A randomised study comparing performance and safety of Eyestil Plus® vs Vismed Multi® in moderate-to-severe dry eye syndrome patients.

PURPOSE: This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients. MATERIALS AND METHODS: This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety. RESULTS: 96 participants were randomised to receive the clinical investigations' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study's objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events. CONCLUSION: This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.

Efficacy and safety of intense pulsed light delivered by the C.STIM® for treatment of Meibomian gland dysfunction.

INTRODUCTION: Intense pulsed light (IPL) appears to be a promising treatment for Meibomian gland dysfunction (MGD), the most common cause of dry eye disease. C.STIM® is a new IPL device. We report the first safety and efficacy study in clinical practice. MATERIALS AND METHODS: Patients with moderate MGD treated with C.STIM® were included. Three IPL sessions were performed at D0, D15 and D45 with 4 shots per side (fluence of 8J/cm2). Clinical evaluation was performed at D0, D45 and M3 with several parameters: BUT, OSDI and Oxford scales, meibomian gland evaluation (morphology, quality and expressibility of meibum). The Lacrydiag® imaging device was used for objective evaluation of interferometry, meibography, tear meniscus height and NIBUT. The primary endpoint was the change in NIBUT between D0 and M3. Data collection was retrospective. Longitudinal analysis and a non-parametric linear mixed-effects model (R software) were used for statistical analysis. RESULTS: Thirty-five patients were included. NIBUT increased significantly between D0 and M3, with a mean difference of 2.6seconds (95% CI 2.0; 3.1, P<0.001). The other parameters studied also changed significantly, except for meibography (percentage of loss and morphology) and tear meniscus height. No adverse event was noted. CONCLUSION: C.STIM® appears safe and effective in the treatment of MGD, although a randomized controlled trial is needed to validate these results.

Who first described Descemetorhexis without endothelial keratoplasty (DWEK) for the management of Fuchs' corneal endothelial dystrophy?

We present here in a historical focus on the first descriptions in the 1950's by Louis Paufique of Descemetorhexis without endothelial keratoplasty (DWEK) for the treatment of Fuchs' endothelial dystrophy. This article places the introduction of this surgical technique in the context of its time, describes its principles, and puts into perspective the place of this relevant treatment in the therapeutic arsenal of today and tomorrow.

[Corneal perforation with tyrosine kinase inhibitor chemotherapy: REGORAFENIB]. / Perforation cornéenne sous chimiothérapie inhibiteur des tyrosines kinases : REGORAFENIB.

INTRODUCTION: Tyrosine kinase inhibitors (TKIs) are active in a variety of metastatic cancers. They have a good general tolerance with mainly hepatic and dermatological side effects. Rarely, ophthalmologic side effects may occur: eyelash abnormalities, eyelids abnormalities, disorders of the ocular surface with ocular dryness or even corneal erosions that can even lead to perforation. Regorafenib is a new oral multi-targeted tyrosine kinase inhibitor that inhibits multiple protein kinases, including those involved in tumor angiogenesis, oncogenesis and tumor microenvironment. CASE DESCRIPTION: We describe, to the best of our knowledge, the first case of complicated bilateral ulcers of corneal perforation in a patient under REGORAFENIB. OBSERVATION: 20-year-old patient with metastatic chondrosarcomas of the pelvis, mandible and thorax received chemotherapy with REGORAFENIB. A few weeks after initiation of treatment, he experienced an increased dry eye syndrome associated with bilateral corneal ulcers complicated by perforation. Despite discontinuation of chemotherapy and maximal medical and surgical treatment (iterative amniotic membrane grafts and corneal transplantation), the progression was unfavorable. DISCUSSION: This is the first known case of corneal perforation under REGORAFENIB. The pathophysiology is multifactorial. On the one hand, this chemotherapy targets angiogenesis (VEGFR), oncogenesis (KIT, RET, RAF1, BRAF) and the tumor microenvironment (PDGFR, FGFR). On the other hand, other triggers are added, namely mixed dry eye syndrome, hypovitaminosis A (anorexia), the neurotrophic component, as well as the toxicity of chemotherapy via tears. CONCLUSION: First described case of corneal perforation under REGORAFENIB, non-regressive at the end of chemotherapy, and despite medical and surgical treatments. Ophthalmologic surveillance is therefore necessary for patients under chemotherapy with tyrosine kinase inhibitors, as serious ocular complications, especially corneal ones, may occur.

[What will cataract surgery look like in the future? Alternatives in the pipeline]. / Que sera la chirurgie de la cataracte du futur ? Alternatives et voies de développement.

Phacoemulsification is the most frequently performed surgery in the world. Over the past few years, this surgery seems to have reached a plateau with no further innovative breakthroughs. In this paper, we focus on alternatives techniques, the latest innovations, and the research and development pipeline in this field.

Monitoring of visual field over 6 months after active ocular toxoplasmosis.

PURPOSE: To prospectively report the perimetric defects during a 6-month follow-up (FU) in patients with initially active ocular toxoplasmosis (OT). METHODS: Twenty-four patients were studied, including 11 eyes with chorioretinal toxoplasmosis proven with a positive aqueous humor sample and 13 eyes with a biologically unproven, chorioretinal lesion. Automated 24-2 SITA-Standard visual fields were performed at baseline, at the first, and sixth months of FU. A composite clinical severity score was calculated from visual acuity (VA), severity of vitreitis, chorioretinal lesion size, location of the lesion in zone 1, the presence of an initial macular or papillary edema, and long-term scarring. This provided a relative cutoff level of severity. Nine eyes out of the 24 eyes were considered severe (3 unproven and 6 proven OT). RESULTS: Initial and final visual field parameters (mean deviation [MD] and pattern standard deviation [PSD]) were significantly correlated (r = 0.873; p < 0.001, and r = 0.890; p < 0.001, respectively). During FU, only foveal threshold [FT] was correlated with VA at baseline (r = 0.48; p = 0.01) and at the 6-month FU visit (r = 0.547; p = 0.004). The MD initial predictive value of clinical severity was 0.739 according to the ROC curve. At baseline, severe and nonsevere OT exhibited no significant difference in term of MD (p = 0.06) and PSD (p = 0.1). During the FU, taking into account all the data, MD, PSD, visual function index [VFI], and FT were associated with the severity of toxoplasmosis (p = 0.018, 0.05, 0.016, and 0.02, respectively): the unproven group had a faster recovery of MD during FU (p = 0.05). CONCLUSION: Visual field parameters better reflected the chorioretinal destruction related to the toxoplasmosis lesion and the functional repercussions than VA alone. Interestingly, MD at presentation could be a discriminating factor of severity in active OT, and each visual field parameter follow-up could be a support to manage patients with active OT, especially in the severe group.