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Purpose: To compare the performance of nylon sutures to that of polyglactin sutures in pediatric patients undergoing cataract surgery. Setting: University of Campinas (UNICAMP), Campinas, São Paulo, Brazil Design: A prospective, randomized, partially masked, single-site clinical trial. (https://clinicaltrials.gov/ct2/show/NCT03812640). Methods: A total of 80 eyes from 80 patients who underwent pediatric cataract surgery were randomized into two groups in block sizes of four. Group A consisted of 41 patients whose surgical incisions were sutured with polyglactin 10-0 material. Group B consisted of 39 patients whose surgical incisions were sutured with nylon 10-0 material. The primary outcome was frequency of suture-related complications in each group. Secondary outcomes were the frequency with which suture removal was necessary. Results: The incidence of suture-related complications within 6 months of follow up was 0 out of 41 eyes (0.00%) in the polyglactin group and 17 out of 39 eyes (43.59%) in the nylon control group (p < 0.001). In all of the eyes with suture-related complications, the sutures were promptly removed. The most frequent complications were vascularization near the suture (17.95%) and loose sutures (17.95%). No ocular or systemic study-related adverse events were observed. Conclusions: Polyglactin sutures were found to be safe and effective for pediatric patients undergoing cataract surgery. Their lower rate of complications and reduced likelihood of removal (and the subsequent need for general anesthesia) make their use preferrable to that of nylon sutures. This study represents the first controlled randomized clinical trial to compare nylon sutures to polyglactin sutures in pediatric patients undergoing cataract surgery. Clinical Trial Registration: URL: https://clinicaltrials.gov/ct2/show/, Identifier: NCT03812640.
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PURPOSE: To evaluate outcomes of resident-performed cataract surgeries in different training levels in a retrospective case series. PATIENTS AND METHODS: A total of 730 surgeries performed by residents were evaluated into three groups: surgeries performed during residents' first semester of training in phacoemulsification (Level 1 - L1), surgeries performed during the second semester (Level 2 - L2), and surgeries performed during the third semester (Level 3 - L3). The primary outcome was the incidence of intraoperative complications in each group. Secondary outcomes were the comparisons between initial and final corrected distance visual acuity (CDVA), intraocular pressure (IOP), endothelial cell density (ECD), and central corneal thickness (CCT) in each group. Descriptive statistical analyses were employed in the presentation of the results using central tendency and variance measurements. RESULTS: The rate of complications within six weeks of follow-up was 24 out of 102 eyes (23.53%) in the L1 group, 63 out of 301 eyes (20.93%) in the L2 group, and 37 out of 327 (11.31%) in the L3 group (p=0.001). Posterior capsule rupture (PCR) was the most frequent intercurrence observed in all three semesters: it occurred in 12.7% of the surgeries in the first semester (13/102), 16.9% of surgeries in the second semester (51/301), and 9.5% of surgeries in the third semester (31/327). There was no significant difference in CDVA (p=0.298), ECD (p=0.067), IOP (p=0.217), or CCT (p=0.807) between the groups. CONCLUSION: When measured by rates of complications and by the aforementioned parameters, surgical competency was found to improve as surgical experience and frequency increased. Therefore, this study identified some patterns of skill development that can be applied to teaching strategies and better assist surgeons in training.
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PURPOSE: To evaluate the safety and efficacy of intracameral (IC) 0.5% moxifloxacin in the prevention of post-cataract endophthalmitis. SETTING: University of Campinas, São Paulo, Brazil. DESIGN: Prospective randomized partially masked single-site clinical trial. METHODS: Patients who had phacoemulsification were randomized into two groups in block sizes of 4. Group A (moxifloxacin group) consisted of patients who received an IC injection of 0.03 mL (150 µg) of undiluted 0.5% moxifloxacin at the end of surgery. Group B (control group) consisted of patients who received no IC medication. The postoperative prescription for both groups consisted of 0.5% moxifloxacin and 0.1% dexamethasone. Patients were monitored for 6 weeks after surgery. The primary outcome was the incidence of acute endophthalmitis in each group. Secondary outcomes were corrected distance visual acuity (CDVA), endothelial cell density (ECD), intraocular pressure (IOP), and central corneal thickness (CCT). RESULTS: The study comprised 3640 eyes from 3640 patients. There were 1818 patients in Group A and 1822 patients in Group B. The incidence of endophthalmitis within 6 weeks of follow-up was 1 (0.05%) of 1818 eyes in the moxifloxacin group and 7 (0.38%) of 1822 eyes in the control group (P = .035). There was no significant difference in CDVA (P = .202), ECD (P = .482), IOP (P = .105), or CCT (P = .558). No ocular or systemic study-related adverse events were observed. CONCLUSIONS: The IC injection of undiluted 0.5% moxifloxacin can be safely applied as the last step of phacoemulsification. It was found to be effective in reducing the risk for endophthalmitis. This study represents the first controlled randomized clinical trial to evaluate the safety and efficacy of IC moxifloxacin in the prevention of post-cataract endophthalmitis.
