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Purpose: To determine the effectiveness of subconjunctival application of a novel sirolimus liposomal formulation for the treatment of dry eye. Methods: A randomized, triple-blind, Phase II clinical trial. Thirty-eight eyes of 19 patients were included. Nine patients (18 eyes) assigned to the sham group (Sham) and 10 patients (20 eyes) to sirolimus-loaded liposomes group (Sirolimus). The treatment group received three doses of subconjunctival liposome-encapsulated sirolimus and the sham group received three doses of liposomal suspension without sirolimus. Subjective (Ocular Surface Disease Index, OSDI) and measured (corrected distance visual acuity, conjunctival hyperemia, tear osmolarity, Schirmer's test, corneal/conjunctival staining and matrix metalloproteinase-9) variables were measured. Results: Sirolimus-entrapped liposomes-treated group OSDI scores changed from 62.19 (± 6.07) to 37.8 (± 17.81) (p=0.0024), and conjunctival hyperemia from 2.0 (± 0.68) to 0.83 (± 0.61) (p<0.0001); Sham group with OSDI scores from 60.02 (± 14.2) to 36.02 (± 20.70) (p=0.01), and conjunctival hyperemia from 1.33 (± 0.68) to 0.94 (± 0.87) (p=0.048). All the other evaluated outcomes only showed significant differences in the sirolimus group: corneal/conjunctival staining score (p=0.0015), lipid layer interferometry (p=0.006), and inferior meibomian gland dropout (p=0.038). No local or systemic adverse effects regarding the medication itself were reported, and the administration route was well accepted. Conclusion: Our findings suggest that sub-conjunctival sirolimus-loaded liposomes are effective in reducing both signs and symptoms of dry eye in patients with poorly controlled moderate-to-severe DED, while avoiding other topical administration adverse effects. Further investigation with a larger sample size is required to determine long-term effects.
RESUMO
Resumen ANTECEDENTES: En México, la preeclampsia sigue siendo un problema de salud pública; en la actualidad es la principal causa de muerte materna. Su incidencia es de 47.3 casos por cada 1000 nacimientos. La preeclampsia trae consigo repercusiones en la madre y el feto; de ahí la necesidad de la validación de modelos de tamizaje efectivos que permitan su diagnóstico oportuno. La evaluación Doppler de la arteria oftálmica sigue siendo motivo de diversas investigaciones porque aporta información valiosa de los cambios hemodinámicos intracraneales que suceden, incluso, antes del curso sintomático de la enfermedad. OBJETIVO: Analizar las recomendaciones emitidas por diferentes autores que han evaluado la utilización del Doppler de la arteria oftálmica como modelo de tamizaje para la predicción y diagnóstico tempranos de preeclampsia. METODOLOGÍA: Estudio retrospectivo basado en la búsqueda exhaustiva en diferentes bases de datos de metanálisis y estudios clínicos aleatorizados que describieran, detalladamente, la población estudiada y los parámetros de la arteria oftálmica evaluados. RESULTADOS: Se identificaron 22 publicaciones y en el cribado se excluyeron 8 artículos que estaban duplicados, 2 por no cumplir con los criterios de inclusión y 1 por encontrarse en otro idioma diferente al inglés; al final se revisaron 11 títulos y para complementar el tema de estudio se revisaron otros 60 artículos. CONCLUSIONES: La evaluación mediante Doppler de la arteria oftálmica es un examen simple, rápido, reproducible, seguro y no invasivo que puede incorporarse a la predicción y diagnóstico temprano de pacientes con alto riesgo de preeclampsia.
Abstract BACKGROUND: Preeclampsia remains a public health problem in Mexico and is currently the leading cause of maternal death. Its incidence is 47.3 cases per 1000 live births. Pre-eclampsia has consequences for the mother and the fetus, so there is a need to validate effective screening models for early diagnosis. Doppler assessment of the ophthalmic artery continues to be studied because it provides valuable information on intracranial hemodynamic changes that occur before the symptomatic course of the disease. OBJECTIVE: To analyze the recommendations of different authors who have evaluated the use of ophthalmic artery Doppler as a screening model in the prediction and early diagnosis of pre-eclampsia. METHODOLOGY: Retrospective study based on the search exhaustive search of different databases of meta-analyses and randomized clinical trials describing in detail the population studied and the ophthalmic artery parameters evaluated. RESULTS: Twenty-two publications were identified and after screening, 8 articles were excluded as duplicates, 2 for not meeting the inclusion criteria and 1 for being in a language other than English; finally, 11 titles were reviewed, and another 60 articles were reviewed to complement the study topic. CONCLUSIONS: Doppler evaluation of the ophthalmic artery is a simple, rapid, reproducible, safe, and noninvasive test that can be used to evaluate the ophthalmic artery.