Purpose To evaluate the safety and efficacy of a novel medical device to provide cooling anesthesia to the eye as local anesthesia for intravitreal injections. Study Design First in human, open-label study of 43 subjects assessed at three different doses: −10°C for 20 seconds (group 1), −15°C for 15 seconds (group 2), and −15°C for 20 seconds (group 3). Main outcome measures were safety and pain of injection using a numeric rating scale (NRS). Results Cooling anesthesia did not result in any serious ocular adverse events. One grade 1 adverse event was a vasovagal response during cooling administration which resolved immediately after cooling. Mean NRS scores at the time of injection for each group ranged from 2.5 to 4.3 There was a statistically significant difference between pain scores of the 3 groups at injection in aggregate but not in pairwise comparisons ( P value = 0.047). There was a statistically significant decrease in pain from injection to 5 minutes post injection in all groups ( P value = 0.00008, 0.003, 0.0005 for groups 1, 2, 3, respectively) as well as from 5 minutes to 24–48 hours ( P value = 0.00001, 0.018, and 0.0545 for groups 1, 2, 3, respectively). Conclusion The rapid cooling anesthesia device was well tolerated for achieving local anesthesia among patients receiving intravitreal injections with no serious ocular adverse events.

Background and aim The current paradigm of measuring esophageal contractile vigor assesses the entirety of a pressure wave using a single measurement, the distal contractile integral (DCI). We hypothesize that an assessment identifying separate phases of the contractile pressure wave before and after the pressure peak may help distinguish abnormalities in patients presenting with chest pain and dysphagia. The aim of the present study was to develop a technique to assess the individual phases and report on the values in healthy controls. Method 71 Healthy controls were enrolled. High resolution manometry studies of five intact liquid swallows in both supine and upright positions were analyzed using a customized MATLAB program to divide swallows into a pre-peak phase and post-peak phase, and compute the contractile integral of both phases. The contractile integrals were also controlled by duration over each phase. Result The composite DCI measurement in healthy controls appears to be weighted towards slightly higher contractile activity during post-peak phase based on post-peak to pre-peak ratios in both the supine and upright position (1.50 and 1.49 respectively). The contribution of post-peak phase on the composite DCI was weakened when controlled by time (0.92 and 0.96 in both supine and upright position respectively). Conclusion We developed a novel measurement focused on separating the pre-peak and post-peak components of the peristaltic contractile activity during swallowing. Using this technique, it appears that overall contractile activity is higher during post-peak phase and this is related to the longer time component during this phase.

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