Multicenter study on pressure ulcers in hospice patients: prevalence, incidence and associated factors
Project objectivesBackground Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance. Methods This international, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the noninferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week goldstandard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >–10%. The study randomized 808 patients enrolled in 53 centers (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018- 000286-36. Results After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: −0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated. Conclusions Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance. If decompensated, para-inflammation can become inflammation resulting in clinical pathology as seen in various chronic pathologies, including type 2 diabetes and cardiovascular pathologies. At the level of the ocular surface, with aging8, a persistent dysregulation of para-inflammation is established, resulting in the inability of the ocular surface to maintain homeostasis and leading to an asymptomatic inflammatory condition, InflammAgeing. InflammAgeing is a chronic, systemic state of low-grade inflammation and is one of the main risk factors for the development of major age-related diseases10, for example diabetes, atherosclerosis, Alzheimer's disease, COPD and alterations of the ocular surface14,15,17. Despite the positive outcomes in cataract surgery, signs and symptoms of post-operative ocular surface discomfort emerge Many patients who undergo phacoemulsification, the most common procedure performed in ophthalmology units, suffer from dry eye and irritative symptoms postoperatively. Generally, symptoms and signs of dry eye appear 7 days after surgery and their severity increases over time7. In the normal management of patients after cataract surgery, all subjects will be treated with the standard postoperative protocol which consists of the 1st postoperative week with topical chloramphenicol; tapering topical steroids, as per hospital protocol, 4 times a day for 5 days, then 3 times a day for the next 5 days, then 2 times a day for 5 days, and 1 time a day until the 20th day postoperative. Furthermore, any adverse events will be evaluated from the first visit to the last. |
Start and end date |
| September 2018 - January 2019 |
Project Manager |
| Stefano Bonini - Principal Investigator Marco Coassin Antonio Di Zazzo Roberto Sgrulletta |
Coordinating institution of the project |
| PUCBM |
Other Institutions involved |
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Funding source(s). |
• Competitive European grant pharmaceutical company financing
Link to the project websiteClinical Trials register - Search for eudract_number:2019-001660-30 |
