Instructions for Use
NAME OF PRODUCT:
Viscoelastic gel for use in ocular surgery
Viscoelastic solution indicated for use as a surgical aid in the surgery of the anterior segment of the eye such as cataract surgery, intraocular lens (IOL) implantation, corneal transplantation surgery and glaucoma filtering surgery.
Sodium hyaluronate 2%, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.
The solution is isotonic (270-330 mOsmol/kg) with pH ranging from 6.8 - 7.5.
DOSAGE AND ADMINISTRATION:
The content and outer surface of the VISIOL® pre-filled syringe are sterile as long as the sterile pack remains unbroken. Take the pre-filled syringe out of the sterile pack, unscrew the Luer-Lock cap, attach a suitable needle (for example ophthalmologic needle 25 G) and secure by turning slightly. Remove any air bubble, if present, before injection.
Cataract surgery and IOL implantation: VISIOL® can be used at any stage of the cataract surgery to create a deep anterior chamber, protect the tissues and facilitate the IOL implantation. Extrude the required amount of VISIOL® slowly and carefully into the anterior chamber through a cannula. VISIOL® may also be used to coat the surgical instruments and IOL before insertion. Additional VISIOL® can be injected during surgery, if needed.
Corneal transplant surgery: Remove the corneal button and fill the anterior chamber with VISIOL® until it is level with the surface of the cornea. Place the donor graft on top of VISIOL® and suture into place. Additional VISIOL® can be injected during surgery, if needed.
Glaucoma filtering surgery: Inject the required amount of VISIOL® slowly and carefully into the anterior chamber through a paracentesis when performing the trabeculectomy. Additional VISIOL® can be injected during surgery, if needed.
CHARACTERISTICS AND MODE OF ACTION:
Sodium hyaluronate (SH), the active principle in VISIOL®, is a polysaccharide which consists of repeating sequences of glucuronic acid and N-acetylglucosamine. It is present in the extracellular matrix, in particular in the vitreous humour, the synovial fluid and the umbilical cord. The highly purified SH, obtained by fermentation in VISIOL® has an average molecular weight of 1.7-1.8 million daltons. VISIOL® exhibits a pseudoplastic flow behaviour, i.e. the viscosity decreases when the shear rate is increased. The extrapolated zero-shear viscosity is approximately 60,000 mPas tested in compliance with ISO 15798.1
1. VISIOL® helps create and maintain anterior chamber depth and visibility at all stages of the anterior segment surgery and minimises interaction between tissues during surgical manipulation.
2. VISIOL® protects intraocular tissues, such as the corneal endothelium, from damage due to the use of surgical instruments. VISIOL® may also be used to coat the surgical instruments and IOL before insertion.
3. SH protects the corneal endothelium against damage caused by free radicals.2 In addition, mannitol contained in VISIOL® acts as a free radical scavenger, slows down the degradation of sodium hyaluronate long chains by reactive oxidative species and therefore helps maintain the rheological properties of SH during phacoemulsification in cataract surgery.3, 4
4. VISIOL® preserves tissue integrity and provides good visibility during eye surgery.
PRECAUTIONS AND SIDE EFFECTS:
The normal precautions associated with eye surgery should be observed to avoid intra- and/or post-operative increase in intraocular pressure (IOP).5, 6 The product must be administered with care and under close monitoring, particularly in patients with pre-existing glaucoma and in cases of glaucoma surgery. If intra-ocular pressure rises above normal after surgery, appropriate treatment should be provided. The product should be removed by irrigation and/or aspiration at the end of the procedure. Clinical trials have shown that VISIOL® did not cause clinically significant increase in IOP if some product remained in situ after the surgery.7
For detailed information please refer to the instructions for use.
Results of acute, sub-acute and chronic toxicity studies together with the results of foetal toxicity, fertility, peri-and post-natal toxicity studies show that SH is well tolerated.
Avoid using VISIOL® with instruments sterilised with quaternary ammonium salts solution.
STORAGE AND SHELF-LIFE:
Store between 2-25°C in original sterile pack. Do not freeze. Shelf life of 3 years if stored in original unopened packaging at the correct temperature.
One pre-filled syringe of 20 mg/1.0 ml VISIOL® in a sterile pack.
To be used by a physician only.
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1. International Standard ISO 15798. 2001 Ophthalmic implants - Ophthalmic Viscosurgical Devices.
2. Artola A, Alio JL, Bellot JL, Ruiz JM. Cornea 1993; 12(2):109-14.
3. Mendoza G et al. Carbohydr Res 2007;342:96-102.
4. Belda JI, Artola A, Garcıa-Manzanares MD, Ferrer C, Haroun HE, Hassanein A, Baeyens V, Munoz G, Aliò JL. J Cataract Refract Surg 2005; 31:1213–8.
5. Lane SS, Naylor DW, Kullerstrand LJ, Knauth K, Lindstrom RL. J Cataract Refract Surg 1991; 17(1):21-6.
6. Holzer MP, Tetz MR, Auffarth GU, Welt R, Volcker HE. J Cataract Refract Surg 2001; 27(2):213-8.
7. TRB Chemedica SA: Data on file.