BIO-VISEON™ is a sterile, nonpyrogenic, viscoelastic preparation of a highly purified, high molecular weight fraction of sodium hyaluronate, supplied as pre-filled glass syringe. BIO-VISEON™ contains 14 mg/ml of sodium hyaluronate dissolved in Sterile Isotonic vechile pH 7.0-7.50. This high molecular weight polymer is made up of repeating disaccharide units of N-acetyl-glucosamine and sodium glucuronate linked by β 1-3 and β 1-4 glycosidic bonds.
Clinical Pharmacology
Hyaluronic acid is a naturally occurring substance that is widely distributed in the extracellular matrix of connective tissues in both animals and man. It is present in the vitreous / aqueous humor of the eye, the synovial fluid, the skin and the umbilical cord.
BIO-VISEON™ is a specific fraction of sodium hyaluronate developed as an ophthalmo-surgical aid for use in anterior and posterior segment procedures. It is specific in that, it has high molecular weight, non-antigenic, does not cause local inflammation and has high viscosity.
Furthermore, the solution of BIO-VISEON™ is transparent, which remain in the anterior chamber for less than 6 days and protects corneal endothelial cells and other ocular structures. BIO-VISEON™ does not interfere with epithelialization and normal wound healing.
Indications and Uses
BIO-VISEON™ is indicated for use as a surgical aid in cataract extraction, IOL implantation, corneal transplantation, glaucoma filtration and retinal re-attachment surgeries.
In surgical procedures in the anterior segment of the eye, instillation of BIO-VISEON™ serves to maintain normal depth anterior chamber during surgery, allowing for efficient manipulation with minimal / no trauma to the corneal endothelium, iris and other surrounding tissues. Furthermore, its visco-elasticity helps to push back the vitreous face and prevent formation of a postoperative flat chamber.
In posterior segment surgeries BIO-VISEON™ serves as a surgical aid to gently separate, maneuver and hold tissues. BIO-VISEON™ creates a clear field of vision thereby facilitating intra and postoperative inspection of the retina and photocoagulation.
Dosage and Administration
In Cataract Surgery-IOL Implantation a sufficient amount of BIO-VISEON™ is slowly and carefully introduced (using a cannula / needle) into the anterior chamber and can be performed either before or after delivery of the lens. Injection prior to lens delivery will, however, have the additional advantage of protecting the corneal endothelium from possible damage arising from the removal of the cataractous lens.
In Glucoma Filtration Surgery, BIO-VISEON™ is injected slowly and carefully through a corneal paracentesis to reconstitute the anterior chamber. Further injection of BIO-VISEON™ can be continued allowing it to extrude into the subconjunctival filtration site and through and around the sutured outer scleral flap.
In Corneal Transplant Surgery, after removal of the corneal button, the anterior chamber is filled with BIO-VISEON™. The donor graft can then be placed on top of the bed of BIO-VISEON™ and sutured in place. Additional BIO-VISEON™ may be injected to replace the BIO-VISEON™ lost as a result of surgical manipulation.
BIO-VISEON™ is indicated in Retinal Re-attachment Surgery and slowly introduced into the vitreous.
Note: Refrigerated BIO-VISEON™ should be allowed to attain room temperature (approximately 30 minutes) prior to use.
Precautions
- Over filling the anterior or posterior segment of the eye with BIO-VISEON™ may cause increased intraocular pressure, glaucoma, or other ocular damage.
- Avoid reuse of cannula.
- Monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.
- Care should be taken to avoid trapping air bubbles behind BIO-VISEON™.
Contraindications
At present there are no contraindications to the use of BIO-VISEON™ as surgical aid in ophthalmic surgical procedures.
Care should be taken, when used in Patients with hyper sensitivity to any of the components.
Side Effects
BIO-VISEON™ is extremely well tolerated after injection into human eyes. A transient rise of intraocular pressure postoperatively has been reported in some cases. In posterior segment surgery intraocular pressure rises have been reported in some patients, especially in aphakic diabetics, after injection of large amounts of BIO-VISEON™
Storage
Store at 2°C to 8°C. Do not Freeze. Protect from light.
For single use only.
Use only if solution is clear.
Presentation
BIO-VISEON™ Pre-Filled Syringe 0.55ml |
