Product Performance - Thickness Of Corneal Flaps; Contraindications; Warnings - MORIA CBm-ALTK CBSU Manuel Utilisateur

Important: CBm (#19332/xxx), CBSU (#19312/xxx) and CBSU heads for artificial chambers (#19178/
xxx) have a stop that prevents a complete (hingeless) resection CB (#19309/xx) on the patient when
used with CB rings (#19309/xx). The use of these devices entails creating a hinge on the recipient's
eye. Only CBm-ALTK heads have no stops and allow a complete resection on the patient.
5.3 PRODUCT PERFORMANCE – THICKNESS OF CORNEAL FLAPS
The thickness of the corneal flap is a key factor in lamellar keratoplasty. Many parameters can affect the
thickness of the flap and its predictability (standard deviation). Numerous scientific studies have shown
the effect of many patient-related factors on the thickness of the corneal flap such as keratometry (K), the
anatomy of the cornea, the preoperative pachymetry, intraocular pressure (and the pressure in the artificial
chamber for preparing the donor graft), as well as factors related to the surgery itself such as corneal
hydration and the travel speed of the mechanical microkeratome.
Ultrasound pachymetric measurements are not always accurate or reproducible, so results can vary
depending on the technique and calibration of the equipment.
For CBm-ALTK heads, for example, a MORIA head calibrated as "130" cuts, on average, a corneal flap of
160 microns:
• "130" corresponds to a measurable dimension in the head of the microkeratome (distance between
the blade and plateau).
• 160 microns is the average thickness that this head cuts with variations around this average.
Head (nominal)
130
200
250
300
350
400
For CBSU heads for artificial chambers, see the document «Selecting CBSU heads to prepare ultrathin
lamellar grafts» (#65082).
Moria can only guarantee the dimensional characteristics of the head, not the surgical result.
The surgeon is strongly advised to carry out tests beforehand to determine the thickness and diameters of
the expected cuts based on his/her own technique.

5.4 CONTRAINDICATIONS

CBm-ALTK ((#19170/xxx) heads and CBSU heads for artificial chambers (#19178/xxx) must not be
used in any way for a LASIK procedure due to the thickness of the resections obtained.
Important: CBm (#19332/xxx), CBSU (#19312/xxx) and CBSU heads for artificial chambers (#19178/
xxx) have a stop that prevents a complete (hingeless) resection CB (#19309/xx) when used with CB
rings (#19309/xx). The use of these devices entails creating a hinge on the recipient's eye.

5.5 WARNINGS

• The design of CBm blades and CBSU heads for artificial chambers does not allow them to be
used under any circumstances. Reusing these products degrades their clinical performance
and exposes the patient to adverse reactions.
• Do not use materials and/or components with the CB microkeratome that are not made by Moria.
• CBm blades must be inserted by hand. Do not use tools or pliers. Incorrect assembly can produce
an incomplete or defective cut due to improper oscillation of the blade.
6
MORIA #65078-B-02.2017
Increment
+30
+50
+60
+70
+85
+100
Average depth of cut
160
250
310
370
435
500