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The aim of this study is to report the clinical outcomes of oral supplementation with curcumin-phospholipid in addition to hyaluronic acid-based tear substitute for the management of dry eye disease (DED). Patients with a diagnosis of DED confirmed by pathological values of both NIKBUT 12 were included. Patients were randomized to receive 2 different treatments: 0.25% hyaluronic acid-based tear substitute 3 time daily (Group 1) or as above plus curcumin-phosphatidylcholine complex tablets once a day (Group 2). Patients were evaluated at baseline (T0) and after 90 days of treatment (T1) by means of Keratograph for the measurement of NIKBUT, TMH, meibomian gland dropout and bulbar redness. Overall, data from 90 eyes of 45 patients were included. Group 1 consisted of 48 eyes of 24 patients, while group 2 included 42 eyes of 21 patients. When comparing median values of both groups at T0, no statistically significant differences were found for all parameters; instead for T1, statistically significant differences were found for redness and OSDI compared to Group 1. In group 1, a statistically significant reduction after the treatment was detected for Nikbut average and OSDI questionnaire; while in group 2, a statistically significant reduction after treatment was recorded for Nikbut average, bulbar redness and OSDI questionnaire. The addition of an oral supplement containing curcumin-phospholipid may help in a greater improvement of bulbar redness and subjective ocular symptoms compared to the treatment with tear substitutes alone for the management of DED.

BackgroundFasting is usually recommended in patients undergoing cataract surgery under topical anesthesia. However, starving before surgery may increase preoperative anxiety and affect surgical outcomes. It is not known which fasting or non-fasting strategy is best for cataract surgery. The aim of this study was to compare non-fasting and fasting strategy in patients undergoing cataract surgery under topical anesthesia with regard to surgical outcomes, anxiety and pain.MethodsThis randomized, crossover, controlled trial enrolled patients undergoing surgery for bilateral cataract under topical anesthesia at Cochin Hospital (Paris, France), from February to May 2021. Patients were randomly assigned to the non-fasting or fasting group for the first eye surgery and were switched to the other group for the second eye surgery. The primary endpoint was to compare the rate of anesthetist's interventions during surgery. The secondary endpoints included intra-operative complications, duration of surgery, surgeon perception of surgical difficulty, anesthesia-related complications and anxiety and pain level.Resultsone hundred and nine consecutive patients were included, with 60 of them being fasted first and non-fasted for the second eye surgery, while the other 59 were non-fasted first and fasted for the next surgery. The number of patients requiring sedation was significantly lower in the non-fasting group compared with the fasting group [1%; 95%IC (0-3.2) vs. 6%; 95%IC (2.9-8.9), P = 0.04]. No anesthesia-related complications were observed. There was no difference in the number of intra-operative complications between the non-fasting and the fasting groups (,respectively, 0 and 1; P = 1). Anxiety level and surgical pain were significantly lower in the non-fasting group compared to the fasting group (,respectively, 2.3 ± 2.0 vs. 4.1 ± 2.4, P = 0.01 and 0.6 ± 0.6 vs. 2.6 ± 3.4, P = 0.003). The mean duration of surgery was significantly shorter in the non-fasting group compared with the fasting group (,respectively, 16.0 ± 5.9 vs. 22.3 ± 6.1 min; P = 0.03).ConclusionIn conclusion pre-operatory non-fasting strategy provides a better patient experience with regards to preoperative anxiety and surgical pain. It allows to reduce operating times and is safe and well-tolerated as regards the anesthetic intervention.

Purpose: This study evaluates if the addition of a curcumin formulation with a polyvinylpyrrolidone-hydrophilic carrier (CHC; Diabec®, Alfa Intes, Italy) to intravitreal injections of dexamethasone (DEX-IVT) can affect the morphological retinal characteristics, extending the steroid re-treatment period in patients with diabetic macular edema (DME).Methods: A randomized controlled clinical trial was carried out in DME patients, randomly assigned to receive DEX-IVT or DEX-IVT and a CHC. The evaluation of the mean difference of central retinal thickness (CRT) was the primary aim. Secondary aims were the evaluations of best-corrected visual acuity, differences in the predetermined retinal layer thickness, the number/time of re-treatment, and the assessment of safety.Results: A total of 73 DME patients were included (35 in the control group and 38 in the combined therapy group). In both the control and combined therapy groups, the mean CRT change from T0 to the 6 months’ evaluation was significant (p = 0.00). The mean CRT result was significantly different at month 4 (p = 0.01) between the control and combined therapy groups, with a greater reduction in the combined therapy group, in particular, in patients with ≤10 years of diabetes. A trend of CRT reduction in the combined therapy group has been observed also considering patients with subfoveal neuroretinal detachment. In addition, we observed that the reduction of inner retinal layer thickness was greater in the combination group, in comparison with controls.Conclusion: The combination of a CHC to DEX-IVT is a promising therapeutic option in case of DME, in particular, for patients with early-stage diabetes and with an inflammatory phenotype. Further studies will be necessary to confirm these findings.

The aim of the present study was to investigate the impact of preoperative music exposure on intra- and post-operative pain during cataract surgery. This study was conducted alongside a prospective single-masked randomized controlled trial (ClinicalTrials.gov NCT02892825). Patients undergoing first eye cataract surgery were included and randomly assigned to either the intervention or control group. Patients in the intervention group had a 20-min music session through earphones before surgery, while patients in the control group wore earphones without music. Anxiety level evaluated using the visual analog scale and heart rate were collected before and after music intervention. Pain level was assessed using the Numerical Pain Rating Scale, during the surgical procedure, prior to discharge and 7 days postoperatively. A total of 243 patients were included: 119 in the intervention group and 124 in the control group. No significant differences in baseline characteristics, including age, sex and rate of treated hypertension were found between the 2 groups (all p-values > 0.05). In addition, no significantly differences were found in heart rate and anxiety level before music intervention between the 2 groups (all p-values > 0.05). Conversely, anxiety level was significantly lower in the music group after the intervention (respectively, 1.3 ± 1.1 vs 3.2 ± 2.2; p < 0.05). Patients in the music group reported a lower mean pain level during surgical procedure and before discharge compared with control group (respectively, 1.2 ± 0.5 vs 2.1 ± 1.1, p = 0.03 and 0.23 ± 0.4 vs 0.81 ± 0.7, p = 0.04). No difference was found in pain level 7 days postoperatively (0.1 ± 0.3 vs 0.2 ± 0.4, p = 0.1). A significant correlation was found between anxiety level and intraoperative pain level (R = 0.64, p = 0.02). In conclusion, music intervention was effective in reducing anxiety level and self-reported pain both during surgery and in the early postoperative period.Clinical Trial Registration:https://clinicaltrials.gov/ct2/home, identifier NCT02892825.