Active clinical trials for "Keratoconus"

We investigated the use of a copper sulfate eye drop (IVMED-80) for the treatment of keratoconus. Preliminary laboratory data shows that the addition of copper sulfate increase crosslinking of the structural proteins of the cornea thereby halting the progressing corneal thinning and bulging seen in keratoconus. We conducted a Phase 1/2a study to evaluate the safety and preliminary efficacy of a 6-week and a 16-week regimen using IVMED-80 and studied its impact on ocular safety and the change/progression in patients' vision and clinical measurements.

The overall goal of this project is to improve the visual quality of individuals who have abnormal corneal conditions that alter the shape of their cornea (eg. keratoconus). Patients with an abnormal corneal shape have substantial lower and higher order aberrations (distortions in the eye). This results in reduced visual acuity which cannot be corrected by regular sphero-cylindrical correction. Compensating for these aberrations has been challenging due to difficulty measuring their wavefront aberrations accurately and, consequently, manufacturing the custom contact lenses with irregular optical profiles. This project is designed to systematically overcome these obstacles with a customized scleral and/or soft contact lens capable of compensating for the lower and higher order aberrations of the eye.

The most common causes for irregular cornea (IC) in hospital contact lens practice are Keratoconus (KC) and related cornea thinning disorders. These conditions cause mild to marked impairment of vision and cannot be effectively corrected by spectacles and soft contact lenses. The gold standard in the management of KC is Corneal Rigid Gas Permeable contact lenses (corneal lenses), which correct approximately 90% of the corneal irregularity. Compared with a normal cornea, the cornea in KC is irregular and this results in a compromise to the fit of rigid corneal lenses. Specifically, they bear on the cornea and this, together with the vulnerability of the cornea in KC, are implicated in corneal scarring, and disease progression as well as a significantly reduced vision related quality of life (QoL) in KC compared with corneal lens wearers who have no KC. In cases where the compromise fit of corneal lenses proves problematic, large diameter Scleral RGP contact lenses (scleral lenses) may be used as a problem solver. Unlike the smaller corneal lenses which bear on the cornea, the scleral lenses completely bridge over the cornea and bear on the sclera. The aim of this research is to investigate the performance of scleral lenses in KC participants who habitually wear corneal lenses. The research question: is there a measurable difference in the visual performance and visual quality of life in participants with Irregular cornea disorders like keratoconus and other related conditions, who habitually wear corneal lenses in comparison with scleral lenses.

The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation. In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.

The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.

Young patients with keratoconus face two problems: disease progression and corneal shape irregularity leading to poor vision even in spectacles. Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression in keratoconus. The aim is to stiffen the cornea thereby preventing further shape deterioration. Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal shape irregularity in early stage keratoconus, reducing dependence on contact lenses. In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure, preparing the cornea for CXL. Performing both treatments simultaneously (combining both procedures in one operation) may offer several advantages over performing CXL first then waiting for corneal shape to stabilise before performing transPRK. In particular, visual rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients will be compared with results for a similar group of patients with early stage keratoconus who have already been treated with CXL alone.

Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the surgical outcomes: minimally invasive procedures, improved biomechanical stability of the transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of infections risk, faster healing process. In order to achieve these goals, two different lasers were used during PK surgery: a femtosecond laser to cut an anvil shaped profile a diode laser to weld the surgical wound

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Epithelium-On Corneal Crosslinking for Keratoconus.

Corneal crosslinking (Crosslinking, CXL) is a treatment offered for the stabilization of early corneal ectatic disorders such as keratoconus. Although CXL is an excellent treatment option to stabilize early ectatic corneas, complications include corneal haze, sterile infiltrate, endothelial cell toxicity, treatment failure and stromal scarring. Corneal haze is a common finding in almost all CXL patients and may decrease visual quality. The effect of 0.02% mitomycin C (MMC) for 2 minutes on corneal haze and scarring in refractive surgery is well established in the literature with many clinical studies confirming its effectiveness. Although the pattern of corneal haze after CXL appears to be different from the haze pattern seen following refractive procedures, both processes are thought to be caused by an inflammatory response. The investigators postulate that MMC can reduce post-CXL haze and scars when using the optimal concentration and duration of exposure.