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Section 6
CLINICAL USE
6.1
Introduction
LightLink-CXL Corneal Cross-linking System is a specialized Ophthalmic Medical Device
controlled by sophisticated PC embedded software integrated with the system. The
system emits a low level UV-A light of 365nm, produced by the UV LED (Light Emitting
Diode) Cluster, through a specialized Optical Module producing a homogeneous spot
size and power controllable beam, intended for delivery on Corneal Surface.
The intention of the device is to allow a non-invasive treatment of Corneal disorders
utilizing a controllable ultraviolet light in a procedure clinically referred to as Corneal
Cross-linking.
Main Indications for Use:
The LightLink-CXL Corneal Cross-Linking System is being increasingly renowned as the
most innovative and revolutionary para-surgical procedure designated for treatment
numerous corneal disorders such as keratoconus, iatrogenic ectasia, post LASIK ectasia,
pellucid marginal degeneration.
Riboflavin Use in Cross-Linking:
Procedure involves irradiating the cornea by the UV-A light as generated by the cross
linking system, in conjunction with an independent Riboflavin (vitamin B2) solution, that
acts as a stimulant being photosynthesized by the UV-A on the corneal tissue, and
equally acting as a safety filer, creating a superficial barrier on the cornea preventing the
UV-A rays from reaching the inner retina.
Riboflavin is administered in form of droplets onto the cornel surface and is thus an
essential element of each corneal cross-linking procedure.
It is available and should be applied in two formulations as:
-
Isotonic solution (Riboflavin 5-phosphate (0.1%) plus 20% Dextran T500)
-
Hypotonic solution (Riboflavin 5-phosphate (0.1%))
Isotonic or Hypotonic solution is administered depending on the different levels of
corneal thickness, assuring the optimum treatment safety, in line with the recognized
corneal cross linking treatment protocols. The physician must measure and asses the
corneal thickness prior to each procedure using additional diagnostic equipment.
Summary of Contents for LightLink CXL
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