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FAQ's on CeraEye Synthetic Hydroxyapatite Orbital Implant
What is Enucleation ?
Enucleation is the surgical removal of the entire eye
What is evisceration ?
Evisceration is the surgical removal of the contents of the eye, leaving the white part of the eye (sclera) and the eye muscles intact.
Why enucleation and eviscerations are necessary ?

A. Removal of an eye may be required to control pain in a blind eye, following a severe injury where functional repair is not possible, to treat malignant tumors inside the eye, if there is a severe un-treatable infection inside the eye, or for cosmetic improvement of an unsightly eye. Other indications include:

  • Prevention or treatment of sympathetic ophthalmitis.
  • Iridocyclitis, phthisis bulbi, and glaucoma when accompanied by severe pain or inflammatory symptoms.
  • Anterior staphyloma, if the eye is blind, troublesome and disfiguring;
  • Intraocular foreign bodies which cannot be removed and which cause irritation.
How it is decided which procedure to be carried out ?
Eviseration is the procedure of choice for most patients as it has better cosmetic and functional results (movement of artificial eye) with a lower complication rate. Enucleation is carried out if the eye is being removed to treat an intraocular tumor, or if the underlying disease causing blindness / disfigurement is not known.
How is the surgery performed ?

Both procedures are performed under general anesthesia, although they can be completed safely using local anesthesia with sedation. After removal or the eye or its contents, an implant is inserted in the eye socket to replace the lost volume. The implant is a sphere and is covered by the patient’s own tissue.

Following enucleation, the eye muscles are attached to the implant in order to preserve eye movement.

What are the risks and complications associated with these surgeries?
Immediate post-operative risks for this surgery, as with any surgery, include bleeding and infection. Longer-term complications include dryness, discharge, socket irritation or rarely exposure of the implant. As with any medical procedure, there may be other inherent risks that should be discussed with your surgeon.
Is Donor's Sclera required for transplantation of CeraEye Synthetic Hydroxyapatite Orbital Implant ?
Advantage with CeraEye Synthetic Hydroxyapatite Orbital Implant is that it can be directly transplanted in the patient thereby eliminating donor's sclera, which sometimes carry contaminated HIV germs.
 
How is CeraEye Synthetic Hydroxyapatite Orbital Implant superior than conventional ones ?

CeraEye Synthetic Hydroxyapatite Orbital Implant not only fill up orbital volume lost after enucleation or evisceration but also provide adequate mobility for better cosmesis and rehabilitation of anophthalmic patient. Clinical performance is far better than the available ones made of materials such as metal, glass, polymers etc, which have been not only found to be incompatible with host but also static. CeraEye  has very good properties for vascularisation and this is evidenced on magnetic resonance imaging.

 
Is CeraEye Synthetic Hydroxyapatite Orbital Implant mechanically stable in long term in the post operative period ?

There is no possibility of CeraEye Synthetic Hydroxyapatite mechanically disintegrating in the post operative period. This is despite material being highly porous and fragile. Orbital Implant remain well protected within the socket which is sufficiently hard and unless there is an accident of serious nature causing direct blow or punch to the eye, material is not likely to disintegrate. Even in worst case if HAP (Synthetic Hydroxyapatite) material in small quantity remains within the socket, no problem is feared because of its highly bio-compatible nature.

 
Is surgical technique and level of skill required to perform surgery with CeraEye Synthetic Hydroxyapatite Orbital Implant different than that relating to transplantation of conventional implants ?

Taking out natural eye ball is not much of a problem. Any qualified surgeon can do this. For insertion of implant, standard accepted surgical technique with some modification is followed. Eye surgeons with a few years of experience are able to operate with high degree of success. Whole operation does not require any specialised skill.

 
Have Cercinogenicity and mutagenecity tests been done on Synthetic Hydroxyapatite Orbital Implant ?

Synthetic Hydroxyapatite is being used now nearly for three decaces in the field of Orthopaedic and in other areas of medicines without any adverse effects and non-cercinogenicity of this material is proved beyond doubt.

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