ophthafutur silicone oils offer a variety of viscosities.
High patient and product safety
Multi-step proven and tested ultra-purification process
Safe, biocompatible, sterile, endotoxin-free products
3 years shelf life
THE ISSUE
manufacturing-related impurities
risks of silicone oil endotamponades
With silicone oils, as with all polymers, the characteristics are determined by chain length and chain length distribution.
Risks originate from volatile and short-chained components which are generated during production. These components can penetrate into tissue and damage cells.
Due to the combination of hydrophobicity and polarity, silicone oils can act as a trap for many impurities that can destabilize the tamponade (“emulsification”), even in low concentrations.
OUR ANSWER
multi-step ultra-purification process
our response: ultra-purified silicon liquids
ophthafutur® silicone oils are ultra-purified according to a multi-step FDA approved process, which is succesfully performed since 1998.
By combining extraction, thermal treatment and filtration, all critical impurities are separated.
The materials of the primary containers are selected to prevent any recontamination during manufacturing and storage.
purity criteria for silicone oils
In addition to the well-established GC-MS methods, the control of the removal of short-chained compounds by gel permeation chromatography (SEC) is an ophthafutur® standard.
usability
intended use
Silicone oils are used as ocular endotamponades in cases of severe retinal detachment, e.g. solid proliferative vitreo-retinopathy, traumatic detachment and giant tears, as well as other detachments of the retina, which cannot be treated with other forms of therapy.
Silicone oil can be injected into the eye with the support of vitrectomy machines. An adapter kit of the ophthafutur® line will support the oil injection.
Silicone oils exhibit a density < 1 g/cm3. For this reason the oil will float on water.
The eye should be completely filled with silicone oil to avoid cavities which may still contain water or gas.
To avoid high intraocular pressure, the patient should be monitored postoperatively. Due to the lower density, an iridectomy at 6 o’clock should be considered.
Emulsifications are one of the known side effects of oil injections and can be triggered by various reasons.
In addition to the precondition of the patient, the quality of the injected oil may play a role. The likelihood of emulsifications can be reduced by using ultrapurified oil.
The standard glass syringe, which is widely used in ophthalmology has a plastic luer lock at the tip. For added protection of the luerlock and safer handling, a mechanical support tube is shrunk over the tip.
For additional information please consult directions for use.