VEGA RICROLIN_Depliant 3 ante_BIANCA INGLESE

Surgical procedure
(Riboflavina 0,1%)
Ophthalmic solution for parasurgical use
Package
1 sterile pre-filled
monodose dispenser
Technical procedure
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1 Tabl. Paracetamolo 500mg - Codeine 30mg (Co-Efferalgan BMS) or 1 Tabl. Ketorolac 10mg (Lixidol).
Cleanse ocular surface and instill:
Ofloxacin collyrium 1-2 drops
Cyclopentolate 1-2 drops
Flurbiprofen 1-2 drops
• Control pedal
• Fixation point
• Incorporated telecamera with focus controller
• Improved irradiation consistency thanks to the excellent UV
illuminator, integrated with innovative optical system
• Built on a stand with wheeled base
RICROLIN® is an ophthalmic solution containing Riboflavin 0.1%. This solution is
instilled in the eye during irradiation of UV-A light as part of the parasurgical procedure of corneal collagen cross-linking. The principal objective of RICROLIN® is to provide
a barrier against UV-A penetration beneath the corneal stroma, and thus protect the
delicate internal structures of the eye (corneal endothelium, lens and retina) from
damage that may be caused by radiation. RICROLIN® solution is in fact capable of
reducing up to 95% of the UV energy that reaches the deep strata of the cornea.
Indications
In association with ophthalmic UV-A radiation, the solution is administered during
conservative parasurgical procedures for keratoconus and other corneal estasia
pathologies.
In particular the treatment is indicated in the following conditions:
- Diagnosed Keratoconus and/or secondary ectasia on the basis of clinical,
topographical and pachymetrical analyses
- Clinically and instrumentally diagnosed Progressive Keratoconus
The administration of RICROLIN® in association with UV-A light retards the
progression of Keratoconus.
This treatment can prevent the necessity of corneal transplant.
This treatment does not exclude the possible need of keratoplasty in the future.
• Balanced operating arm
Characteristic of UVA source
Single LED for UV-A rays
Maximum wavelength: 370nm
Width of ray: 8nm
Power density of irradiation
3mW/cm2 (nominal)
Accuracy: ± 10%
Diameter of radiated area
Between 4 -11 mm (@ 54mm)
Collimation system
Couple of red LED
Telecamera
Monitor
Integrated with optic head
Colour micro-telecamera
Colour, 5.6 inch
Dimensions
1000 x 545 x 1280 mm
Composition
100ml of solution contains:
Riboflavin phosphate 0.127 g (equivalent to 0.1g of basic Riboflavin); Destrane
T500 20g
Excipients: Bihydrate sodium phosphate monobasic, Bihydrate sodium
phosphate bibasic, Sodium chloride, Distilled water q.b. for 100g
1,0
Contraindications
There are no known contraindications associated with the ophthalmic solution.
Use must be avoided in cases of hypersensitivity reactions to the components of
the product or to other chemically-related substances
0,8
The therapy begun in the surgical phase, to be repeated 4 times a day, continueing until removal of the
contact lens (4-5th day). The CL to be removed on completion of the re-epithelialization. Topical medications
after surgery should be continued for 15-20 days (according to medical advice) and consist of:
Ofloxacin collyrium 1-2 drops 4 times a day
Flurbiprofen 1-2 drops 4 times a day
Trium eye drops 1-2 drops 4 times a day for at least 3 months
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Precautions
• The product must be kept away from direct light
• Right up to the moment the product is to be utilised, it must be stored under
refrigeration at a temperature between +4 and +8°C
• Kept within its dispenser, the solution is maintained sterile
• Do not touch the eye surface or other objects with the cannula needle in
order to avoid the risk of contamination to the solution
• Do not utilise the product after more than one hour from first use
• Do not utilise the dispenser for more than one patient
• Do not utilise the product after the date indicated on the package
• Do not keep the product in temperature over 25°C
• The product is strictly indicated for external ophthalmic parasurgical use and
is therefore utilised exclusively by registered Ophthalomologists.
• Do not utilise product if packaging is damaged
Package
1 monodose sterile dispenser filled with 1 ml solution
1 sterile single-use cannula needle
Relative emission
Side Effects
No systemic or eye structure related side-effects have been reported
Postsurgery medication
Innovative approach
in the treatment of
keratoconus
• Adjustable diaphragm to vary the treatment area
Instructions for use
10-15 minutes prior to irradiation, instil 1 or 2 drops of the product using the
appropriate dispenser provided and repeat treatment every 5 minutes. During
treatment with UV-A light instil 1 or 2 drops of the solution every 5 minutes for
a total of 30 minutes.
Intrasurgery medication
• Timer and Monitor to observe all procedure steps
www.oncomunicazione.com
Instructions of surgical procedure.
• 30 minutes before surgery instill Pilocarpine 2% eye drop once only
• Topical anesthesia: instill Lidocaine 4% three times in 15 minutes
• Calibration test by means of power meter: 3mW/cm2 (”POWER ON CHECK” displayed)
• Patient positioning under surgical mircroscope and blepharostate placement
• Mark the corneal area and carry out the disepithelisation of 9mm diameter using blunt spatula
• Instill 1 drop of Lidocaine 4% again
• Instill 4-6 drops of Ricrolin (Riboflavin solution 0.1%)
• Position optical head above the patient and align for accurate focusing
• Press pedal: from ”POWER ON CHECK” to “STEP 0” (imbibition phase)
• After 10-15 minutes press pedal again to return to “WAIT” phase
• Width of UV-A light spot must be 8mm in diameter
• Instil 2 or more drops of Ricrolin at the beginning of each phase
• Press pedal to start “STEP 1” wich will last 5 minutes. The system will than pass automatically to the
“WAIT” phase and then the next step
• Proceed to subsequent phases until completion of all phases
• After step 6 the system will automatically return to “POWER ON CHECK”
• Cleanse ocular surface with sterile saline solution, administer intrasurgery medication and position
therapeutic contact lens (CL).
1 sterile single-use
cannula needle
TECHNICAL CHARACTERISTICS
0,6
Made by
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Worldwide
exclusivity for
OOFTA Hi-tech
Division of
SOOFT Italia
0,2
300
350
370
400
450
1 ml.
Bibliography
Aldo Caporossi, Cosimo Mazzotta e Stefano Baiocchi:
Principi, indicazioni, tecnica e risultati del Cross-Linking corneale Riboflavina + UV-A nella terapia
del cheratocono evolutivo, editore I.N.C.
Aldo Caporossi MD, FRCS, Cosimo Mazzotta MD, PhD, Stefano Baiocchi MD, PhD:
Technological Innovations in Corneal Collagen Cross-Linking. Ophthalmology Times Europe,
September 2007
OOgroup - SOOFTitalia S.p.A.
C.da Molino,17 - 63025 Montegiorgio (FM)
Tel. +39 0734 964096 - Fax +39 0734 964551
www.sooft.it [email protected]
www.oogroup.it
INNOVATIVE APPROACH IN THE TREATMENT OF PROGRESSIVE
KERATOCONUS AND OTHER CORNEAL ECTASIA PATHOLOGIES
(Riboflavina 0,1%)
Ophthalmic solution for parasurgical use
RICROLIN IS A STERILE AND
SINGLE-DOSE FORMULA,
IN COMPLIANCE WITH GLP
Technical characteristics
RICROLIN DOES NOT CONTAIN PRESERVATIVE
AGENTS
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LCD Monitor
• Colour micro-telecamera with
LCD monitor integrated within
the optical head to capture
images of the procedure in real
time
• Narrow LED array for UV light distribution
• Adjustable iris diaphragm from 4 to 11 mm to
vary the area to be treated, while maintaining the 3mW/cm2 power density constant
• Collimation system with intermittent red
light LED for accurate focalisation
• Coaxial green fixation light
Easy to use
Video-acoustic system with monitor provides the operator with all scanning
information on time and procedure phases.
Timing of each step is
recorded in minutes
and seconds
Indicates the STATUS
of the system
(WAIT, RUN, PAUSE, RESET)
00:00
• Protects the endothelium and the sensitive
ocular structure (riboflavin reduces the
intensity of the UV light rays by 95%)
pared to the 20 months of ordinary stability)
demonstrate that the riboflavin concentration is higher than 97%
Data collected after 24 months
(in accordance with the Siena Eye Cross Project – A. Caporossi, C. Mazzotta, S. Baiocchi - Università di Siena)
PARAMETER
K TOPOGRAPHIC VALUE
UCVA
BSCVA
SYMMETRY
Control pedal guarantees sterility and separate
operating activity of operator
Stability tests (accelerated by 5 months com-
FOLLOW UP (AVERAGE RESULTFROM 44 EYES TREATED)
REDUCTION OF > 2 D
IMPROVEMENT OF 2,7 SNELLEN LINES
IMPROVEMENT OF 1,9 SNELLEN LINES
IMPROVEMENT > 70%
• Balanced arm on wide wheeled base for
comfortable use
• Control Pedal
• Wide working range
(54mm) for confortable
manoeuvering
Emission consistency
100
90
The single LED provides
the energy needed ensuring more than 90% on a
surface area of irradiation
of max. 11 mm diameter emisssion percentage
80
percentage of emission
• Produces oxidative reagent species
STEP 0
Stability
Riboflavin in Cross-linking:
• Absorbs UV light rays
WAIT
70
60
50
40
30
Others instruments
CSO Vega
Max
20
10
0
5,0 4,5 4,0 3,5 3,0 2,5 2,0 1,5 1,0 0,5 0,0 -0,5 -1,0 -1,5 -2,0 -2,5 -3,0 -3,5 -4,0 -4,5 -5,0
ABERRATIONS
Indicates each
STEP of the
procedure
SIGNIFICANT REDUCTION IN COMATIC ABERRATIONS
Keratoconus was stabilized in 100% of the patients
area of irradiation