Subconjunctival Sirolimus-Loaded Liposomes for the Treatment of Moderate-to-Severe Dry Eye Disease.

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.

Results of one decade of optical keratoplasty in pediatric patients.

BACKGROUND: Keratoplasty in the pediatric population has been considered a high-risk procedure. OBJECTIVE: To know the demographic data of patients younger than 18 years treated with optical keratoplasty, indications for surgery and its results. MATERIAL AND METHODS: A retrospective study was carried out at Conde de Valenciana Ophthalmology Institute, in which the medical records of patients younger than 18 years treated with optical keratoplasty from 2009 to 2019 were analyzed. RESULTS: A total of 53 eyes were included. The most common diagnosis and procedure were keratoconus and penetrating keratoplasty, respectively. Mean initial visual acuity was 2.05 ± 0.99 logMAR, and 0.82 ± 1.33 at last visit. Survival time was 130.34 months. Four failures were recorded. As for associated surgeries, corneal wound closure was recorded in seven eyes prior to transplant; during the keratoplasty procedure, anterior vitrectomy in two eyes, and after the transplant, Ahmed valve implantation and re-suture. A total of eight eyes had glaucoma, five of them diagnosed prior to transplantation. Regarding rejection, 15 eyes had an episode during follow-up, and mean time to transplant rejection was 10.8 months. CONCLUSION: Prolonged graft survival can be achieved with better knowledge and management of different associated factors.

ANTECEDENTES: La queratoplastia en población pediátrica ha sido considerada un procedimiento de alto riesgo. OBJETIVO: Conocer datos demográficos de pacientes menores de 18 años tratados con queratoplastia óptica, indicaciones de la cirugía y sus resultados. MATERIAL Y MÉTODOS: Se realizó un estudio retrospectivo en el Instituto de Oftalmología Conde de Valenciana, en el que se revisaron expedientes de pacientes menores de 18 años tratados con queratoplastia óptica de 2009 a 2019. RESULTADOS: Un total de 53 ojos fueron incluidos. El diagnóstico y el procedimiento más comunes fueron el queratocono y la queratoplastia penetrante. El promedio de agudeza visual inicial fue de 2.05 ± 0.99 logMAR y en la última visita, 0.82 ± 1.33. El tiempo de supervivencia del injerto fue de 130.34 meses. Se registraron cuatro fallas. En cuanto a las cirugías asociadas, antes del trasplante se registró cierre de herida corneal en siete ojos y durante la queratoplastia, vitrectomía anterior en dos ojos y después del trasplante, implante de válvula de Ahmed y resutura. Un total de ocho ojos tuvieron glaucoma, cinco con diagnóstico antes del trasplante. Respecto al rechazo, 15 ojos tuvieron un episodio durante el seguimiento y el tiempo promedio de rechazo al trasplante fue de 10.8 meses. CONCLUSIÓN: Se puede lograr una supervivencia prolongada del injerto con el mejor conocimiento y manejo de los diferentes factores asociados.

Resultados de una década de queratoplastia óptica en pacientes pediátricos / Results of one decade of optical keratoplasty in pediatric patients

Resumen Antecedentes: La queratoplastia en población pediátrica ha sido considerada un procedimiento de alto riesgo. Objetivo: Conocer datos demográficos de pacientes menores de 18 años tratados con queratoplastia óptica, indicaciones de la cirugía y sus resultados. Material y métodos: Se realizó un estudio retrospectivo en el Instituto de Oftalmología Conde de Valenciana, en el que se revisaron expedientes de pacientes menores de 18 años tratados con queratoplastia óptica de 2009 a 2019. Resultados: Un total de 53 ojos fueron incluidos. El diagnóstico y el procedimiento más comunes fueron el queratocono y la queratoplastia penetrante. El promedio de agudeza visual inicial fue de 2.05 ± 0.99 logMAR y en la última visita, 0.82 ± 1.33. El tiempo de supervivencia del injerto fue de 130.34 meses. Se registraron cuatro fallas. En cuanto a las cirugías asociadas, antes del trasplante se registró cierre de herida corneal en siete ojos y durante la queratoplastia, vitrectomía anterior en dos ojos y después del trasplante, implante de válvula de Ahmed y resutura. Un total de ocho ojos tuvieron glaucoma, cinco con diagnóstico antes del trasplante. Respecto al rechazo, 15 ojos tuvieron un episodio durante el seguimiento y el tiempo promedio de rechazo al trasplante fue de 10.8 meses. Conclusión: Se puede lograr una supervivencia prolongada del injerto con el mejor conocimiento y manejo de los diferentes factores asociados.

Abstract Background: Keratoplasty in the pediatric population has been considered a high-risk procedure. Objective: To know the demographic data of patients younger than 18 years treated with optical keratoplasty, indications for surgery and its results. Material and methods: A retrospective study was carried out at Conde de Valenciana Ophthalmology Institute, in which the medical records of patients younger than 18 years treated with optical keratoplasty from 2009 to 2019 were analyzed. Results: A total of 53 eyes were included. The most common diagnosis and procedure were keratoconus and penetrating keratoplasty, respectively. Mean initial visual acuity was 2.05 ± 0.99 logMAR, and 0.82 ± 1.33 at last visit. Survival time was 130.34 months. Four failures were recorded. As for associated surgeries, corneal wound closure was recorded in seven eyes prior to transplant; during the keratoplasty procedure, anterior vitrectomy in two eyes, and after the transplant, Ahmed valve implantation and re-suture. A total of eight eyes had glaucoma, five of them diagnosed prior to transplantation. Regarding rejection, 15 eyes had an episode during follow-up, and mean time to transplant rejection was 10.8 months. Conclusion: Prolonged graft survival can be achieved with better knowledge and management of different associated factors.

Reliability, repeatability, and accordance between three different corneal diagnostic imaging devices for evaluating the ocular surface.

Purpose: To evaluate repeatability, reproducibility, and accordance between ocular surface measurements within three different imaging devices. Methods: We performed an observational study on 66 healthy eyes. Tear meniscus height, non-invasive tear break-up time (NITBUT) and meibography were measured using three corneal imaging devices: Keratograph 5M (Oculus, Wetzlar, Germany), Antares (Lumenis, Sidney, Australia), and LacryDiag (Quantel Medical, Cournon d'Auvergne, France). One-way ANOVAs with post hoc analyses were used to calculate accordance between the tear meniscus and NITBUT. Reproducibility was assessed through coefficients of variation and repeatability with intraclass correlation coefficients (ICC). Reliability of meibography classification was analyzed by calculating Fleiss' Kappa Index and presented in Venn diagrams. Results: Coefficients of variation were high and differed greatly depending on the device and measurement. ICCs showed moderate reliability of NITBUT and tear meniscus height measurements. We observed discordance between measurements of tear meniscus height between the three devices, F2, 195 = 15.24, p < 0.01. Measurements performed with Antares were higher; 0.365 ± 0.0851, than those with Keratograph 5M and LacryDiag; 0.293 ± 0.0790 and 0.306 ± 0.0731. NITBUT also showed discordance between devices, F2, 111 = 13.152, p < 0.01. Measurements performed with LacryDiag were lower (10.4 ± 1.82) compared to those of Keratograph 5M (12.6 ± 4.01) and Antares (12.6 ± 4.21). Fleiss' Kappa showed a value of -0.00487 for upper lid and 0.128 for inferior lid Meibography classification, suggesting discrete to poor agreement between measurements. Conclusion: Depending on the device used and parameter analyzed, measurements varied between each other, showing a difference in image processing.

Cool Crosslinking: Riboflavin at 4°C for Pain Management After Crosslinking for Keratoconus Patients, A Randomized Clinical Trial.

PURPOSE: To explore corneal cooling as a method of pain management in corneal-accelerated collagen cross-linking. METHODS: This was a prospective and interventional randomized clinical trial registered in the National Institutes of Health Clinical Trials through the identifier NCT030760770. The research was conducted at the Institute of Ophthalmology "Conde de Valenciana." A total of 98 patients were randomly assigned to one of the following 2 groups: cold riboflavin (4°C) group or control group (riboflavin at room temperature). The inclusion criteria were patients of any sex, older than 18 years of age with keratoconus diagnosis who needed management with cross-linking in both eyes because of the evidence of progression. The exclusion criteria were patients who had cross-linking without epithelial debridement, unilateral cross-linking, or any other ocular pathologies besides keratoconus and any cognitive incapacity that would make the understanding of the pain test difficult. The main outcome measures were pain, tearing, photophobia, foreign body sensation, and irritation. RESULTS: At 2 hours post-op, pain in the case and control groups was 3.80 ± 3.00 and 8.08 ± 2.21 (P < 0.05), tearing was 1.56 ± 1.96 and 8.29 ± 2.42 (P < 0.05), photophobia was 5.44 ± 3.57 and 7.83 ± 2.64 (P < 0.05), foreign body sensation was 2.20 ± 2.78 and 6.54 ± 2.73 (P < 0.05), and irritation was 3.48 ± 2.98 and 6.79 ± 3.00 (P < 0.05), respectively. A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]). CONCLUSIONS: This study demonstrated that pain and associated symptoms decreased significantly in the riboflavin 4°C group.