Complex Case Management includes the treatment of naturally occurring or surgically-induced corneal irregularities with customized laser treatments.
VISX? Custom Contoured Ablation Profile (C-CAP) humanitarial devise exemption study for post-LASIK and post-PRK patients
Studies in Follow-up Stages
Device and Procedure Description
The C-CAP method is intended for people who suffer from visually related symptoms caused by irregularity of the cornea after excimer laser treatments. These individuals may be experiencing some hazy or blurred vision where they may complain that their vision just isn't as clear and crisp as it was with their glasses or contact lenses. They may also experience glare and halos while driving at night.
The C-CAP procedure involves the use of a diagnostic topography-based unit, which measures the curvature of the cornea. Our surgeons use this information along with the the C-CAP method's software program to plan and create an ablation pattern customized to the unique needs of the person's eye. This customized reshaping of the cornea is intended to reduce visual distortion.
Minnesota Eye Consultants was one of several sites nationwide who participated in the use of the C-CAP method, which is authorized for use by the Food and Drug Administration under a Humanitarian Device Exception (HDE). An HDE authorizes the marketing of a device that is intended to aid in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States per year. Eligible subjects had irregular astigmatism and visual disturbances as a result of a decentered ablation. Subjects were followed for at least six months.
Study History- Complex Case Management
Clinical evaluation of BioMask? as an adjunct to Phototherapeutic Keratectomy (PTK)
Excimer laser therapy for pterygium or superficial corneal scar removal, epithelial irregularities, and fungal or bacterial ulcers and anisometropia
A Phase II prospective multi-center clinical trial to evaluate the use of the excimer laser for the treatment of superficial corneal opacities