Hydrogel orbital implant

Soft hydrogel orbital implant for after eye bulbus enucleation

(credited to Prof. Vanysek PhD)

 
 There are various materials and shapes for orbital implants which have been tested and implanted over the years. The majority of these implants are manufactured of either hard (PMMA, natural corral, and synthetic hydroxyapatite) or semi-soft (silicone) but none have contained water. The Human eye is predominately mainly made up of water; e.g. vitreous body contains 98% water and cornea 75%. The variations in properties of ocular implants until now compared to the natural eye may be a contributing factor to an implant irritation in the eye-socket, conjunctiva dehiscence which in servear cases may lead to the implant rejection and extraction. Which in turn can lead to other potentially serious complications.

A new form of Orbital implant developed by Wilens s.r.o. in the Czech Republic who have almost 30 years’ experience in hydrogel development have manufactured of a new biomimetic soft acrylate orbital implant containing 44% water. The shape is based on a lengthy time-proven design that incorporates specially designed apertures for attaching the muscles, which was developed by the famous Czech ophthalmologist Professor Vanýsek. The combination of orbital shape, muscle apertures, material and polymer manufacturing know-how has produced a unique product that offers surgical and patient benefits compared to the current available hard orbital implants.

(Vanysek, J.:  Orbital Implants of Artificial Resins, Českoslov. oftal. 7:319-329, 1951).

Features and Benefits of HOI

• Maintains Natural Lid Shape offering a more visually natural enhancement. 
• Offers a Natural Biocompatibility of the orbital environment to give healthier tissue acceptance.
• Allows real Integration with less surgical complications.
• Reduced complications associated "synthetic implant syndrome"
• Indicated for Primary enucleation, evisceration and secondary implantation
• Made of 44% Hydrogel material
• Lightweight
• Easy to insert
• Low tissue reaction offering greater acceptance in the orbital environment
• Available in 3 sizes 15mm, (Juvenile) 17mm, and 19mm.
• Class IIb sterile medical device
• EN ISO 13485 ed. 2:2016 approved.

HOI a Soft hydrogel implant is made of a biomimetic material that has been used in the manufacture of contact and intraocular lenses for more than 30 years. In a clinical study of 40 patients fitted with the HOI Soft Hydrogel Implants over a 2 years period showed that out of the 40 subjects none experienced any adverse reaction, rejection or complications from the implanted device.  Therefore, it can be reasonably demonstrated that inserted soft Hydrogel Implant HOI will show to have minimum occurrences of conjunctiva and muscles erosion above the implant and thus the risk of conjunctiva dehiscence, infection and implant reject should be reduced to a minimum. The HOI Soft Hydrogel Implant requires no wrap technique that has shown prolongs and complicates the surgery. From known experience based on over 30 years using a biomimetic material in intraocular lenses, implanted material does not degrade nor show signs of calcification.

The HOI Hydrogel orbital implant is a custom-made medical device manufactured under ISO 13485:2016 standard, requiring no CE mark certification; however, patient and surgeon identification is needed on all correspondence and ordering form. 

HOI is supplied in a double sterile packaging (bag and bottle with saline) in 3 sizes:  “L  19mm (for men), M 17mm (for women) and  S 15mm (for juveniles)