ABSTRACT
PURPOSE: The goal of this phase III, comparative, multicentric, randomized, double-blinded clinical trial was to investigate the superiority of subconjunctival bevacizumab injections versus placebo in the treatment of corneal neovascularization. PATIENTS AND METHODS: We included 38 eyes (38 patients) with corneal neovascularization. Twenty patients received bevacizumab and 18 placebos. Patients received 3 monthly injections of either 5mg (0.2mL) bevacizumab or placebo. The main criteria of success was reduction of the surface area of corneal neovascularization after 3months (M3) versus baseline, as measured using semi-automatic analysis of color photographs. RESULTS: The percentage of neovascularized corneal surface decreased by -8.6%±32.8 with bevacizumab, versus -2.6%±20.8 with placebo (p=0.5284). Four patients were determined to be responders (reduction of more than 30%), 3 in the bevacizumab group and 1 in the placebo group, all with neovascularization of less than 1year duration. When restricting the analysis to neovascularization of less than 1 year duration, the difference approached the threshold for significance (-31.8%±42.4 in the bevacizumab group and -0.9%±23.1 in the placebo group) (p=0.0637), as well as the number of responders (3/6 in the bevacizumab group versus 1/10 in the placebo group) (p=0.1181). No serious adverse event was reported. CONCLUSION: This study shows the efficacy of subconjunctival bevacizumab injection in the reduction of neovascularized corneal surface area versus placebo, but only when the neovascularization has been present less than 1year. Nevertheless, the study did not attain the statistical power to pass the threshold of significance.
ABSTRACT
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.
Subject(s)
Contact Lenses, Hydrophilic , Myopia , Humans , Atropine , Myopia/diagnosis , Myopia/therapyABSTRACT
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.
