Bluetooth Noise-Canceling Headphones Improve the Quality of Ophthalmic Exams in Patients With Hearing Loss: A Randomized Controlled Trial.

INTRODUCTION: This study tests the utilization of Bluetooth noise-canceling headphones in improving the quality of eye exams in patients with hearing loss. This prospective study was approved on ethical standards by the University of Texas Medical Branch (UTMB) Institutional Review Board (Approval No. 22-0079) and registered with the National Institutes of Health (NCT05420038). METHODS: UTMB patients above 55 years of age were screened for hearing loss using soundcheck audiometry. Twenty-nine subjects answered pre-recorded ophthalmic exam questions that solicited precise responses. As controls, subjects were randomly administered half of the questions via headphones and half via a smartphone at normal speech volume (60 decibels). Points were awarded for responses demonstrating comprehension, and a post-exam survey was collected. RESULTS: Collectively, the mean score was 1.79 with headphones versus 0.96 with control on the Amsler grid segment and 1.90 with headphones versus 0.97 with control on education questions (p=0.001). Between red zone and yellow zone hearing loss patients, the more severe red zone group answered significantly better in both Amsler (1.78 versus 0.50; p=0.0003) and education questions (1.88 versus 0.44; p<0.0001) with headphones. The yellow zone group answered better with headphones overall but failed to reach significance. Post-exam survey indicated that 28 of 29 patients (97%) preferred the headphones during ophthalmic exams. CONCLUSION: Patients with hearing loss demonstrated better comprehension with Bluetooth headphones. These low-cost devices show great promise at improving effective, compassionate communication between providers and hearing loss patients.

Late Iris Cerclage Suture Cheese-Wiring.

PURPOSE: Mydriatic pupil repair by cerclage has been thought to be a permanent fix for glare, visual function and cosmesis. Iris repair can develop late cheese-wiring of cerclage sutures with resultant loss of benefits. We describe a case series of cerclage failures due to cheese-wiring. SETTING: Cincinnati Eye Institute, Cincinnati, Ohio. DESIGN: Retrospective single-surgeon case series. METHODS: A retrospective chart review sought patients that underwent iris cerclage at the Cincinnati Eye Institute who later developed suture cheese-wiring. The patient symptoms, demographics, cerclage size, suture type, knot type, iris status, and suture status at final follow up were ascertained. RESULTS: Six cases of cerclage suture cheese-wiring with loss of the original surgical benefit were identified. 10-0 polypropylene suture and a 3-1-1 knot were utilized in each case. The suture remained intact with an intact knot and suture loop in all cases. CONCLUSION: Cheese-wiring with return of mydriasis is a potential long-term outcome of iris cerclage suture placement, with return of pre-operative symptoms. Awareness of this potential eventuality provides physicians and patients a broader perspective when selecting between cerclage suture, iris prosthesis placement or other surgical and non-surgical options.

Novel tactile bottle neck adaptor facilitates eye drop adherence in visually impaired patients.

PURPOSE: To test the use of Ring-IT, a novel 3D tactile bottle neck adaptor in topical eye drop adherence in visually impaired patients. METHODS: Bottle neck ring adaptors with either one, two or three protrusions with cube or sphere endings were designed. In phase 1, low vision was simulated in healthy subjects (n=20) with a 20/200 vision simulator; while in phase 2, visually impaired patients (n=26; 20/70 or worse) were recruited. Subjects were randomised to six combinations of varying protrusions and shapes on medication bottles and asked to identify these traits at different presentations. Responses and time to identify were recorded. RESULTS: Phase 1: 98.3% of subjects correctly identified the number of protrusions. Mean time to identify was 4.5±6.1 s. Identification success for cube and sphere end pieces were 91.7% and 73.3%, with average time for identification of 9.9±7.6 and 10.9±9.0 s. In phase 2, 92.3% of subjects correctly identified the number of protrusions. Mean time to identify was 6.0±3.0 s. Identification success for cube and sphere end pieces were 78.2% and 74.4%; with average time for identification of 7.5±4.8 and 8.5±5.6 s, respectively. CONCLUSIONS: Ring-IT was identified with accuracy and speed by both low vision simulated subjects, and by patients with true limited visual capabilities. These tactile bottle neck ring adaptors can be used as an assistive low vision aid device and may increase eye drop regimen adherence in visually impaired patients.

Bacillus Calmette-Guérin vaccination as defense against SARS-CoV-2 (BADAS): a randomized controlled trial to protect healthcare workers in the USA by enhanced trained immune responses.

BACKGROUND: A large epidemic, such as that observed with SARS-CoV-2, seriously challenges available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in vitro and in vivo. Preliminary analyses suggest that regions of the world with existing BCG vaccination programs have lower incidence and mortality from COVID-19. We hypothesize that BCG vaccination can reduce SARS-CoV-2 infection and disease severity. METHODS: This will be a placebo-controlled adaptive multi-center randomized controlled trial. A total of 1800 individuals considered to be at high risk, including those with comorbidities (hypertension, diabetes, obesity, reactive airway disease, smokers), racial and ethnic minorities, elderly, teachers, police, restaurant wait-staff, delivery personnel, health care workers who are defined as personnel working in a healthcare setting, at a hospital, medical center or clinic (veterinary, dental, ophthalmology), and first responders (paramedics, firefighters, or law enforcement), will be randomly assigned to two treatment groups. The treatment groups will receive intradermal administration of BCG vaccine or placebo (saline) with groups at a 1:1 ratio. Individuals will be tracked for evidence of SARS-CoV-2 infection and severity as well as obtaining whole blood to track immunological markers, and a sub-study will include cognitive function and brain imaging. The majority of individuals will be followed for 6 months, with an option to extend for another 6 months, and the cognitive sub-study duration is 2 years. We will plot Kaplan-Meier curves that will be plotted comparing groups and hazard ratios and p-values reported using Cox proportional hazard models. DISCUSSION: It is expected this trial will allow evaluation of the effects of BCG vaccination at a population level in high-risk healthcare individuals through a mitigated clinical course of SARS-CoV-2 infection and inform policy making during the ongoing epidemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04348370. Registered on April 16, 2020.

Reversing Post-Infectious Epigenetic-Mediated Immune Suppression.

The immune response must balance the pro-inflammatory, cell-mediated cytotoxicity with the anti-inflammatory and wound repair response. Epigenetic mechanisms mediate this balance and limit host immunity from inducing exuberant collateral damage to host tissue after severe and chronic infections. However, following treatment for these infections, including sepsis, pneumonia, hepatitis B, hepatitis C, HIV, tuberculosis (TB) or schistosomiasis, detrimental epigenetic scars persist, and result in long-lasting immune suppression. This is hypothesized to be one of the contributing mechanisms explaining why survivors of infection have increased all-cause mortality and increased rates of unrelated secondary infections. The mechanisms that induce epigenetic-mediated immune suppression have been demonstrated in-vitro and in animal models. Modulation of the AMP-activated protein kinase (AMPK)-mammalian target of rapamycin (mTOR), nuclear factor of activated T cells (NFAT) or nuclear receptor (NR4A) pathways is able to block or reverse the development of detrimental epigenetic scars. Similarly, drugs that directly modify epigenetic enzymes, such as those that inhibit histone deacetylases (HDAC) inhibitors, DNA hypomethylating agents or modifiers of the Nucleosome Remodeling and DNA methylation (NuRD) complex or Polycomb Repressive Complex (PRC) have demonstrated capacity to restore host immunity in the setting of cancer-, LCMV- or murine sepsis-induced epigenetic-mediated immune suppression. A third clinically feasible strategy for reversing detrimental epigenetic scars includes bioengineering approaches to either directly reverse the detrimental epigenetic marks or to modify the epigenetic enzymes or transcription factors that induce detrimental epigenetic scars. Each of these approaches, alone or in combination, have ablated or reversed detrimental epigenetic marks in in-vitro or in animal models; translational studies are now required to evaluate clinical applicability.