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BACKGROUND: The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin® SF), for management of postoperative inflammation and pain, after cataract surgery. METHODS: This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intent-to-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE). RESULTS: A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively). CONCLUSION: The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.
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BACKGROUND: Dry eye disease (DED) is a chronic, multifactorial disease of the ocular surface leading to discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. AIM: The aim of this study was to assess the clinical benefit of a switch from preserved to preservative-free artificial tears (ATs) containing hyaluronate in patients with DED. MATERIALS AND METHODS: This is a nationwide, multicenter, noninterventional, and transversal observational survey. RESULTS: The mean age was 51.0±15.4 years, ranging from 6 to 96 years. The majority (61.4%) was female. The mean Ocular Surface Disease Index (OSDI) before the switch was surprisingly high at 56.0±23.5, and 73.0% of the patients had superficial punctate keratitis (SPK). The mean duration of use of preserved ATs before the switch was 15.8±12.1 months. OSDI scores and the presence of SPK correlated with the patients' ages but were independent of the duration of treatment with the preserved AT. The patients using ATs containing "soft" or "vanishing" preservatives presented exactly the same clinical pattern (level of OSDI and frequency of SPK) as those using ATs containing classical preservatives such as benzalkonium chloride (BAK). After switching to preservative-free AT containing hyaluronate (Hyabak®), the OSDI of 97.0% of the patients improved, decreasing from an average of 56.0 to an average of 28.2, with 23% of patients reporting a normal value of OSDI. The SPK frequency as well improved dramatically, with a frequency of positive fluorescein staining dropping from 73% to 46.1% of patients. A total of 94.0% of the patients considered that they preferred being treated with the preservative-free AT. CONCLUSION: In patients suffering from DED and treated with a preserved AT, switching to a preservative-free AT provides clinical benefit by decreasing the severity of DED and reducing the prevalence of SPK, even after only 3 weeks of daily use of the preservative-free AT.
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Objetivo: Reportar un caso con el síndrome de contracción capsular. Métodos: Descripción de la exploración oftalmógica y de los diferentes procedimientos quirúrgicos realizados. Resultados: Caso clínico de un paciente masculino de 53 años de edad, postoperado de catarata congénita con técnica de facoemulsificación con implante de lente intraocular de silicona, que a los 2 años de operado desarrolló un síndrome de contracción capsular, bajando su capacidad visual de 20/50 a cuenta dedos a 5 pies, requiriendo una nueva intervención quirúrgica consistente en capsulotomía anterior quirúrgica, bajo anestesia local, y posteriormente una capsulotomía posterior con láser de Nd: Yag, recuperando una capacidad visual de 20/80. Conclusiones: Se recomienda no realizar capsulorrexis pequeña; ésta debe ser del tamaño del óptico del lente intraocular a utilizarse, sobre todo en aquellos pacientes de alto riesgo en el desarrollo de esta patología.
Assuntos
Humanos , Masculino , Pessoa de Meia-Idade , Capsulorrexe , Cápsula do Cristalino/cirurgia , Facoemulsificação , Extração de Catarata/efeitos adversosRESUMO
El síndrome de Weill-Marchesani es un trastorno raro de herencia recesiva, caracterizado por talla corta, dedos rollizos y cortos y, en ocasiones, retraso mental. Entre las manifestaciones oculares la más importante es la microesferofaquia que, durante la adolescencia o al principio de la segunda década de la vida, puede cursar con una dislocación del cristalino hacia abajo. En ocasiones este síndrome se puede asociar a anomalías del ángulo camerular por disgenesias mesodérmicas y a glaucoma por bloqueo pupilar. El tratamiento en este síndrome dependerá de cada caso.