RESUMEN
Aim: To compare pupil dilation achieved by a single microdose versus two microdoses of tropicamide-phenylephrine fixed combination (TR-PH FC) delivered by the Optejet®. Patients & methods: In this assessor-masked, crossover, noninferiority study, 60 volunteers underwent two treatment visits and received either one (â¼8 µl) or two sprays (â¼16 µl) of TR-PH FC to both eyes in randomly assigned order. Results: At 35 min postdose, mean change in pupil diameter was 4.6 mm and 4.9 mm following one or two sprays, respectively. The estimated treatment group difference was -0.249 mm (standard error: 0.036; 95% CI: -0.320, -0.177). No adverse events were reported. Conclusion: A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. Clinical Trial Registration: NCT04907474 (ClinicalTrials.gov).
Pupil dilation efficacy and efficiency were evaluated using microdosing via the Optejet®. The Optejet® is a new ophthalmologic drug device that utilizes piezoelectric technology to deliver a fine, controlled, horizontal microdroplet spray with precise volume (â¼8 µl), spray pattern and velocity. A single spray versus two sprays of tropicamide-phenylephrine fixed combination (TR-PH FC) were administered to both eyes anesthetic free. Efficacy and safety were evaluated at specific time intervals. The primary end point was the mean change in pupil diameter at 35 min compared with baseline. At 35 min, clinically relevant dilation was observed, with a mean change of 4.55 mm ± 0.68 for one spray and 4.88 ± 0.60 for two sprays. The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p < 0.001). Rapid dilation was observed at 15 min, and the proportions of eyes that achieved a pupil diameter of ≥6.0 mm were 74% and 83% of patients at 15 min with one spray and two sprays, respectively. The mydriatic agent was well tolerated with the delivery system even in the absence of topical anesthetic, with no ocular or system adverse events reported. Mydriasis is a vital component of routine eye healthcare, and the current standard-of-care mydriatic eye drops potentially have limitations, including contamination, spillage and burning/stinging. Delivery of a mydriatic with the Optejet® may improve patient care flow in the clinical office setting.
Asunto(s)
Midriáticos , Pupila , Humanos , Soluciones Oftálmicas , Tropicamida , FenilefrinaRESUMEN
The commercial exploitation of guinea fowl (Numidia meleagris) is a viable alternative for small rural properties in arid and semi-arid regions, as they are rustic birds and capable of withstanding the climatic adversities of these regions. The objective of this study was to evaluate the pupillary temperature, smaller pupillary diameter, larger pupillary diameter and pupil area of guinea fowl housed in a controlled environment, under two air temperatures: 26 ºC (thermal comfort zone) and 32 ºC (above the thermal comfort zone). The birds were distributed in a completely randomized design, with two treatments (air temperatures) and four replications (experimental box), with twelve birds each. The increase in air temperature resulted in a significant average increase (P < 0.05) of 6.0, 17.9, 18.6 and 38.4%, respectively, in pupillary temperature, smaller pupillary diameter, larger pupillary diameter and pupillary area of birds, being these measurements accurate in evaluation of thermal stress in homeothermic animals.
Asunto(s)
Animales , Pollos/fisiología , Trastornos de Estrés por Calor/diagnóstico , Trastornos de Estrés por Calor/veterinaria , Ambiente ControladoRESUMEN
The commercial exploitation of guinea fowl (Numidia meleagris) is a viable alternative for small rural properties in arid and semi-arid regions, as they are rustic birds and capable of withstanding the climatic adversities of these regions. The objective of this study was to evaluate the pupillary temperature, smaller pupillary diameter, larger pupillary diameter and pupil area of guinea fowl housed in a controlled environment, under two air temperatures: 26 ºC (thermal comfort zone) and 32 ºC (above the thermal comfort zone). The birds were distributed in a completely randomized design, with two treatments (air temperatures) and four replications (experimental box), with twelve birds each. The increase in air temperature resulted in a significant average increase (P < 0.05) of 6.0, 17.9, 18.6 and 38.4%, respectively, in pupillary temperature, smaller pupillary diameter, larger pupillary diameter and pupillary area of birds, being these measurements accurate in evaluation of thermal stress in homeothermic animals.(AU)