superior and more enduring results at four months post-IV. Conclusion: The synergistic use of MP-3 MBFT rehabilitation after IVT with slow-release corticosteroids has proven particularly effective in improving BCVA and long-term fixation stability. This led to a significant reduction in the number of required IVTs, with no related adverse events. The authors argue that biofeedback utilization represents a noninvasive therapeutic option devoid of contraindications and easy to implement and that it positively contributes to the overall patient experience regarding quality of life in advanced stages of macular diseases.

Trace Element Concentration in the Blood and Aqueous Humor of Subjects with Eye Cataract.

Cataract, characterized by the opacification of the lens, is the leading cause of reversible blindness and visual impairment globally. The study aims to investigate the role of trace elements such as Cd, Co, Cr, Cu, Fe, Hg, Mn, Ni, Pb, Se, and Zn in the development and severity of cataract. Elements were quantified by inductively coupled plasma mass spectrometry in blood and aqueous humor of 32 cataract cases and 27 controls living in the Latium region, Italy. The association between element concentration in blood and aqueous humor and cataract severity, gender, and age of subjects were also assessed. Results showed Cr levels significantly elevated in both blood and aqueous humor of cataract cases, with concentrations that increased with cataract severity. In addition, blood Pb levels were significantly higher in older cases and positively correlated with the age of cataract cases, while blood Co and Cu levels negatively correlated with cataract severity, suggesting changes in the levels of these elements. In conclusion, this study provides evidence of the involvement of specific elements in cataract development and severity, and the findings highlighted important avenues for future research. Understanding the biological mechanism underlying element-induced cataract may contribute to preventing cataractogenesis and providing targeted interventions.

Alteration Ocular Motility in Retinitis Pigmentosa: Case-Control Study.

Purpose: To evaluate ocular motility (OM) disorders and strabismus in a sample of patients with retinitis pigmentosa (RP) and a control sample. Methods: In this cross-sectional retrospective analysis, we studied a sample of RP patients with a mean age of 48.74 years and an average visual acuity of 7/10 based on Snellen optotype and a sample of control patients with similar mean age (49 years [men], 47 years [women]) and sex and an average visual acuity of 9.9/10, with the aim of assessing correlations between alteration of OM and strabismus in RP patients based on age, high refractive defect, or severely impaired binocular vision. The examination followed a protocol of testing for anamnesis and best-corrected visual acuity, as well as a complete eye examination, corneal reflex, cover test, OM, Hess screen, and Lang test. Results: At the first orthoptic evaluation, 45.16% of patients showed strabismus, 41.93% exotropia (25% of cases intermittent), 3.22% esotropia, and 6.45% vertical deviation. Later evaluation showed strabismus in 25.80% of patients, exotropia in 19.35% (9.67% intermittent), esotropia in 3.22%, and vertical deviation in 3.22%. Assessment of eye motility study showed 51.6% overaction of the inferior oblique and hypofunction of the superior rectus, and 18% overaction of the lateral rectus and hypofunction of the medial rectus. According to our results, alterations in OM and strabismus in RP patients are not correlated with age or high refractive defect. Therefore, motility disorders and strabismus are attributed to a genetic factor to which men are more susceptible. Conclusion: The incidence of OM disorder was 77.42%, and strabismus was present in 45.16% of patients.

Gene Therapy in Hereditary Retinal Dystrophies: The Usefulness of Diagnostic Tools in Candidate Patient Selections.

PURPOSE: Gene therapy actually seems to have promising results in the treatment of Leber Congenital Amaurosis and some different inherited retinal diseases (IRDs); the primary goal of this strategy is to change gene defects with a wild-type gene without defects in a DNA sequence to achieve partial recovery of the photoreceptor function and, consequently, partially restore lost retinal functions. This approach led to the introduction of a new drug (voretigene neparvovec-rzyl) for replacement of the RPE65 gene in patients affected by Leber Congenital Amaurosis (LCA); however, the treatment results are inconstant and with variable long-lasting effects due to a lack of correctly evaluating the anatomical and functional conditions of residual photoreceptors. These variabilities may also be related to host immunoreactive reactions towards the Adenovirus-associated vector. A broad spectrum of retinal dystrophies frequently generates doubt as to whether the disease or the patient is a good candidate for a successful gene treatment, because, very often, different diseases share similar genetic characteristics, causing an inconstant genotype/phenotype correlation between clinical characteristics also within the same family. For example, mutations on the RPE65 gene cause Leber Congenital Amaurosis (LCA) but also some forms of Retinitis Pigmentosa (RP), Bardet Biedl Syndrome (BBS), Congenital Stationary Night Blindness (CSNB) and Usher syndrome (USH), with a very wide spectrum of clinical manifestations. These confusing elements are due to the different pathways in which the product protein (retinoid isomer-hydrolase) is involved and, consequently, the overlapping metabolism in retinal function. Considering this point and the cost of the drug (over USD one hundred thousand), it would be mandatory to follow guidelines or algorithms to assess the best-fitting disease and candidate patients to maximize the output. Unfortunately, at the moment, there are no suggestions regarding who to treat with gene therapy. Moreover, gene therapy might be helpful in other forms of inherited retinal dystrophies, with more frequent incidence of the disease and better functional conditions (actually, gene therapy is proposed only for patients with poor vision, considering possible side effects due to the treatment procedures), in which this approach leads to better function and, hopefully, visual restoration. But, in this view, who might be a disease candidate or patient to undergo gene therapy, in relationship to the onset of clinical trials for several different forms of IRD? Further, what is the gold standard for tests able to correctly select the patient? Our work aims to evaluate clinical considerations on instrumental morphofunctional tests to assess candidate subjects for treatment and correlate them with clinical and genetic defect analysis that, often, is not correspondent. We try to define which parameters are an essential and indispensable part of the clinical rationale to select patients with IRDs for gene therapy. This review will describe a series of models used to characterize retinal morphology and function from tests, such as optical coherence tomography (OCT) and electrophysiological evaluation (ERG), and its evaluation as a primary outcome in clinical trials. A secondary aim is to propose an ancillary clinical classification of IRDs and their accessibility based on gene therapy's current state of the art. MATERIAL AND METHODS: OCT, ERG, and visual field examinations were performed in different forms of IRDs, classified based on clinical and retinal conditions; compared to the gene defect classification, we utilized a diagnostic algorithm for the clinical classification based on morphofunctional information of the retina of patients, which could significantly improve diagnostic accuracy and, consequently, help the ophthalmologist to make a correct diagnosis to achieve optimal clinical results. These considerations are very helpful in selecting IRD patients who might respond to gene therapy with possible therapeutic success and filter out those in which treatment has a lower chance or no chance of positive results due to bad retinal conditions, avoiding time-consuming patient management with unsatisfactory results.

Topical antibiotic prophylaxis before intravitreal injections: a pilot study.

PURPOSE: To explore whether topical antibiotic prophylaxis in patients scheduled for intravitreal injections achieves surface sterility in a greater proportion of subjects as compared to povidone-iodine alone. MATERIAL AND METHODS: A randomized, triple-blind clinical trial. POPULATION: patients scheduled for intravitreal injections for maculopathy. INCLUSION CRITERIA: any sex and race, age 18 years and above. Subjects were randomized into 4 groups: the first group applied chloramphenicol (CHLORAM), the second netilmicin (NETILM), the third a commercial ozonized antiseptic solution (OZONE), and the fourth applied no drops (CONTROL). OUTCOME VARIABLE: percentage of non-sterile conjunctival swabs. Specimens were collected before and after the application of 5% povidone-iodine moments before the injection. RESULTS: Ninety-eight subjects (33.7% females, 64.3% males), mean age: 70.2 ± 9.3 years (54-91). Before povidone-iodine, both the CHLORAM and NETILM group showed a lower percentage of non-sterile swabs (61.1% and 31.3% respectively), as compared to the OZONE (83.3%) and CONTROL (86.5%) groups (p < .04). However, this statistical difference was lost after the application of povidone-iodine for 3 min. Percentage of non-sterile swabs in each group after applying 5% povidone-iodine: CHLORAM 11.1%, NETILM 12.5%, CONTROL 15.4%, OZONE 25.0%. This was not statistically significant (p > .05). CONCLUSIONS: Topical antibiotic prophylaxis with chloramphenicol or netilmicin drops decreases the bacterial load on the conjunctiva. However, after the application of povidone-iodine, all groups showed a significant reduction in the percentage of non-sterile swabs, and this value was comparable among all groups. For this reason, authors conclude that povidone-iodine alone is sufficient and prior topical antibiotic prophylaxis is not indicated.

Effect of COVID-19 lockdown on refractive errors in Italian children aged 5-12 years: A multi-center retrospective study.

PURPOSE: to explore the potential consequences of the COVID-19 lockdown on the prevalence of myopia among Italian children aged 5-12 years. MATERIALS AND METHODS: retrospective multicenter study conducted in Italy. Population: children aged 5-12. Selection: random selection of children who received an eye exam between 2016 to 2021. Inclusion criteria: healthy children presenting for a routine eye exam. Exclusion criteria: presence of ocular comorbidities other than refractive error, such as blepharoptosis, media opacities, corneal or retinal dystrophies, strabismus, amblyopia, or concurrent therapy with atropine 0.01%. Outcome measure: age and spherical equivalent (SE) measured in diopters (D) in the right eye (RE) in cycloplegia. Statistical analysis: ANOVA test. RESULTS: total of 803 children. In the years prior to COVID-19, the mean SE ± SD of healthy age-school children was: 0.54 ± 1.49 D in 2016; 0.43 ± 1.84 D in 2017; 0.34 ± 1.41 D in 2018; 0.35 ± 1.75 D in 2019 (ANOVA, p = .659). In 2021, the mean SE changed to -0.08 ± 1.44 D (ANOVA, p = .005). Mean age was comparable in all groups (ANOVA, p = .307). The prevalence of myopes (SE ≤-0.5D) and hyperopes (SE ≥ 2D) was respectively 24.10% and 9.64% among children aged 60-96 months, and 63.86% and 6.02% among children aged 97-144 months. These values represent a statistically-significant increase in the number of myopes (Chi-square, p = .016) and decrease in the number of hyperopes (Chi-square, p = .001), as compared to previous years (.06 and.48 respectively). CONCLUSION: this retrospective study shows a statistically-significant decrease in the mean SE in children aged 5-12 in the year following the COVID-19 lockdown. The percentage of myopes has increased significantly, while the percentage of hyperopes has decreased. The lifestyle changes caused by the lockdown led children to spend more time on near-work activities and digital devices, and less time outdoors. These are known risk factors for the development and progression of myopia. Studies in different countries are encouraged.

Risk factors in central retinal vein occlusion: A multi-center case-control study conducted on the Italian population : Demographic, environmental, systemic, and ocular factors that increase the risk for major thrombotic events in the retinal venous system.

PURPOSE: To explore the risk factors for central retinal vein occlusion (CRVO) by comparing a large sample of patients with healthy controls. MATERIALS AND METHODS: Multi-center case-control study. The study group includes patients affected by central retinal vein occlusion, confirmed angiographically, aged 50 years old or above (Group A). The control group includes healthy subjects without an history of retinal vein occlusion (Group B). Outcome measures: age, gender, active smoking, presence of uncontrolled arterial hypertension (uHTN), presence of the following comorbidities: diabetes mellitus type II (DMII), chronic liver disease (CLD), chronic kidney disease (CKD), thyroid disease (TD), systemic lupus erythematosus (SLE), hyperhomocystenemia (HHcy), dyslipidemia (DLip), carotid artery disease (CAD), glaucoma, atrial fibrillation (AF), migraine headache (MH), chronic obstructive pulmonary disease (COPD), obstructive sleep apnea syndrome (OSAS), history of myocardial infarction (MI). Odds-ratios were calculated with logistic regression analysis. RESULTS: A total of 203 patients (Group A) and 339 controls (Group B). Statistically-significant differences were found for the following variables: age (OR: 1.109 [1.081-1.138], p < .001), active smoking (OR: 2.048 [1.210- 3.466], p < .008), DMII (OR: 4.533 [2.097-9.803], p < .001), HHcy (OR: 4.507 [2.477-10.001 ], p < .001), DLip (OR: 2.255 [1.352-3.762], p = .002), CAD (OR: 6.632 [2.944- 14.942], p < .001), glaucoma (OR: 4.656 [2.031-10.673], < .001), OSAS (OR: 1.744 [1.023-2.975], < .041), uHTN (OR: 3.656 [2.247-5.949], < .001). No statistically-significant differences were found for the other variables. CONCLUSIONS: Older age, active smoking, as well as presence of DMII, HHcy, DLip, CAD, glaucoma, OSAS, and uHTN, all increase the risk for CRVO. A comprehensive assessment of patients with CRVO is paramount. Adequate control of all the aforementioned risk factors is likely of great significance in reducing the incidence of CRVO among the general population, and it likely plays an important role in improving the prognosis following the occlusive event.

Utility of Ocular Motility Tests in Orbital Floor Fractures with Muscle Entrapment That is Not Detected on Computed Tomography.

PURPOSE: Determine the usefulness of ocular motility testing to detect the presence of muscle entrapment. MATERIALS AND METHODS: Cross-sectional study of patients with symptoms of diplopia secondary to facial trauma. Inclusion criteria: age between 20 and 80 years; symptoms of diplopia following facial trauma; presence of orbital floor fracture confirmed radiologically; presence of muscle entrapment confirmed at the time of surgery; best-corrected visual acuity of 0.6 or more. Exclusion criteria: muscle entrapment visible on computed tomography; candidate for immediate surgical correction; prior history of strabismus surgery. Outcome measures: Abnormal Head Position (AHP), Hirschberg Corneal Reflexes (CR), Cover/Uncover and Alternating Cover Test, Hertel exophthalmometry, Near Point of Convergence (NPC), Kestenbaum Limbus test, Red Filter test, and Hess screen test. RESULTS: Forty-six subjects (38 males, 8 females, mean age 27 ± 3.3 SD years). Pre-operative assessment: forty-six (100%) reported diplopia on the Red Filter test and showed some degree of abnormality on the Hess Screen test. Forty-two (91%) showed AHP. Forty-one (89%) had exophthalmometry values that differed 2 mm or more between the two eyes and insufficient NPC. Thirty-two (69.6%) showed deficits of 3 mm or more on the Kestenbaum Limbus test. Sixteen (35%) had abnormal Hirschberg corneal reflexes. Eleven (24%) demonstrated constant or intermittent strabismus. CONCLUSION: Ocular motility testing can differentiate non-invasively, pre-operatively, and cost-effectively the presence of muscle entrapment even when this is not visible on computed tomography.

Efficacy and safety of intravitreal Fluocinolone Acetonide microimplant (ILUVIEN®) in patients with chronic diabetic macular edema: 1 year follow-up.

PURPOSE: Evaluate the efficacy and safety of intravitreal 0.19 mg fluocinolone acetonide (FAc) micro implant in patients with chronic diabetic macular edema (cDME). METHODS: Prospective study recruiting subjects with cDME. Inclusion criteria: cDME for at least 2 years documented with OCT imaging; pseudophakia; previous treatments with laser photocoagulation and intravitreal injections of anti-VEGF and/or dexamethasone. Exclusion criteria: phakia; ocular hypertension; tractional component visible on OCT; glaucoma; previous vitrectomy. Outcome measures included best-corrected visual acuity (BVCA), intraocular pressure (IOP), and central macular thickness (CMT), measured 1, 3, 6, and 12 months post-injection. Data were compared with the Friedman test and significance was set at p < 0.05. RESULTS: A total of 18 eyes with a median duration of cDME of 45 months (25-118 months). The 77% of subjects either maintained or improved their BVCA. About 17% and 33% of subjects showed an improvement of 15 ETDRS letters or more at 3 and 12 months respectively. The 17% and 28% of subjects showed a CMT <250 microns at 3 and 12 months, respectively. The median change in CMT thickness was of -370 and -373.5 microns at 3 and 12 months post-injection respectively (p-value is 0.025). Changes in median IOP at 3 and 12 months post-injection were not statistically significant (p-value is 0.210). Ocular hypertension (OHT) was detected in two eyes (11%). CONCLUSION: The FAc micro implant has proved efficacy in improving and/or maintaining BVCA in 77% of patients with cDME up to 12 months post-injection. Ocular hypertension is the most common side effect but responds well to topical therapy.

Effects of Repeated Intravitreal Injections of Dexamethasone Implants on Intraocular Pressure: A 4-Year Study.

PURPOSE: Dexamethasone and other corticosteroids are administered intravitreally to treat a variety of retinal diseases. As a side effect, they can alter intraocular pressure (IOP). The purpose of this study is to describe the incidence, severity, and management of ocular hypertension following the administration of multiple intravitreal injections of dexamethasone implants. MATERIALS AND METHODS: A total of 78 eyes of 78 subjects (males 62%; females 38%; mean age 67 ± 13 years SD) received a total of 152 intravitreal injections of 0.7 mg dexamethasone implants over 4 years. Indications included retinal vein occlusion (87%), diabetic macular edema (9%), wet-type age-related macular degeneration (4%). Ocular hypertension was defined as intraocular pressure above 23 mmHg or any pressure increase of 10 mmHg or more from baseline values. IOP was measured by applanation tonometry before the injection (T0), as well as one week (T1), one month (T2), and three months (T3) afterwards. RESULTS: Five percent (4/78) of subjects developed ocular hypertension after the 1st injection. On the second and third rounds, additional 7.2% (3/42) and 4.2% (1/24) of subjects developed the same side effect. Among the 8 subjects who received a fourth injection, none was found with OHT. Pressure elevations were detected at T2 and T3. In all patients, topical medical therapy was sufficient to lower the IOP below threshold. Mean pressure variations following the first injection as compared to previous recorded values were +0.97 mmHg (T1), +0.92 mmHg (T2), and -0.41 mmHg (T3) (p < 0.05). Mean pressure variations following the second injection were +0.54 mmHg (T1), +0.23 mmHg (T2) and -0.66 mmHg (T3) (p < 0.05). CONCLUSION: Ocular hypertension is a recognized side effect of intravitreal dexamethasone. Some patients develop it right after the first injection, while others develop it subsequently, on the 2nd or 3rd round. This side effect becomes most apparent 30-90 days following the implantation procedure and responds well to topical pressure-lowering medications.