Progressive Keratoconus Clinical Trial
Official title:
The Safety and Effectiveness of Collagen Cross Linking With Riboflavin and Ultraviolet-A Light in Progressive Mild and Moderate Grades of Keratoconus.
The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus.
Keratoconus is a corneal degeneration characterized by bilateral conical protusion and
corneal thinning. The course of the disease varies from slight irregular astigmatism to
severe visual impairment due to increasing protrusion and subepithelial scarring. There is
no treatment available that can stop keratoconus progression. Thus, because of its
progressive nature, keratoconus is the most frequent reason for keratoplasty worldwide in
the past 3 decades.
The collagen crosslinking (CXL) technique using riboflavin and ultraviolet - A (UVA) light
was recently developed to counteract the progressive corneal thinning, and thus the
progression of keratoconus. With crosslinking, additional covalent binding between collagen
molecules can be achieved, which stabilizes the collagen scaffold and enhances corneal
resistance.
Prospective longitudinal randomized case-control study including progressive keratoconus
cases is addressed to evaluate the effectiveness of collagen cross linking (CXL) in reducing
progression of mild and moderate progressive keratoconus. Progression is based on increase
in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent
or increase of the anterior chamber depth on Pentacan, in a period of at least six months.
All patients must be between 15 and 40 year old and are randomized and allocated in the
treated or the control groups. Complete exam before and after exam included best corrected
visual acuity, refraction, IOP, fundoscopy, imaging exams such as corneal computerized
topographic, pentacan, orbscan, ultrasound pachymetry, esthesiometry, endothelial cell
count, HRT II system confocal microscopy, optic coherence tomography (VISANTE), ORA , optic
coherence tomography (Stratus OCT) and dynamic contour tonometry . All the exams are
repeated 1, 3, 6 and 12 months after the procedure. The cross linking is performed as
follows: after topical anesthesia, the epithelial tissue is removed in a 8.0mm diameter area
of the central cornea, the 0,1% riboflavin solution is applied every 2 min, for 30 min
followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance
of 3 mW/cm2. During the irradiation, drops of the riboflavin solution is continuously
applied onto the cornea every 5 min.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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