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CeraEye Synthetic Hydroxyapatite Integrated Orbital Implant:
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When the eye of a person is damaged due to injury or disease, the surgeon removes the eye ball from the orbit to avoid the risk of life or risk to the other eye of the patient. Lost eye is mechanically replaced by an ocular implant to fill up the orbital volume lost after enucleation or evisceration to achieve better cosmosis and rehabilitation of the anophthalmic patient.

ConoidIFGL Bio Ceramics is pleased to introduce CeraEye Integrated Orbital Implants / Spheres made of Synthetic Porous Hydroxyapatite Ca10(P04)6(OH)2as per know-how developed by Central Glass & Ceramic Reseach Institute, Kolkata (India), a constitutent laboratory of Council of Scientific Industrial Research (CSIR), India. Unlike glass and or polymer Sphericalbased ones with which lots of disadvantages and high rate of exclusion are associated, CeraEye Orbital Spheres are made of Synthetic hydroxyapaptite material, which is both bio compatible and bio active. Term Synthetic refers to manufacturing of Hydroxyapaptite by a process which develops a highly porous, fully inter connected bio compatible ceramic matrix, which is similar in structure to natural bone. Bio compatible means a prosthesis which can fit in the human body without any reaction or rejection. Similarly, bio active means reaction of Hydroxyapatite in a postive manner to form bonds with local cells. Because of this, adjacent tissues integrate with prosthesis and provide stability and motion to the same.

pegsCeraEye Integrated Orbital Implant / Sphere are also porous and thus have the ability to accept a motility / support peg. When fully vascularized, they can support complete epithelialization of the internal surfaces of the peg hole, thereby healing the implant from external environment and preventing infection. Presnetly
Coralline-derivedhydroxyapatite ocular implants are also used for reconstruction after enucleation and evisceration, however main draw backs thereof are

  • Tailor making of orbital implant with respect to porousity and pore size is not possible.
  • Rough outer surface of the implant abrades the overlying conjucnctiva and Tenon's capsule.
  • Implant can not be used as such without wrapping with donor sclera or coating.
  • Additional Surgery is needed to harvest a donor sclera
  • Chances of HIV infection through donor sclera. CeraEye Synthetic Hydroxyapaptite Orbital Implant takes care of aforesaid drawbacks in as much as is an ocular implant with tailor made properties with respect to total mass, porosity, pore size and surface roughness. Tailor made ocular implant is not possible with coralline desirved calcium hydroxyapatite.

Following are the Advantages, Salient Features, Characteristics of CeraEye Synthetic Hydroxyapatite Orbital Implant / Spher

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Important Links
Council of  Scientific and Industrial Research
Society for Bio Medical Technology
Clinical References
Development of Bio Active Integrated Ocular Implant for Anophthalmic Patients by Dr D Basu and Others
Fabrication and characterisation of porous hydroxyapatite ocular implant followed by an in vivo study in dogs by Dr Basu & Others
Synthetic hydroxyapatite based integrated orbital implants - A human pilot trial (Synopsis)
Synthetic hydroxyapatite based integrated orbital implants - A human pilot trial
Development of bio-active integrated ocular implant for anophthalmic human patients
News Reviews
Science and Technology and Earth Sciences
Visual Aid Gift from City's Ceramic Centre
Bio Active Eye Minus Sight
CSIR Press Release 12th May, 2005
Advantages
  • Made of Bio compatible and Bio active material
  • Extremely light weight
  • Provide good eye movement
  • Has very low exposure problem
  • Has Porous structure for Vascularisation meaning design is engineered to be 70% porous with pore sizes ranging from 100 to 300 microns. Result is within six months of surgery, tissues and blood vessels encompass the orbital implant / sphere and as a result implant move freely providing good movement. Porous structure permit fibrovascular ingrowth into the implant which facilitate its stability within the eye socket.
Salient Features
  • Inert and Bio compatible
  • Biochemically Stable
  • Light Weight
  • In Conoid and Spherical Design
  • Smaller than Eye Ball
  • Centered within Muscle Cone
  • Integration to EO Muscle
  • Anchored to Orbital Tissue
  • Stability and Integration in Eye Socket
  • Resilient
  • Much more increased Motility
  • Operational Convenience
  • Direct Integration with Prosthesis
Characteristics
Composition Synthetic Hydroxyapatite

Formula

Ca10(P04)6(OH)2
Bulk Density 0.6 - 0.7 gms/cc
Specific Weight < 2 gms
Porosity 70% - 75%
Pore size (by SEM Micrograph ) 100 - 300 m
Unit Volume 3 - 4 cc
Flexural Strength for solid HAP > 25 MPa
Compressive Strength for solid HAP > 120 MPa
Sizes 14,16,18,20 mm
Shapes Spherical, Coroid
Types Evisceration, Enucleation

Following are the short term post operative results of  gamma ray sterilized CeraEye Synthetic Hydroxyapaptite Orbital Implants placed in orbital cavity with and without wrapping in a donor sclera.

Volume replacement Ideal (about 3 CC)

Weight

Ideal (< 2 gms)
Bio - acceptability Excellent (none of the implants showed any side effect)
Post operative appearance Perfect (no signal of any kind of post-enucleation socket syndrome ie no sign of retraction or ptosis of the upper eye lid / deep upper lid sulcus / lax lower eye lid / enophthalmic appearance)
Rate of Fibrovascularisation

Excellent and all the implants were integrated to the orbit within few days of transplantation

Movement of the eye ball in horizontal direction Excellent
Movement of the eyeball in vertical direction Very Good

CeraEye Synthetic Hydroxyapatite Orbital Spheres / Implants are moderately priced and available in sizes of 14 mm, 16 mm, 18 mm and 20 mm in spherical and conoid designs. Conoid design is available both in plain and drilled hole models for evisceration / enucleation purposes. CeraEye Implant / Sphere is supplied in specially designed tamper proof blister pack after Gamma Ray Sterilisation.


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