ABSTRACT
PURPOSE: To determine the effect of short-term 4 mg/mL dexamethasone solution treatment in diabetic macular edema (DME). PATIENTS AND METHODS: Twenty-seven pseudophakic diabetic patients with visual impairment caused by DME were randomized to receive 0.01 mL (40 µg), 0.03 mL (120 µg) or 0.05 mL (200 µg) intravitreal dexamethasone solution. Eyes were evaluated in terms of macular thickness, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at 3, 7 and 28 days after injection (D). RESULTS: There was a significant reduction in macular thickness between D0 and D3 for all groups (0.01 mL - P=0.008, 0.03 mL - P=0.038, and 0.05 mL - P=0.008). Between D0 and D7, a significant reduction in macular thickness was observed in 0.01 mL and 0.05 mL groups (0.01 mL - P=0.013 and 0.05 mL - P=0.021). Between D0 and D28, no significant reduction of macular thickness was observed for any group. Between D0 and D3, a significant improvement in BCVA in the 0.03 mL group (P=0.028) was observed. Between D0 and D7, a significant improvement in BCVA was observed in 0.01 mL and 0.03 mL groups (0.01 mL - P=0.018 and 0.03 mL - P=0.027). Between D0 and D28, a significant improvement in BCVA was observed for the 0.01 mL group (P=0.017). No significant differences in IOP measurements were observed for any group. Safety analysis revealed no serious ocular or systemic events. CONCLUSION AND RELEVANCE: Intravitreal dexamethasone solution is effective in reducing macular thickness secondary to DME in the short-term. Improvement in short-term visual acuity was observed. Although DME requires long-term treatment, it may be a low cost therapeutic option used in specific short-term situations.Trial registration: NCT03608839 (http://www.clinicaltrials.gov).
ABSTRACT
Objetivos. El objetivo de este estudio consistió en determinar si la realización rutinaria de pruebas clínicas antes de la cirugía de cataratas reduce la tasa de complicaciones perioperatorias en adultos. Métodos. El estudio se realizó en un centro médico universitario de Brasil entre el 10 de febrero de 2000 y el 10 de enero de 2001. Los pacientes con operaciones de cataratas programadas fueron asignados aleatoriamente a un grupo en el que las pruebas preoperatorias se realizaron de forma rutinaria (grupo R) o a un grupo en el que se realizaron de forma selectiva (grupo S). A los pacientes asignados al grupo S solo se les solicitaron pruebas preoperatorias en caso de que presentaran un problema médico nuevo o agravado que justificara su realización. En el grupo R se practicaron tres pruebas preoperatorias de forma rutinaria: un electrocardiograma de 12 derivaciones, un hemograma completo y una determinación de la glucemia. Resultados. De los 1 025 pacientes estudiados, 512 fueron asignados al grupo R y 513 al grupo S. La proporción de intervenciones canceladas y no programadas nuevamente fue similar en ambos grupos: 2% en cada uno. La tasa acumulada de complicaciones médicas también fue similar en ambos grupos: 9,6% en el grupo R y 9,7% en el S (P = 0,923). Lo mismo ocurrió con los tipos de complicaciones médicas observadas. Conclusiones. Los resultados de este estudio indican que la realización rutinaria de pruebas médicas antes de la cirugía de cataratas no reduce la tasa de complicaciones perioperatorias y que parece ser más eficiente no solicitar pruebas preoperatorias, a no ser que la historia clínica o la exploración física del paciente indiquen su realización
Objective. The objective of this study was to investigate whether routine medical testing before cataract surgery reduces the rate of complications during the perioperative period in adults. Methods. The study was carried out in an academic medical center in Brazil, between 10 February 2000 and 10 January 2001. The scheduled cataract operations were randomly assigned to one of two groups: 1) to be preceded by routine testing (the "routine-testing group") or 2) not to be preceded by routine medical testing (the "selective-testing group"). If the patient was assigned to the selective-testing group, it was requested that no preoperative testing be performed unless the patient presented with a new or worsening medical problem that would warrant medical evaluation with testing. In the case of patients assigned to the routinetesting group, three tests were requested: a 12-lead electrocardiogram, a complete blood count, and measurements of serum glucose. Results. The sample of 1 025 patients scheduled to undergo cataract surgery was comprised of 512 assigned to the routine-testing group and of 513 assigned to the selective-testing group. The two groups had similar proportions of operations canceled and not subsequently rescheduled, 2% in each group. The cumulative rate of medical events was similar in the two groups, 9.6% in the routine-testing group and 9.7% in the selective-testing group (P = 0.923). The types of medical events were also similar in both groups. Discussion. The results of this study suggest that routine medical testing before cataract surgery does not reduce the rate of complications during the perioperative period. The results also suggest it would be more efficient not to request routine preoperative tests unless indicated by patient history or physical examination
