Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin.

The aim of this work was to assess the tolerability, safety, and efficacy of an ophthalmic topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% (HA) in patients with mild-to-moderate Dry Eye Disease (DED) exhibiting positive Matrix Metalloproteinase 9 (MMP-9) test results. Tolerability and safety were evaluated in 24 healthy subjects. Participants were instructed to apply one drop of the formulation three times a day in the study eye, for 2 weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/receiving the studied formulation) or Control (Group 2/Receiving HA 0.4% eye lubricant) groups for 1 month. Assessments included an MMP-9 positivity test, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive film tear breakup time (NIBUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer's test, and meibomiography. A crossover design with an additional 1-month follow-up was applied to both groups. Healthy subjects receiving the studied formulation exhibited good tolerability and no adverse events. Regarding the efficacy study, Group 1 exhibited a statistically significant reduction in the MMP-9 positivity rate compared to Group 2 (p < 0.001). Both Group 1 and Group 2 exhibited substantial improvements in OSDI and NIBUT scores (p < 0.001). However, Group 1 demonstrated a significant improvement in NI-Avg-BUT and Schirmer's test scores (p < 0.001), whereas Group 2 did not (p > 0.05). Finally, after the crossover, the proportion of MMP-9-positive subjects in Group 1 increased from 25% to 91.6%, while Group 2 showed a significant decrease from 87.5% to 20.8%. Overall, the topical formulation containing sesquiterpene helenalin from Arnica montana and hyaluronic acid was well tolerated and exhibited a favorable safety profile. Our formulation reduces DED symptomatology and modulates the ocular surface inflammatory process; this is evidenced by the enhancement of CIC, the improvement of DED-related tear film status, and the reduction of the MMP-9 positivity rate.

An Oral Polyphenol Formulation to Modulate the Ocular Surface Inflammatory Process and to Improve the Symptomatology Associated with Dry Eye Disease.

Due to their antioxidant, anti-inflammatory, neuroprotective, and anti-angiogenic effects, polyphenols are first-rate candidates to prevent or treat chronic diseases in which oxidative stress-induced inflammation plays a role in disease pathogenesis. Dry eye disease (DED) is a common pathology, on which novel phenolic compound formulations have been tested as an adjuvant therapeutic approach. However, polyphenols are characterized by limited stability and solubility, insolubility in water, very rapid metabolism, and a very short half-life. Thus, they show poor bioavailability. To overcome these limitations and improve their stability and bioavailability, we evaluated the safety and efficacy of an oral formulation containing among other compounds, polyphenols and omega-3 fatty acids, with the addition of a surfactant in patients with DED. Subjects were randomly assigned to one of four study groups including the study formulation (A), placebo (P), the study formulation + eye lubricant (A + L), and placebo + eye lubricant (P + L). Patients from the A and P groups were instructed to take two capsules every 24 h, while patients in the L groups also added one drop of lubricant twice a day for 12 weeks as well. Regarding safety, non-ocular abnormalities were observed during study formulation therapy. Liver function tests did not show any statistically significant difference (baseline vs. week 4). Concerning efficacy, there was a statistically significant difference between baseline, month 1, and month 3 in the OSDI (Ocular Surface Disease Index) test results in both treatment groups (group A and group A + L). Furthermore, both groups showed statistically significant differences between baseline and month 3 regarding the non-invasive film tear breakup time (NIF-BUT) score and a positive trend related to Shirmer's test at month 3. The non-invasive average breakup time (NIAvg-BUT) score showed a statistically significant difference at month 3 when compared with baseline in the A + L group. The P + L group showed a statistically significant difference in terms of the OSDI questionary between baseline and month 3. Regarding the lissamine green staining, the A + L group showed a statistical difference between baseline and month 3 (p = 0.0367). The placebo + lubricant group did not show statistically significant differences. Finally, the placebo group did not show any data with statistically significant differences. Consequently, this polyphenol formulation as a primary treatment outperformed the placebo alone, and the polyphenol oral formulation used as an adjuvant to artificial tears was superior to the combination of the placebo and the artificial tears. Thus, our data strongly suggest that this polyphenol oral formulation improves visual strain symptoms and tear film status in patients with mild to moderate DED.

Topical Triamcinolone Acetonide-Loaded Liposome Formulation Used as an Adjuvant to Intravitreal Ranibizumab Therapy for Neovascular Age-Related Macular Degeneration.

Novel strategies have been developed to reduce or avoid intravitreal injections (IVTs) of the antiangiogenic (ranibizumab (RBZ)) and anti-inflammatory (triamcinolone acetonide (TA)) agents used to treat vitreoretinal diseases. One of the strategies includes liposomes. This study evaluated the safety and efficacy of a topical triamcinolone-loaded liposome formulation (TALF) as an adjuvant to intravitreal RBZ therapy in treatment- naïve patients with neovascular age-related macular degeneration (nAMD). Subjects were randomly assigned to the RBZ-TALF or the RBZ-pro re nata (RBZ-PRN) groups. Patients from the RBZ-TALF group were instructed to apply TALF for 12 months after a single dose of RBZ. Patients from the RBZ-PRN group received three monthly RBZ-IVTs. Retreatment with RBZ was considered in the case of nAMD reactivation. Regarding safety, non-ocular abnormalities were observed during TALF therapy. Concerning efficacy, non-significant differences were identified in terms of visual acuity or central foveal thickness when the RBZ-PRN and RBZ-TALF groups were compared. It is worth noting that the average number of RBZ injections was significantly lower in the RBZ-TALF group (2.5 ± 1.4 vs. 6.1 ± 1.3 IVTs; p = 0.0004). Therefore, TALF used as an adjuvant to RBZ reduces the need for RBZ-IVT retreatment with optimal visual and anatomic results.

Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema.

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards.

Topical Triamcinolone Acetonide-Loaded Liposomes as Primary Therapy for Macular Edema Secondary to Branch Retinal Vein Occlusion: A Pilot Study.

Purpose: To explore safety and therapeutic efficacy of a topical ophthalmic triamcinolone acetonide-loaded liposome formulation (TA-LF) as primary therapy in patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Methods: Twelve eyes of 12 patients with ME secondary to BRVO were exposed to a topical instillation of 1 drop of TA-LF (TA 0.2%) 6 times a day for 12 weeks to evaluate safety and efficacy. Best corrected visual acuity (BCVA) intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit. In addition, the morphology of TA-LF was analyzed using scanning electron microscopy (SEM) and transmission electron microscopy (TEM). Results: Patients presented a significant improvement of BCVA and CFT without significant IOP modification (P = 0.94). Treated eyes showed BCVA improvement from 40 ± 12.05 to 64.83 ± 15.97 letters and CFT reduction from 682.91 ± 278.60 to 271.58 ± 57.66 µm after 12 weeks of TA-LF therapy (P < 0.001). No adverse events, including IOP rising, were registered. SEM analysis of liposomal formulations showed that liposome (LP) size depends on its concentration. As the concentration of TA increased, the average size of LPs and the number of larger particles increased as well. TEM study displayed that LP formulation efficiently solubilizes TA crystals in nanoparticles and encapsulates them. Conclusion: LPs can function as nanocarriers of TA and they could be used as topical ophthalmic primary therapy instead of intravitreal drugs in patients with ME secondary to BRVO.

Novel Triamcinolone Acetonide-Loaded Liposomal Topical Formulation Improves Contrast Sensitivity Outcome After Femtosecond Laser-Assisted Cataract Surgery.

Purpose: To assess visual results, macular modifications, and the incidence of clinically significant macular edema (CSME) in patients using a topical triamcinolone acetonide-loaded liposomal formulation (TA-LF) after femtosecond laser-assisted cataract surgery (FLACS). Methods: Fifty-six eyes after FLACS were selected. Twenty-eight eyes in the combined therapy group (P + N) were treated with prednisolone 1% and nepafenac 0.1% for 21 days postoperatively, whereas 28 eyes in the TA-LF group received a liposomal formulation containing 2 mg/mL of TA (0.2%) for the same period of time. Follow-up visits at 1 day, 6 weeks, and 12 weeks after surgery consisted of visual acuity, contrast sensitivity (CS), central foveal thickness (CFT), total macular volume (TMV) measurements, and the detection of CSME. Results: CS improved in the TA-LF group (basal value: 1.087 ± 0.339 vs. 1.276 ± 0.147 at week 12, P = 0.0346), whereas in the P + N group, CS was not different from the baseline (basal value: 1.130 ± 0.331 vs. 1.274 ± 0.133 at week 12, P = 0.1276). There were similar increases in postoperative CFT and TMV in both groups. CFT and TMV significantly correlate with CS only in the TA-LF group. The r2 for CFT and CS was 0.1963 (P = 0.0206), whereas the r2 for TMV and CS was 0.3615 (P = 0.0007) at 12 weeks. No difference was observed in the incidence of CSME between the groups. Conclusion: TA-LF is associated with better CS outcomes compared to combined therapy after FLACS.

Inicio del programa de implantes cocleares en el Hospital Vozandes quito / Launching the program cochlear implant at the Hospital Vozandes Quito

El advenimiento de nuevas tecnologías ha llevado al equipo médico a un trabajo multidisciplinario coordinado, así como al adiestramiento en nuevas técnicas quirúrgicas. Pacientes niños y adultos se han visto beneficiados de opciones terapéuticas impensables hasta hace poco, siendo los criterios de selección cuidadosos los que han permitido un inicio exitoso del programa de implantes cocleares en el Hospital Vozandes Quito. Por medio de la presente revisión de casos se reporta nuestra experiencia en el inicio de del programa de implantes cocleares.

Rinosinusitis Fúngica, relato de un caso y revisión de la literatura / Fungal rhinosinusitis, case report and literature review

La rinosinusitis fúngica es una entidad poco sospechosa. Se le ha clasificado en invasiva y no invasiva; cada una, con distinto criterio diagnóstico, tratamiento y pronóstico. Presentamos el caso clínico de una paciente femenina de 27 años que consulta por presentar rinosinusitis crónica refractaria a tratamientos repetidos. La TC SPN inicial revela velamiento integral del seno maxilar derecho con una imagen de mayor densidad radiológica en su interior, velamiento parcial de etmoides anterior, posterior y esfenoidal del mismo lado. Se inicio tratamiento clínico con antibioticoterápia descongestionantes nasales e irrigación nasal con lo que la paciente tuvo alivio sintomático parcial. Luego de dos meses y medio la TC SPN de control demuestra solo mejoría del seno esfenoidal, entonces, la paciente fue sometida a cirugía endoscópica nasal encontrando una mas amarillo - marrón en seno maxilar que fue extraida. El cultivo no reportó crecimiento de hongos. El diagnóstico final fue de un micetoma o bola fúngica en seno maxilar derecho más conchas medias bulosas. la paciente evolucionó sin complicaciones. Concluimos que el micetoma así como los otros tipos de RSF son entidades no tan raras como se cree y debe ser siempre considerada dentro de los diagnósticos diferenciales de todo proceso de RSC.

Fungal rhinosinusitis is a little suspicious entity. It has been classified as invasive and non-invasive; each, with different diagnostic criteria, treatment and prognosis. We present the clinical case of a 27-year-old female patient who consults for presenting chronic rhinosinusitis refractory to repeated treatments. The initial SPN CT reveals complete veiling of the right maxillary sinus with an image of higher radiological density inside, partial veiling of the anterior, posterior, and sphenoid ethmoids on the same side. Clinical treatment was started with nasal decongestant antibiotics and nasal irrigation, with which the patient had partial symptomatic relief. After two and a half months, the control SPN CT showed only improvement of the sphenoid sinus, so the patient underwent nasal endoscopic surgery, finding a more yellow-brown one in the maxillary sinus that was removed. The culture did not report fungal growth. The final diagnosis was a mycetoma or fungal ball in the right maxillary sinus plus bullous mid-shells. the patient evolved without complications. We conclude that the mycetoma as well as the other types of RSF are not so rare entities as it is believed and should always be considered within the differential diagnoses of any CSR process.

Control de epistaxis en la enfermedad Derendu-Weber-Osler: Relato de un caso y revisión de la literatura / Epistaxis control in Derendu-Weber-Osler disease: A case report and literature review

La enfermedad de Rendu-Osler-Weber-(ROW) es un padecimiento hereditario causante de sangrados de variadas localizaciones siendo lo más frecuente la epistaxis, puede comprometer la vida del paciente si las hemorragias son abundantes y muy frecuentes. Presentamos el caso de un paciente que acudió a la consulta externa de ORL del Hospital Vozandes Quito en el mes de septiembre del año 2002, presentando una epistaxis severa de fosa nasal derecha que fue controlada en forma efectiva en base a una adecuada exploración endoscópica y utilización de cauterización eléctrica solamente en el sitio del sangrado y bajo visión directa. El paciente salió del hospital sin ningún taponamiento y hasta la fecha no a vuelto a presentar sangrados importantes. Concluimos que durante una epistaxis causada por la enfermedad de ROW o por otra causa, se debe realizar una valoración adecuada de la cavidad nasal sea por un examen convencional o por endoscopía, con el fin de identificar el sitio de la hemorragia y actuar sobre el; no recomendamos ante una epistaxis realizar taponamientos nasales a ciegas como procedimiento estándar.

Rendu-Osler-Weber disease (ROW) is an inherited condition that causes bleeding from various locations, epistaxis being the most frequent, it can compromise the patient's life if bleeding is abundant and very frequent. We present the case of a patient who attended the ENT outpatient clinic at the Hospital Vozandes Quito in September 2002, presenting a severe right nostril epistaxis that was effectively controlled based on adequate endoscopic examination and use. of electric cauterization only at the bleeding site and under direct vision. The patient left the hospital without any tamponade and to date has not returned to show significant bleeding. We conclude that during an epistaxis caused by ROW disease or another cause, an adequate evaluation of the nasal cavity should be carried out either by a conventional examination or by endoscopy, in order to identify the site of the hemorrhage and act on it; We do not recommend blind episodes of nasal plugging as a standard procedure.

Analise das emissoes otoacusticas transientes em criancas com e sem risco auditivo

O registro das Emissoes Otoacusticas (EOA) e um exame objetivo para avaliar o funcionamento coclear atraves da medicao da atividade biomecanica das celulas ciliadas externas do orgao de Corti. Trata-se de um metodo valido para triagem neonatal. Nas EOA transientes (EOA-T) em termos de triagem, podem-se obter respostas presentes, parciais e ausentes, considerando-se a incidencia de apresentacao e a magnitude de resposta. A magnitude de resposta em decibeis (dB) e maior quanto mais alta a atividade biomecanica coclear. O objetivo foi comparar a incidencia de apresentacao de respostas e a magnitude de respostas das EOA-T em criancas com e sem risco auditivo; comparar as diferencas nas intensidades de respostas em criancas com e sem risco auditivo; determinar se o risco auditivo tem importancia sobre os resultados obtidos. Foram estudadas, de agosto de 1997 a julho de 1998, 96 criancas com idade menor de 12 meses, sendo 184 ouvidos testados com EOA-T. Desses, 81 ouvidos com risco e 103 sem risco auditivo. Nas criancas sem risco, a incidencia de respostas normais foi de 90,3 por cento, com uma magnitude de resposta de 21,6 dBSPL em media, 2,9 por cento tiveram resposta parcial e 6,8 por cento respostas ausentes. Nas criancas com risco auditivo, a incidencia de apresentacao de respostas normais foi de 81,5 por cento, com uma magnitude de respostas de 16,8 dBSPL em media, 4,9 por cento respostas parciais e 13,5 por cento ausentes. Foi observada uma incidencia maior de respostas normais com uma magnitude significativamente nas criancas sem risco auditivo, sendo essa diferenca significativa (p<0,01). Nas criancas com risco, a incidencia de apresentacao de respostas normais foi menor do que no grupo sem risco. As intensidades de respostas nas criancas com risco foram menores do que no grupo sem risco. A presenca de risco auditivo tem influencia na incidencia de apresentacao e nas intensidades de respostas das EOA-T.

Estudio clínico comparativo de los efectos indeseables de los anticonceptivos orales / Comparative clinical study of the undesirable effects of the oral contraceptives

Se estudiaron 31 pacientes seleccionadas de entre 45 mujeres usuarias de anticonceptivos orales de las comunidades de San Simón y San Juan (provincia de Bolívar), que fueron divididas en dos grupos homogéneos y comparables, según si usaron un preparado monofásico (16 pacientes) o trifásicos (15 pacientes), se registro la frecuencia de efectos indeseables en cada uno de los grupos. En el grupo monofásico se presentaron efectos indeseables en cada uno de los grupos. En el grupo monofásico se presentaron efectos indeseables en el 87.5xciento, en el trifásico 40xciento, diferencia estadísticamente significativa (alfa=0.05). El incremento de peso se registro, para el grupo monofásico, en 4 pacientes (25xciento) con una media de 14.75xciento, y en el trifásico 3 (20xciento) con una media de 8.66xciento, el incremento de presión arterial media se registro para el grupo monofásico en 5 pacientes (31,25xciento) con un promedio de 13.5mm de Hg. Solo hubo diferencia significativa de efectos indeseables monofásico vs. trifásico en la presencia de cloasma y várices. Se concluye que el preparado monofásico presenta mayor índice de efectos indeseables que el trifásico, esa diferencia es muy acentuada al comparar la presencia de cloasma y várices, por tanto consideramos que la indicación de uno u otro preparado debe ser hecha tomando en cuenta, sobre todo, estos aspectos.

Estudio clínico comparativo de efectos indeseables de los anticonceptivos orales / Comparative clinical study of undesirable effects of the oral contraceptives

Se analizó a 31 pacientes, seleccionadas de entre 45 mujeres usuarias de anticonceptivos orales de las comunidades de San Simón y San Juan (provincia de Bolívar), divididas en 2 grupos homogéneos y comparables, según si usaron un preparado monofásico (16 pacientes) o trifásico (15 pacientes), se registro la frecuencia de efectos indeseables en cada uno de los grupos. Resultados: en el grupo monofásico se presentaron efectos indeseables en el 87.5xcto, en el trifásico 40xcto, fue significativo. (alfa=0.05). Incremento de peso se registró, para el grupo monofásico en 4 pacientes (25xcto) y en el trifásico 3 (20xcto), Incremento de presión arterial media, se registró para el grupo monofásico en 5 pacientes (31,25xcto) y en el trifásico de 13,5mm de Hg. Solo hubo diferencia significativa de efectos indeseables monofásico presenta la presencia de cloasma y várices, por tanto consideramos que la indicación de uno u otro preparado debe ser hecha tomando en cuenta, sobre todo, estos aspectos.

Estudio clínico comparativo de efectos indeseables de los anticonceptivos orales / comaprative clinical Study of undesirable effects of the oral cantraceptives

Se analizó a 31 pacientes, seleccionadas de entre 45 mujeres usuarias de anticonceptivos orales de las comunidades de san Simón y San Juan (provincia de Bolívar), divididas en 2 grupos homogénicos y comparables, según si usaron un preparado monofásico (16 pacientes) o trifásico (15 pacientes), se registró la frecuencia de efectos indeseables en cada uno de los grupos. Resultados: En el grupo monofásico se presentaron efectos indeseables en el 87.5 por ciento, en el trifásico 40 por ciento fue significativo (alfa=0.05)Incremento de peso se registró, para el grupo monofásico en 4 pacientes (25 por ciento) y en el trifásico 3 (20 por ciento),Incremento de presión arterial media, se registró para el grupo monofásico...