Active clinical trials for "Keratoconus"

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

To evaluate and compare the effect of pulsed light (pl-ACXL) accelerated and continuous light accelerated (cl-ACXL) epithelium-off cross-linking in halting the progression of keratoconus.

This is a prospective, Phase I open-label safety study to evaluate the safety, feasibility and initial efficacy of a bioengineered corneal stromal substitute after implantation into the stroma of adults with advanced keratoconus. The bioengineered substitute and implantation technique may provide a less invasive treatment option for advanced keratoconus than current surgical approaches, that additionally does not rely on the limited availability of human donor corneal tissue.

The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.

The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.

Three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.

Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.