The safety of BCG revaccination in the context of COVID-19.

The bacille Calmette-Guérin (BCG) vaccine is administered in many countries as part of their vaccination schedules. Epidemiologic studies have suggested a possible benefit of this vaccine in the context of the COVID-19 pandemic and other respiratory infections. We aimed to assess the safety of this intervention in BCG-primed adults. Adult health care workers (n = 451) received a single intradermal application of the BCG vaccine (Tokyo 172 strain) in the deltoid region of the right arm. Follow-up (30 days) calls and clinical inspections were guided using a standardized data sheet to assess local and systemic reactions. Early local reactions were common at 24 h and 7 days, such as erythema (74.9%, 69.2%), induration (55.7%, 59%), a papule (53.4%, 47.7%), and edema (48.3%, 38.1). Local symptoms (pruritus 44.8%, heat 16.2%, and pain 34.8%) were less frequent at day 7. Late expected reactions (14 and 30 days) included the formation of crusts (39.6% and 63.9%), a pustule (36.6% and 17%), or ulcers (28.8% and 17.7%). Severe reactions were limited to subcutaneous abscesses (2%) and lymphadenitis (<1%).

Retinal Microvascular Density and Perfusion during an Insulin-Induced Hypoglycemia Episode: A Warning Call.

Aim: To evaluate retinal vascular perfusion and density by optical coherence tomography angiography (OCTA) before, during, and after hypoglycemia in individuals with diabetes mellitus with or without diabetic retinopathy (DR). Methods: A focused clinical history was performed, followed by an ophthalmological examination to document retinopathy status. OCTA was performed at baseline, at hypoglycemia, and at glucose normalization. Eye tracking and eye alignment devices on the platform were used to obtain a macular thickness cube (512 × 128) and vascular perfusion and density protocols of 3 × 3 mm. Retinal vascular reactivity was analyzed with superficial plexus vascular perfusion and density protocols on OCTA. Results: Fifty-two participants encompassing 97 eyes fulfilled the eligibility criteria. Their mean age was 42.9 ± 15.1 years (range, 22 to 65), and 20 (38.2%) were men. We found a statistically significant difference in vascular perfusion and density when comparing all groups at baseline. The controls had higher vascular perfusion and density values than the cases. Vascular perfusion and density were significantly reduced in all groups during the hypoglycemia episode, except for vascular density in DR cases. Conclusion: Acute hypoglycemia significantly alters the retinal vascularity in DM patients with and without DR, suggesting that repeated episodes of acute hypoglycemia could exacerbate retinopathy in the long term.

Effects of Sleep Deprivation, Non-Dominant Hand Employment, Caffeine and Alcohol Intake During Surgical Performance: Lessons Learned From the Retina Eyesi Virtual Reality Surgical Simulator.

Purpose: Determine whether real-life surgical experience correlates with scores on a retina virtual simulator and the effects of various challenges on surgical performance. Methods: The study was performed using the Eyesi Surgical Simulator, a virtual reality retina surgical simulator. Residents, fellows, and retina staff were assessed on surgical simulations to determine surgical skills. Participants were assigned baseline scores on speed, efficiency of movement, and ability to avoid retinal damage. After receiving their baseline scores, participants were challenged to use their non-dominant hand or to use the simulator after sleep deprivation or the intake of caffeine or alcohol. Results: At baseline, junior residents had an average score of 943; senior residents, 1045; retina fellows, 1153; and surgical retina staff, 1161. A 12.5% overall improvement in scores was achieved when comparing baseline 1 to baseline 2; a major improvement was recorded in residents (14.5%) compared with fellows and retina staff (9.97%). A statistically significant difference was observed between residents and fellows (P = 0.027), as well as between residents and retina staff (P = 0.04). A significant decrease in performance (15.7%) was observed when the non-dominant hand was used (P = 0.043). Performance after sleep deprivation and alcohol intake decreased, but not with a statistically significant difference (P = 0.6 and P = 0.5, respectively). A trend toward increasing performance was observed after caffeine intake (6.1%; P = 0.06). Conclusions: The retina virtual simulator is a novel teaching tool for retinal surgery. A significant association was observed between real surgical experience and the retina surgery virtual simulator results based on surgical experience. Translational Relevance: An association between real surgical experience and retina surgery virtual simulator results was demonstrated. A complete training program with a cut-off threshold score should be validated for retina training programs.

Treatment burden and perceptions of glucose-lowering therapy among people living with diabetes.

AIMS: Address treatment burden and general perceptions of pharmacological treatment in patients with diabetes. METHODS: We surveyed adult patients with diabetes cared for in a tertiary academic medical center about: i) knowledge about the impact of glucose-lowering medication use on diabetes control and complications, ii) common beliefs about natural medicine and insulin use, iii) attitudes towards glucose-lowering medications, iv) burden of treatment, v) general knowledge of diabetes pharmacological treatment, and vi) perceptions of shared decision-making. RESULTS: Two hundred-four participants completed the survey. While most (90%) agreed that adherence to medication would control diabetes and improve quality of life, 30-40% were not certain that it would translate to fewer disease complications. About one of three thought medications could be harmful (29.4%). Over 50% agreed or was unsure that natural remedies were as good/better than prescribed medications. About 30% acknowledged difficulties taking their diabetes medications and monitoring blood glucose, and over 50% were concerned about treatment costs. Nearly 30% denied receiving a detailed explanation from their clinician regarding their disease and is treatment. CONCLUSIONS: Our results highlight the importance of patient education regarding pharmacological treatment for diabetes, and eliciting sources of distress and treatment burden among patients with diabetes.

VITRECTOMY + TRANSSCLERAL DIODE LASER CYCLOPEXY TREATMENT FOR 360° TRAUMATIC CYCLODIALYSIS AND HYPOTONY MACULOPATHY: CASE REPORT.

BACKGROUND/PURPOSE: To report a surgical approach of combined vitrectomy, gas endotamponade, and transscleral diode laser cyclopexy treatment for hypotony maculopathy induced by traumatic cyclodialysis. METHODS: A case of a 37-year-old male patient with decreased vision in his right eye because of hypotony maculopathy and 360° traumatic cyclodialysis is reported. Patient was initially treated conservatively with topical steroid + cycloplegic eye drops and repeated periocular corticosteroid injections with no improvement in the intraocular pressure and the anatomical defect. The patient underwent 23 G pars plana vitrectomy with 20% SF 6 gas endotamponade and supine position. Transscleral 810-nm laser burns were applied at 1.5 mm from the scleral limbus around the cornea in two confluent rows avoiding the horizontal meridians. Parameters used were 700-1,000 mW of power with a 2-second exposure in a continuous wave mode, and postoperative supine positioning of the head was indicated. RESULTS: Preoperative intraocular pressure improved from 2 mmHg to 10 mmHg at one week after surgical treatment and achieved 16 mmHg at one month to remain stable during a 6 months follow-up period. Presenting visual acuity was 1.0 logMAR (20/200 Snellen) and improved to 0.3 logMAR (20/40 Snellen) at Month 1 and achieved 0.1 logMAR (20/20 Snellen) at the third month. Complete closure of the cyclodialysis cleft and peripheral anterior synechiae formation were also observed at 3 months after treatment, with complete reattachment of the ciliary body demonstrated by ultrasound biomicroscopy and significant improvement of the macular anatomy demonstrated by spectral-domain optical coherence tomography. CONCLUSION: The combination of pars plana vitrectomy, supine positioning with gas endotamponade, and transscleral laser cyclopexy can successfully improve the visual and anatomical outcomes in patients with hypotony maculopathy and 360° traumatic cyclodialysis.

Autofluorescence indexes as biomarkers for antiangiogenic loading dose outcome in diabetic macular edema.

PURPOSE: To evaluate the combination of fundus autofluorescence results with several clinical and structural variables into mathematical indexes to enhance their ability to predict visual and anatomical changes after the antivascular endothelial growth factor loading dose. METHODS: Patients with diabetic macular edema were enrolled. Each patient had a comprehensive ophthalmological examination, contrast sensitivity, optical coherence tomography, and fundus autofluorescence assessment. All patients received three monthly doses of ziv-aflibercept and were followed each month for response assessment. Autofluorescence was classified according to its level into five grades. The grades were combined with other variables (best-corrected visual acuity, contrast sensitivity, central macular thickness, macular cube volume, and macular cube average thickness) into normalized indexes. Statistical assessment was done using a Spearman's rank correlation coefficient, linear regression, and interobserver-agreement analysis. RESULTS: There was a strong correlation between the fundus autofluorescence/baseline best-corrected visual acuity index and the fundus autofluorescence/contrast-sensitivity index at baseline with the best-corrected visual acuity after the third dose of ziv-aflibercept (rs = -0.78, p = .000 and rs = -0.68, p = .0009 respectively). The fundus autofluorescence/baseline best-corrected visual acuity index and the fundus autofluorescence/contrast-sensitivity index, both at baseline had a mild correlation with the macular volume at 1 month of follow-up (rs = 0.56, p = .008 and (rs = 0.64, p = .002, respectively). CONCLUSION: This study suggests that it is possible to combine fundus autofluorescence results with functional and structural variables into normalized indexes that could potentially predict outcomes after antivascular endothelial growth factor loading dose in patients with diabetic macular edema.

Optimizing Visual Performance With Digitally Assisted Vitreoretinal Surgery.

BACKGROUND AND OBJECTIVE: Evaluate depth of field (DOF) and lateral resolution (LR) on digitally assisted vitreoretinal surgery (DAVS) with different camera aperture values and TV viewing distances to determine maximal optical performance. PATIENTS AND METHODS: Five retinal surgeons objectively evaluated DOF and LR at low (10×), medium (15×), and high (20×) magnification on a conventional microscope (CM) and DAVS. DAVS was evaluated at different camera apertures (30%, 50%, and 75%) and TV viewing distances (1.2 meters [m], 1.5 m, and 2.0 m). A comparison between CM and optimized DAVS values was carried out. RESULTS: On DAVS, DOF significantly increased as camera aperture size was reduced (75% to 50%, P = .022; 75% to 30%, P ≤ .001; and 50% to 30%, P = .001) and as microscope magnification was reduced (high to medium, P = .009; high to low, P ≤ .001; and medium to low, P = .002). LR significantly increased as microscope magnification was increased (low to medium, P = .010; low to high, P ≤ .001; and medium to high, P = .015) and as TV display distance decreased (2.0 m to 1.5 m, P = .019; 2.0 m to 1.2 m, P = .009; and 1.5 m to1.2 m, P = .185). When comparing optimized DAVS against CM, DOF was significantly larger on DAVS (P = .019). LR on DAVS outperformed the CM, but statistical significant was not reached (P = .185). CONCLUSIONS: The authors' study is the first to evaluate different aperture, magnification, and TV distance settings, and when optimized, DAVS can significantly outperform a CM with respect to DOF and LR. Optimized visual performance for DAVS is obtained with a 30% camera aperture and a TV viewing distance no further than 1.5 m. Maximal microscope magnification to exploit LR during macular surgery and low-to-medium magnification to increase DOF for overall vitrectomy surgery is recommended. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:S15-S21.].

ECTOPIC INNER FOVEAL LAYER CLASSIFICATION SCHEME PREDICTS VISUAL OUTCOMES AFTER EPIRETINAL MEMBRANE SURGERY.

PURPOSE: To evaluate the ectopic inner foveal layer (EIFL) staging scheme as a visual prognostic factor for patients undergoing epiretinal membrane (ERM) surgery. METHODS: Retrospective study of 88 pseudophakic patients with diagnosis of idiopathic ERM who underwent ERM surgery with a minimum follow-up of 12 months. Preoperative and postoperative EIFL staging was correlated with the final best-corrected visual acuity (BCVA). As a secondary outcome, evaluation of the proportion of patients achieving final best-corrected visual acuity ≥20/40 in each stage was assessed. RESULTS: Based on the EIFL staging scheme, of 88 pseudophakic eyes analyzed, 24 (27.4%) were diagnosed as Stage 2 ERM, 45 (51.1%) as Stage 3 ERM, and 19 (21.5%) as Stage 4 ERM preoperatively. At the final follow-up visit, 70.8% of eyes with Stage 2 showed an improvement in EIFL staging scheme, while 68% of eyes in Stage 3 and 4 remained the same. The final best-corrected visual acuity significantly improved with all EIFL stages (P = <0.05). However, earlier stages were associated with better visual outcomes both preoperatively and postoperatively (Stage 2 > Stage 3 > Stage 4 P < 0.001). Final best-corrected visual acuity ≥20/40 was reached in 91.7% of eyes with Stage 2, 42.3% with Stage 3, and 5.2% with Stage 4. CONCLUSION: The EIFL staging scheme is an easy, fast, and reproducible method to evaluate visual prognosis with ERM surgery. Surgery on Stage 2 ERM results in significantly better visual outcomes and a greater chance of reversibility in anatomical changes.

Oxymetazoline: reduction of subconjunctival hemorrhage incidence after intravitreal injections.

OBJECTIVE: Subconjunctival hemorrhage (SCH) is an important minor side effect that might affect patient compliance to antivascular endothelial growth factor (anti-VEGF) intravitreal injection treatment (IVI). We sought to compare SCH incidence and pain score responses after topical oxymetazoline in naïve patients undergoing a single IVI of ranibizumab for diabetic macular edema. METHODS: Prospective, randomized, double-blinded, single centre study. One hundred two patients naïve to anti-VEGF were assigned to receive either topical oxymetazoline or placebo 30 minutes before IVI. SCH incidence and area were measured by slit lamp 24 hours after, and pain was evaluated 5 minutes and 24 hours after. RESULTS: SCH incidence was reported on 72% in control group versus 51% in oxymetazoline group (p = 0.037). Mean size of SCH was 16.82 mm2 in control group versus 12.55 mm2 in oxymetazoline group (p = 0.394). Prevalence of local pain in the overall study population was 60%. No significant statistical difference was achieved between groups 5 minutes or 24 hours after IVI in either pain scale evaluation. CONCLUSION: Administration of topical oxymetazoline 30 minutes before IVI is a single, harmless, cost-effective intervention that decreases the incidence of subconjunctival hemorrhage. This may considerably improve patient treatment satisfaction and promote compliance to IVI therapy.

Posterior polar annular choroidal dystrophy association with cystoid macular edema.

Posterior polar annular choroidal dystrophy (PPACD) is an uncommon retinal dystrophy causing nyctalopia. PPACD has been characteristically described as a foveal sparing dystrophy. We report the first case with cystoid macular edema association.

Topical steroids: A non-surgical approach for recurrent macular holes.

PURPOSE: Report a case of a recurrent macular hole which completely resolved with a non-surgical approach with steroid drops. OBSERVATIONS: While traction is considered the mayor contributor to full thickness macular hole formation, retinal hydration as that in cystoid macular edema also plays an important role. CONCLUSIONS AND IMPORTANCE: Topical corticosteroid drops can be considered as an alternative therapy for small recurrent macular holes that lack tractional components and have an appearance of cystoid changes on the edges of the hole.

Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Sub-hyaloid and sub-internal limiting membrane macular hemorrhage after laser exposure at music festival: a case report.

PURPOSE: To describe the first case of a combined sub-hyaloid and sub-internal limiting membrane macular hemorrhage after recreational laser exposure. METHODS: A 23-year-old patient presented with an acute loss of vision in his right eye (OD) immediately after a brief exposure to a laser beam at a music festival. Color photography, spectral-domain optical coherence tomography (SD-OCT), and multifocal electroretinogram (mfERG) were performed for diagnosis and follow-up. RESULTS: On presentation, visual acuity was 20/400 in the OD and 20/20 in the left eye. Posterior segment examination of his OD revealed a preretinal hemorrhage at the macula. SD-OCT images exposed a combined sub-hyaloid and sub-internal limiting membrane localization. Successful VPP with ILM peeling was carried out. Although sequential mfERG displayed almost complete restoration of the P1 amplitude 6 months posterior to VPP, SD-OCT demonstrated permanent damage to outer retinal layers. Final BCVA on OD was 20/30. CONCLUSION: The expanding and unregulated use of lasers in everyday life has created an increasing amount of cases of laser-induced retinopathy in recent years. Much more attention should be addressed in laser safety and awareness to prevent future ocular injuries. In acute phases of sub-hyaloid hemorrhages blocking direct visualization of the posterior pole, mfERG is a valuable tool to address initial macular pathology.

Single-Spot Yellow Laser Versus Conventional Green Laser on Panretinal Photocoagulation: Patient Pain Scores and Preferences.

BACKGROUND AND OBJECTIVE: Panretinal photocoagulation (PRP) is the mainstay therapy for proliferative diabetic retinopathy. Pain during and after its application is a complication that affects patients' therapeutic adherence. This study aimed to compare pain perception and patient preference for the 577-nm yellow laser (YL-577) (LIGHTL as 577; LIGHTMED, San Clemente, CA) and the conventional 532-nm green laser (GL-532) (Purepoint Laser; Alcon, Fort Worth, TX) with PRP. PATIENTS AND METHODS: A total of 92 patient eyes with proliferative diabetic retinopathy treated with PRP were randomly assigned to receive both GL-532 and YL-577 (184 eyes) - one on each eye, with the order of application randomized, as well. Afterward, verbal rapid answer and visual analogue scale (VAS) scores for pain perception and patient preference were evaluated. RESULTS: VAS score was 7 ± 2 for the GL-532 group compared to 5 ± 3 in the YL-577 group (P = .001). Overall, 75% of the patients preferred YL-577 therapy if they were to receive a second PRP session. CONCLUSION: The use of YL-577 as an alternative approach for PRP reduces pain perception and is preferred by patients. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:902-905.].

Riley-Day Syndrome in a Hispanic Infant of Non-Jewish Ashkenazi Descent.

Riley-Day syndrome is an autosomal recessive sensory and autonomic neuropathy. Patients present a lack of fungiform papilla, alacrima and usually feeding difficulties. It is present almost exclusively in Ashkenazi Jewish individuals and has a poor prognosis. We describe an unusual case of Riley-Day syndrome with pseudostrabismus in a non-Ashkenazi Jewish patient. A one-year-old female infant was referred for evaluation of strabismus, absence of fungiform papillae, feeding difficulty, gastroesophageal reflux and episodes of self-mutilation. Deep tendon reflexes were depressed, the blinking rate and corneal reflex were diminished as well and corneas were opaque due to corneal erosions. Reduced lacrimal production was confirmed by the Schirmer test. Eye drops were recommended every 2-3 hours for corneal erosion and the patient was referred to the genetics department for further diagnostic confirmation.

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study.

BACKGROUND: There is scarce scientific information assessing participants' perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. METHODS: To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. RESULTS: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants' health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. CONCLUSION: Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions.

Glucocorticoid functional reserve in full-spectrum intensity of primary hypothyroidism.

Adrenal function might be impaired in patients with primary hypothyroidism. The objective was to evaluate adrenocortical function using the low-dose cosyntropin test in patients with primary hypothyroidism. Consequently a prospective, longitudinal, controlled study of sixty adult patients with primary hypothyroidism was carried out. Patients naïve to L-T4 treatment were compared with control participants. A low-dose cosyntropin test was done before and after L-T4 therapy. Thirty and sixty minutes after the low-dose cosyntropin, the mean cortisol values were lower in the cases group (612.6 ± 133.1 and 603.4 ± 153.7 nmol/L) when compared to the control group (677.0 ± 82.4 and 669.9 ± 83.7 nmol/L) (P = 0.001 and 0.003), respectively. After L-T4 therapy, this difference was lost. Four out of 60 cases (6.7%) taking a cortisol cutoff value of 500 mmol/L and 11 out of 60 (18.3%) having 550 mmol/L as the cutoff had adrenal insufficiency before L-T4 therapy. After L-T4 therapy, 50% and 81% of the cases had normal cortisol response. In conclusion, patients with different degrees of intensity of primary hypothyroidism had improved cortisol response after reaching euthyroidism. The incidence of adrenal insufficiency was 6.7-18.3% and more than 50% of the cases had a normal cortisol response after L-T4 therapy.

Dacryops in the setting of a Boston type II keratoprosthesis.

Dacryops of the lacrimal tissue can develop under diverse circumstances. Recent evidence suggests that scarring or obstruction of the lacrimal ducts may lead to their dilatation and formation of a cystic structure. Patients who undergo repeated orbital surgery may therefore be at greater risk of dacryops formation. In this report, a patient who underwent multiple corneal and glaucoma procedures including Boston type II keratoprosthesis, after acid burns to both eyes, is described. Over time, a fluid-filled collection developed in the lower orbit. On surgical exploration and incision, fluid was drained from a cystic lesion which abutted the lacrimal gland and spanned the upper and lower orbits. The lesion was removed and was proven by histopathology and immunohistochemistry to be dacryops. This is the first known case of dacryops associated with Boston type II keratoprosthesis.