Use of allogeneic platelet-rich plasma for the treatment of autoimmune ocular surface disorders: case series

PurposeTo assess the effectiveness of topical allogeneic platelet-rich plasma (PRP) eye drops for the treatment of symptoms and clinical signs in patients with severe dry eye disease as a secondary condition caused by Sjögren’s syndrome (SS).DesignCase series and literature review.MethodsSix eyes from three consecutive patients with severe dry eye from SS were evaluated. The eyes were treated with allogeneic topical PRP eye drops, with one drop applied six times daily for 3 months. A post-treatment follow-up evaluation was conducted 3 months after treatment suspension. We evaluated subjective symptoms, visual acuity, tear breakup time, the results of Schirmer’s I test, fluorescein corneal and conjunctival staining, and corneal sensitivity.ResultsThe symptoms and visual acuity improved significantly in all patients. There was a significant improvement in corneal sensitivity and a decrease or disappearance of fluorescein corneal staining.ConclusionThe treatment with allogenic PRP eye drops of patients with SS-related severe dry eye disease has proven to be very effective, with an improvement in symptoms and main clinical signs

Stargardt Phenotype Associated With Two ELOVL4 Promoter Variants and ELOVL4 Downregulation: New Possible Perspective to Etiopathogenesis?

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A Randomized, Controlled Trial of Cyclosporine A Cationic Emulsion in Pediatric Vernal Keratoconjunctivitis: The VEKTIS Study

Purpose Vernal keratoconjunctivitis (VKC) is a chronic, allergic, and potentially severe ocular disease affecting children and adolescents that can lead to impaired quality of life (QoL) and loss of vision. This study evaluated the efficacy and safety of an investigational therapy for severe VKC, cyclosporine A (CsA) cationic emulsion (CE), an oil-in-water emulsion with increased bioavailability versus conventional CsA formulations. Design The VErnal KeratoconjunctiviTIs Study (VEKTIS) is a phase 3, multicenter, double-masked, vehicle-controlled trial. Participants Pediatric patients (4 to younger than 18 years) with active severe VKC (grade of 3 or 4 on the Bonini severity scale) and severe keratitis (corneal fluorescein staining [CFS] score of 4 or 5 on the modified Oxford scale). Methods One hundred sixty-nine patients were randomized to CsA CE 0.1% (1 mg/ml) eye drops 4 times daily (high dose), CsA CE twice daily (low dose) plus vehicle twice daily, or vehicle 4 times daily for 4 months. Main Outcome Measures The primary end point was a mean composite score that reflected CFS, rescue medication use (dexamethasone 0.1% 4 times daily), and corneal ulceration over the 4 months. Results Differences in least-squares means versus vehicle for the primary end point were statistically significant for both the high-dose (0.76; P = 0.007) and the low-dose (0.67; P = 0.010) groups, with treatment effect mainly driven by CFS score. Significant differences were found between both active treatment groups and vehicle for use of rescue medication. Vernal keratoconjunctivitis symptoms and patient QoL (assessed by visual analog scale and the Quality of Life in Children with Vernal Keratoconjunctivitis questionnaire) improved in all 3 groups, with significant improvements for high-dose CsA CE versus vehicle. Conclusions The efficacy of high-dose CsA CE in improving keratitis, symptoms, and QoL for those with severe VKC was demonstrated in these study patients. In addition, in this study cohort, CsA CE was well tolerated

12-Month Results of Cyclosporine A Cationic Emulsion in a Randomized, Study in Patients With Pediatric Vernal Keratoconjunctivitis

Abstract Purpose To assess the safety and efficacy of cyclosporine A cationic emulsion (CsA CE) 0.1% eye drops in pediatric patients with severe active vernal keratoconjunctivitis (VKC). Design Multicenter, double-masked, randomized control trial 8-month safety analysis Methods Of 169 patients (age range, 4-17 years) initially randomized in the 4-month VEKTIS study, 142 entered the 8-month follow-up period during which CsA CE patients remained on their original regimen (CsA CE four times daily [QID, high-dose] or CsA CE twice daily [BID, low-dose] + vehicle BID) and vehicle patients were allocated to one of these 2 active regimens. Main outcome measures were safety, including treatment-emergent adverse events, and efficacy, including corneal fluorescein staining (CFS) score. Results Improvements in CFS score, rescue medication use, key VKC symptoms (photophobia, tearing, itching, and mucous discharge), and quality of life (QoL) assessed by QUICK questionnaire observed with CsA CE compared with vehicle during the 4-month evaluation period remained stable during the 8-month follow-up period, with the high-dose regimen continuing to provide greater benefits in most efficacy measures. CsA CE was well tolerated. Treatment-related treatment-emergent adverse events during the 12-month study were reported in 15 (20.8%) and 11 (15.7%) of the CsA CE high-dose and low-dose patients, respectively, most commonly instillation site pain (13.9% and 7.1%), respectively). Laboratory data, vital signs, slit lamp examination, best-corrected distance visual acuity, and intraocular pressure raised no safety concerns. Conclusions Improvements in keratitis, symptoms, and QoL achieved after CsA CE treatment for 4 months remained stable over the 8-month follow-up period. CsA continued to maintain a favorable safety profile

Variability in the orbital profiles of the X-ray emission of the gamma-ray binary LS I +61 303

We report on the analysis of Rossi X-ray Timing Explorer (RXTE) Proportional Counter Array (PCA) monitoring observations of the $\gamma$-ray binary system LS I +61 303, covering 35 full cycles of its orbital motion. This constitutes the largest continuous X-ray monitoring dataset analyzed to date for this source. Such an extended analysis allows us to report: a) the discovery of variability in the orbital profiles of the X- ray emission, b) the existence of a few (recent) short flares on top of the overall behavior typical of the source, which, given the PCA field-of-view, may or may not be associated with LS I +61 303, and c) the determination of the orbital periodicity using soft X-ray data alone.Comment: The Astrophysical Journal Letters (2010), in pres

Trehalose protects the corneal epithelium in alcohol delamination: a structural and ultrastructural study

During laser subepithelial keratomilieusis (LASEK) the corneal epithelium undergoes to peculiar morphological changes owing to the dilute alcohol used to facilitate its mechanical separation from the stroma. As it was shown that trehalose, a non-reducing disaccharide of glucose, protects corneal epithelial cells from drying [1] and is effective in the treatment of experimental [2] and of human dry eye [3], aim of the present work was to evaluate the advantages of a pretreatment with trehalose to improve the structural and ultrastructural features of the corneal epithelium. Twelve patients undergoing LASEK were consecutively included in the study and treated as follows: topical anesthesia with oxybuprocaine hydrochloride 0.4 %, 20% ethanol in distilled water for 25 seconds followed by Merocel wetting, treatment with hypotonic BSS in distilled water, lifting of the epithelial flap with a beaver blade, excimer laser treatment (0.8 mm flying spot), reposition of the epithelial flap, BSS wash of the entire surface, application of a contact lens for 5-7 days. The right eyes of each patient were pretreated, together with the anesthetic, with 3% trehalose eye drops, whilst the left eyes were used as controls. Small parts of the epithelium were collected with a forceps at the end of the epithelial reposition and were processed for light and transmission electron microscopy. From the micrographs obtained with both techniques a morphometric analysis was also performed. In the controls, the corneal epithelium showed flat superficial cells with well-preserved apical microfolds, wing cells with intracellular vesicles and slightly dilated intercellular spaces, and irregularly shaped basal cells filled with vesicle, separated by wide spaces. In the trehalose-treated epithelium superficial cells showed normal shape, regular apical microfolds and well-preserved intercellular borders; wing cells had a well evident cytoskeleton, sometimes apparently double nuclei and normal intercellular borders, glued by desmosomes. The basal cells demonstrated polygonal shape, round nuclei and evident intracytoplasmic vesicles. The morphometric analysis carried out on the height and on the number of the layers of the corneal epithelium demonstrated in the trehalose-treated group values significantly lower than the control group. Similarly, basal hemidesmosomes were more numerous in the trehalose-treated group when compared to the control group. The morphological changes of the corneal epithelium during LASEK represent a simple and reproducible experimental model to evaluate the antagonists of an acute stress, such as the alcohol delamination. Our results demonstrate that trehalose administration before LASEK is able to maintain better morphological and morphometric features when compared to the control cornea