Reabilitação com prótese oculopalpebral após exenteração de órbita: relato de caso / Rehabilitation with oculopalpebral prosthesis after orbit exenteration: a case report / Rehabilitación com prótesis oculopalpebral después de la exenteración de la órbita: reporte de un caso

Introdução: A ressecção cirúrgica de tumores em região de cabeça e pescoço é um tratamento eficaz, mas que implica em significativa desfiguração facial dependendo da localização da lesão. Aqueles pacientes considerados curados precisam ser reabilitados estética e funcionalmente para que possam ser reintegrados às funções sociais. A prótese maxilofacial é um artefato de baixo custo, que pode resolver essa necessidade. Relato de caso: Esse artigo relata o caso de uma paciente de 19 anos submetida à exenteração de órbita para tratamento de Tumor Fibroso Solitário Retrorbitário que, após a cirurgia e radioterapia adjuvante, foi reabilitada por meio de prótese óculopalpebral em silicone. Conclusão: O caso foi considerado um sucesso e ressalta a importância do cirurgião dentista na equipe oncológica e o positivo impacto psicológico e social da reabilitação(AU)

Introduction: Surgical resection of head and neck tumors is an effective treatment, but it implies significant facial disfigurement depending on the location of the lesion. Those patients considered cured need to be rehabilitated aesthetically and functionally so that they can be reintegrated into social functions. The maxillofacial prosthesis is an artifact of low cost, which can solve thisneed. Case Report: This article reports the case of a 19-year-old patient who underwent orbit exanteration for the treatment of Solitary Retrorbital Fibrous Tumor, which, after surgery and adjuvant radiotherapy, was rehabilitated using an oculopebral prosthesis made of silicone. Conclusion: The case was considered a success and highlights the importance of the dental surgeon in the oncology team and the positive psychological and social impact of rehabilitation(AU)

Introducción: La resección quirúrgica de los tumores de cabeza y cuello es un tratamiento eficaz, pero implica una desfiguración facial significativa según la ubicación de la lesión. Aquellos pacientes considerados curados necesitan ser rehabilitados estética y funcionalmente para que puedan reintegrarse a las funciones sociales. La prótesis maxilofacial es un artefacto de bajo costo que puede resolver esta necesidad. Reporte del caso: Este artículo informa el caso de una paciente de 19 años que se sometió a una exenteración de órbita para el tratamiento del tumor fibroso retrorbital solitario, que, después de la cirugía y la radioterapia adyuvante, fue rehabilitada con una prótesis oculopalpebral de silicona. Conclusión: El caso se consideró un éxito y destaca la importancia del cirujano dental en el equipo de oncología y el impacto psicológico y social positivo de la rehabilitación(AU)

Three-dimensional design of a geometric model for an ocular prosthesis in ex vivo anophthalmic socket models.

PURPOSE: Fitting a customized ocular prosthesis for anophthalmic patients entails an artisanal labour-exhausting process and is standardly based on impression moulding of the socket, which may be anatomically inaccurate. The objective of the study was to design an impression-free socket mould with three-dimensional (3D) technology. METHODS: The ex vivo anophthalmic socket models included one silicone, one fresh pig cadaver head and three fresh-frozen human cadaver heads. After intra-socket application with iodine substance, five observers obtained eighteen low-dose cone beam computed tomography (CBCT) scans and one observer one high-dose CBCT scan of each model. The observers designed non-impression 3D moulds of the socket with 3D software. For the human cadaver sockets 3D geometric models of the ocular prosthesis were rendered from the 3D mould of the socket and the mirrored cornea of the contralateral eye. RESULTS: The posterior surface of the 3D mould was highly accurate, with a mean absolute deviation of 0.28 mm, 0.53 mm, 0.37 mm and mean upper deviation of 0.53 mm, 0.86 mm, 1.17 mm, respectively, for the phantom, pig and human model. The intra- and interobserver repeatability and reproducibility of the 3D moulds and designs was good (<0.35 mm). The largest variation in the 3D geometric model was found at the junction of the 3D mould and mirrored cornea. CONCLUSION: 3D design of an impression-free geometric model for an ocular prosthesis with low-dose CBCT is highly accurate in ex vivo anophthalmic socket models. This novel method is a critical step towards the manufacturing of 3D printed ocular prostheses and requires validation in anophthalmic patients.

Head mounted DMD based projection system for natural and prosthetic visual stimulation in freely moving rats.

Novel technologies are constantly under development for vision restoration in blind patients. Many of these emerging technologies are based on the projection of high intensity light patterns at specific wavelengths, raising the need for the development of specialized projection systems. Here we present and characterize a novel projection system that meets the requirements for artificial retinal stimulation in rats and enables the recording of cortical responses. The system is based on a customized miniature Digital Mirror Device (DMD) for pattern projection, in both visible (525 nm) and NIR (915 nm) wavelengths, and a lens periscope for relaying the pattern directly onto the animal's retina. Thorough system characterization and the investigation of the effect of various parameters on obtained image quality were performed using ZEMAX. Simulation results revealed that images with an MTF higher than 0.8 were obtained with little effect of the vertex distance. Increased image quality was obtained at an optimal pupil diameter and smaller field of view. Visual cortex activity data was recorded simultaneously with pattern projection, further highlighting the importance of the system for prosthetic vision studies. This novel head mounted projection system may prove to be a vital tool in studying natural and artificial vision in behaving animals.

Prophylactic Vancomycin Drops Reduce the Severity of Early Bacterial Keratitis in Keratoprosthesis.

BACKGROUND: Artificial cornea transplantation, keratoprosthesis, improves vision for patients at high risk of failure with human cadaveric cornea. However, post-operative infection can cause visual loss and implant extrusion in 3.2-17% of eyes. Long-term vancomycin drops are recommended following keratoprosthesis to prevent bacterial keratitis. Evidence, though, in support of this practice is poor. We investigated whether prophylactic vancomycin drops prevented bacterial keratitis in an animal keratoprosthesis model. METHODOLOGY: Twenty-three rabbits were assigned either to a prophylactic group (n = 13) that received vancomycin 1.4% drops 5 times/day from keratoprosthesis implantation to sacrifice, or a non-prophylactic group (n = 10) that received no drops. All rabbits had Staphylococcus aureus inoculation into the cornea at 7-12 days post-implantation and were sacrificed at predetermined time-points. Prophylactic and non-prophylactic groups were compared with slit-lamp photography (SLP), anterior segment optical coherence tomography (AS-OCT), and histology, immunohistochemistry and bacterial quantification of excised corneas. Corneal vancomycin pharmacokinetics were studied in 8 additional rabbits. RESULTS: On day 1 post-inoculation, the median SLP score and mean±SEM AS-OCT corneal thickness (CT) were greater in the non-prophylactic than the prophylactic group (11 vs. 1, p = 0.049 and 486.9±61.2 vs. 327.4±37.1 µm, p = 0.029 respectively). On days 2 and 4, SLP scores and CT were not significantly different. Immunohistochemistry showed a greater CD11b+ve/non-CD11b+ve cell ratio in the non-prophylactic group (1.45 vs. 0.71) on day 2. Bacterial counts were not significantly different between the two groups. Corneal vancomycin concentration (2.835±0.383 µg/ml) exceeded minimum inhibitory concentration (MIC) for Staphylococcus aureus only after 16 days of vancomycin drops. Two of 3 rabbits still developed infection despite bacterial inoculation after 16 days of prophylactic drops. CONCLUSIONS: Prophylactic vancomycin drops provided short-term benefit, but did not prevent infection. Achieving MIC in the cornea was not sufficient to prevent Staphylococcus aureus keratitis. Patients should continue to be counselled regarding the risk of infection following keratoprosthesis.

Estudo prospectivo da utilização do aloe vera nas afecções da cavidade anoftálmica em portadores de prótese ocular / Prospective study on the use of aloe vera in anoftalmic cavity with ocular prothesis

Introdução: uma das queixas apresentadas por pacientes portadores de prótese ocular é o desconforto, causado pela presença de secreção contaminada na cavidade anoftálmica. Objetivo: o intuito de minimizar este quadro e, baseados em estudos sobre os efeitos e propriedades antiinflamatórias, antibióticas e analgésicas do Aloe vera, os autores propõem, através de um estudo prospectivo, a análise da ação deste fitoterápico. Metodologia: foram selecionados 30 pacientes portadores de prótese ocular apresentando inflamação, exsudato, dor e/ou desconforto, não usuários de qualquer tipode medicamento tópico. Receberam um frasco conta gotas contendo Aloe vera, diluído em soro fisiológico na proporção de 1:1, devendo aplicar 2 gotas, 3 vezes ao dia durante 4 semanas; comparecendo ao Ambulatório de Prótese Buco Maxilo Facial da FOUSP para avaliação semanal. Foi aplicado um questionário auto-afirmativo em que os participantes da pesquisa avaliaram sua melhora atribuindo nota de 0 a 10.Resultado: observou-se que 93,3% dos pacientes obtiveram melhora com eliminação da secreção e inflamação e destes, 46,6% relataram melhora já na segunda semana;6,6% não conseguiram concluir a pesquisa por motivos diversos. Conclusão: foi observado que a aplicação do Aloe vera, quando seguida a recomendação, demonstrou ser eficaz no controle das afecções da cavidade anoftálmica.

Introduction: one of the complaints made by patients with ocular prosthesis is the discomfort caused by the presence of infected secretions in the patients. Aim: in order to minimize this framework and based on studies of the effects and anti-inflammatory properties, antibiotic and analgesic properties of Aloe vera, the authors propose, through a prospective study, the analysis of action of this herbal medicine.Methodology: it was selected 30 patients with ocular prosthesis showing inflammation, exudate, pain or discomfort, not users of any type of medicine topic. Received a dropper bottle containing Aloe vera, diluted in saline at a ratio of 1:1, and apply 2 drops, 3 times daily for 4 weeks, attending the Clinic of Maxillofacial Prosthesis FOUSP for the weekly evaluation. It was applied a self-administered so that the research participants rated their improvement by assigning a score from0 to 10. Results: it was observed that 93.3% of patients improved with the elimination of inflammation and secretion of these, 46.6% reported improvement in the second week, 6.6% could not complete the study for various reasons. Conclusion: the application of Aloe vera, when followed the recommendation has proved effective in controlling diseases of the patients.

Wide-dynamic-range APS-based silicon retina with brightness constancy.

A silicon retina is an intelligent vision sensor that can execute real-time image preprocessing by using a parallel analog circuit that mimics the structure of the neuronal circuits in the vertebrate retina. For enhancing the sensor's robustness to changes in illumination in a practical environment, we have designed and fabricated a silicon retina on the basis of a computational model of brightness constancy. The chip has a wide-dynamic-range and shows a constant response against changes in the illumination intensity. The photosensor in the present chip approximates logarithmic illumination-to-voltage transfer characteristics as a result of the application of a time-modulated reset voltage technique. Two types of image processing, namely, Laplacian-Gaussian-like spatial filtering and computing the frame difference, are carried out by using resistive networks and sample/hold circuits in the chip. As a result of these processings, the chip exhibits brightness constancy over a wide range of illumination. The chip is fabricated by using the 0.25- µm complementary metal-oxide semiconductor image sensor technology. The number of pixels is 64 × 64, and the power consumption is 32 mW at the frame rate of 30 fps. We show that our chip not only has a wide-dynamic-range but also shows a constant response to the changes in illumination.

The bioceramic implant: evaluation of implant exposures in 419 implants.

PURPOSE: To compare the rate of exposure in the immediate 3-month postoperative follow-up period with the rate of exposure after the immediate postoperative period in 419 anophthalmic patients with a bioceramic (aluminum oxide) orbital implant. METHODS: This is a retrospective, clinical case series of 419 patients who received a bioceramic orbital implant. All patients who presented to five oculofacial surgeons (D.J., S.G., J.D., S.K., L.M.) from January 1, 2000, to June 1, 2007, who received a bioceramic orbital implant and had a minimum of 3 months of follow-up were included in this study. The authors analyzed age, gender, type of surgery, implant size, peg system, follow-up duration, time of pegging, and problems encountered. The data from the patients with greater than 3 months of follow-up with exposure of the bioceramic implant are detailed in this report. RESULTS: There were 353 patients followed for 3 to 96 months with an average of 30 months of follow-up (median 23 months). Implant exposure occurred in 32/353 bioceramic implants (9.1%). Six of the 32 (19%) exposures occurred during the 90-day postoperative period (average 2.1 months). Twenty-six (81%) exposures occurred outside of the 90-day postoperative period (average 27.5 months, range 4-82 months). CONCLUSIONS: Implant exposures can occur anytime postimplant placement. This review discovered an implant exposure rate of 9.1%, with the majority of the exposures occurring after the postoperative follow-up period. Patients with porous orbital implants should be followed on a long-term basis to detect this complication.

Realization of a 15-channel, hermetically-encased wireless subretinal prosthesis for the blind.

A miniaturized, hermetically-encased, wirelessly-operated retinal prosthesis has been developed for implantation and pre-clinical studies in Yucatan mini-pig animal models. The prosthesis conforms to the eye and drives a microfabricated polyimide stimulating electrode array with sputtered iridium oxide electrodes. This array is implanted in the subretinal space using a specially-designed ab externo surgical technique that affixes the bulk of the prosthesis to the surface of the sclera. The implanted device includes a hermetic titanium case containing a 15-channel stimulator chip and discrete power supply components. Feedthroughs from the case connect to secondary power- and data-receiving coils. In addition, long-term in vitro pulse testing was performed on the electrodes to ensure their stability for the long lifetime of the hermetic case. The final assembly was tested in vitro to verify wireless operation of the system in biological saline using a custom RF transmitter circuit and primary coils. Stimulation pulse strength, duration and frequency were programmed wirelessly using a custom graphical user interface. Operation of the retinal implant has been verified in vivo in one pig for more than three months by measuring stimulus artifacts on the eye surface using a contact lens electrode.

A Mesolithic (Middle Stone Age!) Spanish artificial eye: please realize this technology is circa 7000-years-old!

In 2008, the author presented a paper at the Cogan Society which addressed an amazing ancient artificial eye recently found in Iran. That artificial eye is about 5000-years-old. A kind reader of some of JME's writings [who lives in Spain] noted this report, and called his attention to yet another artificial eye of a similar sort, but it was 2000 years older! It is dated ca. 7000 years BP [before the present] during the Mesolithic Time Period, i.e., the Middle Stone Age(!), and was unearthed in modern Spain. This artificial eye was found in situ in the right orbit of the scull of a man who died at 40-45 years of age. The man was tall, and was apparently relatively well-to-do (JME assumes this is based upon items found in the grave). The artificial eye was made of ocher (or ochre). In the artificial eye, an incised cornea (and possibly a pupil) can be identified. This prosthesis may have been inserted backwards into the orbit at the time of burial. This artificial eye was much more primitive in both shape and design than the later one discovered at "The Bumt City" in Eastern Iran. The man's body (containing the artificial eye) was found at an archaeological site in Spain called Cingle del Mas Nou i Cava Fosca, Ares del Maestro, Castellón Province. This particular body was exhumed at Cingle del Mas Nou by Profa. Dr. Carme Olària Puyoles and her team.

Late exposure of the bioceramic orbital implant.

PURPOSE: To investigate the long-term outcome of the Bioceramic orbital implant. DESIGN: A retrospective, comparative, nonrandomized study. METHODS: Data were collected from the patients receiving Bioceramic orbital implants at National Taiwan University Hospital between June 1, 2001 and November 1, 2005. The implant was wrapped with Vicryl mesh, adding anteriorly with a scleral patch graft following enucleation with primary or secondary implantation. The unwrapped implant was inserted into an eviscerated globe with posterior sclerotomy and cornea preserved. Primary or secondary placement of sleeve was performed in some patients. RESULTS: A total of 112 cases were reviewed. Four patients were excluded attributable to insufficient follow-up. The other 108 patients had a mean follow-up period of 35.8 +/- 10.6 months (range, 24 to 70 months). Fifty patients (46.3%) received the pegging procedure. Eight of 108 (7.4%) cases of late exposure were identified on average 20.7 months after implantation. We identified no cases of implant exposure in 30 cases of enucleation and eight cases of secondary implant when the implant was wrapped in Vicryl mesh and an anterior scleral cap was used. All exposures developed in eviscerated patients (70 cases): two without pegging, three with primary placement, and three with secondary placement of the sleeve. The exposure rate was higher in patients with eviscerated globes, pegged implants, and prior ocular operations (P < .005). CONCLUSIONS: Late exposures of Bioceramic implants were found after long-term follow-up, associated with evisceration, pegging, and prior ocular surgeries. The modified wrapping technique can prevent exposure following secondary implantation and enucleation.

Estudo do uso potencial da Fitoterapia na higienização de próteses oculares / Study of Phytothrerapy use in the higienization of ocular prosthesis

Introdução - A manutenção da prótese ocular é de grande importância para que possa exercer sua função de reestabelecer estética e manter a cavidade anoftámica livre de infecções e inflamações, muitas vezes causadas pelo manuseio das mesmas. Cuidados básicos como a higienização da prótese podem prolongar sua vida útil, além de garantir a integridade da cavidade anoftalmica. Como muitos pacientes portadores de prótese ocular encontram-se distantes de grandes centros, procurou-se uma alternativa para a higienização da peça através de um fitoterápico com esse potencial, como o Barbatimão (stryphnodndron polyphyllum), árvore presente em grande parte do pais. Material e métodos - Com o intuito de comprovar a eficácia desse procedimento foi realizado um experimento com seis próteses oculares imersas durante quarenta e nove dias em líquido resultante da maceração do fitoterápico. Resultados e conclusões - Concluiu-se que não houve alteração na composição físico-química da peça, podendo-se então indicar esse fitoterápico como agente higienizador de próteses oculares.

Porous orbital implants in enucleation: a systematic review.

Orbital implants have been used for cosmesis following surgical removal of the eyeball, or enucleation, for over a century. Implant design has progressed significantly in recent years with the use of porous devices, with the theoretical advantages of reduced complications and improved cosmesis. However, in some cases the theoretical benefits have not fully translated into clinical results. In this article the use of orbital implants in enucleation, with a particular focus on the newer porous biomaterials that have gained prominence over the last 15 years, is reviewed. Specific factors identified as affecting the performance of porous orbital implants include the material used, pore size, and morphology. Mechanical factors have received little consideration in the past and may form a basis for the use of higher compliance porous materials in the future. Of the porous materials in use, current clinical evidence is not sufficient to suggest either that porous implants are superior to non-porous implants, or that one material is more suited to the application than another. Future developments in this field require randomized controlled clinical trials with extensive follow-up as complications may not become evident until over 5 years post-implantation.

Experience with the polymer-coated hydroxyapatite implant after enucleation in 126 patients.

OBJECTIVE: To evaluate the new polymer-coated hydroxyapatite implant. DESIGN: Retrospective nonrandomized single-center case series. PARTICIPANTS: One hundred twenty-six patients managed with enucleation and placement of the polymer-coated hydroxyapatite implant at the Ocular Oncology Service at Wills Eye Hospital of Thomas Jefferson University. METHODS: A retrospective analysis was performed on 126 patients managed with enucleation and placement of the polymer-coated hydroxyapatite implant. MAIN OUTCOME MEASURES: Ease of placement, functional ocular motility, tissue complications, and patient satisfaction. RESULTS: The preenucleation diagnoses included uveal melanoma (n = 76; 61%), retinoblastoma (n = 34; 27%), blind painful eye (n = 8; 6%), neovascular glaucoma from intraocular tumors or retinal detachment (n = 5; 4%), and others (n = 3; 2%). Previous ocular therapies for posterior segment conditions such as plaque radiotherapy, retinal detachment repair, and chemoreduction, thermotherapy, and cryotherapy had been performed in 22% of patients (n = 27). The implant size was 20 mm (n = 103; 82%), 18 mm (n = 22; 17%), and 16 mm (n = 1; 1%). Implant preparation and placement was uncomplicated in all patients, without adhesion to surrounding tissue. Four rectus muscles were attached to the implant in all patients. Socket motility was judged to be good (n = 118; 94%), fair (n = 6; 5%), and poor (n = 2; 2%). Complications included conjunctival thinning (n = 1; <1%), pyogenic granuloma (n = 1; <1%), conjunctival cyst (n = 3; 2%), implant infection (n = 1; <1%), and implant exposure (n = 3; 2%). There were no cases of implant extrusion or allergic reaction to the polymer. Patient satisfaction was reported as good (n = 123; 98%), fair (n = 2; 2%), and poor (n = 1; <1%). CONCLUSIONS: The polymer-coated hydroxyapatite implant is smoothly placed into the orbit after enucleation without the need for additional tissue wrap. With proper placement, this implant provides satisfactory functional motility and shows favorable tissue tolerance with no clinical evidence of allergic reaction or extrusion.

Orbital reconstruction: bone-anchored implants.

The authors present their experience on reconstruction by extraoral bone-anchored implants technique, showing two patients from a total of 13, treated for orbital reconstruction. They were selected from 66 patients treated for reconstruction of orbit, ear and nose using this technique by the staff of the Department of Plastic and Reconstructive Surgery of the University of Tor Vergata, Rome, Italy. They underwent orbital emptying due to cancer pathology. Surgical technique is described in detail; its final purpose being positioning of titanium fixtures on the orbital borders, necessary to anchor the silicone epithesis. The advantages and potential limits of this technique are exposed, exposing the important role of patient's compliance. The importance of preliminary study on the patients is also emphasized and includes clinical evaluation and instrumental examination for surgical planning, completed by a photographic study in the three standard projections.Satisfactory aesthetic results were obtained by the use of this technique and the authors believe it may represent a valid option; complementary to more traditional ones, but is a first choice in patients who cannot endure major surgery or in case of failure of traditional techniques.

A Case of Candida Infection after Porous Polyethylene (Medpor(R)) Orbital Implantation

PURPOSE: To report a case of candida infection after Medpor(R) orbital implantation. METHODS: A 51-year-old man was admitted complaining of painful swelling and discharge about 3 years after orbital Medpor(R) implantation. External examination revealed signs of infection and exposure of the implant. Medpor(R) was surgically removed. In laboratory studies, white colony was detected in blood agar, potato dextrose agar, and CHROMagar. Automatic identification with yeast standard test revealed Candida parapsilosis. RESULTS: Six months after surgery, the wound had healed well. In addition, cosmesis was acceptable with the artificial eye, except mild superior sulcus deformity. CONCLUSIONS: Although rare, fungal infection of the implant should be suspected when there are the long standing signs of infection and exposure after orbital Medpor(R) implantation.

Effective electrode configuration for selective stimulation with inner eye prostheses.

The quality of visual perception with retinal prostheses strongly depends on the local selectivity. Electrode arrays at the surface of the retina should excite exclusively cells within a local area but they are expected to co-stimulate bypassing axons originating from ganglion cells of the outer regions. Long electrodes parallel to these axons are shown to be good candidates for avoiding the co-stimulation phenomenon. Efficiency of focal excitation depends on the length and resistance of the electrodes.

[New ceramic materials for use in anophthalmia surgery]. / Neue Keramikmaterialien zur Verwendung in der Anophthalmuschirurgie.

Over the last 20 years eyeball replacement surgery has improved, especially with the widely accepted use of biocolonisable implants. These implants allow long-lasting biointegration, thus improving prosthesis motility and reducing the rate of postoperative exposure. In this article, we review the chemical structure, toxicity data and manufacturing procedures of the three main commercially available materials: aluminium, hydroxyapatite and porous polyethylene.

[Anophthalmos--a conjunctival implant]. / Anoftalmus--spojivkový implantát.

The authors submit information on the completed development of a conjunctival implant and its use for modelling of the conjunctival sac in inborn and acquired anophthalmos. Plastic solution in inborn types is used for cosmetic reasons in unilateral degenerative and consecutive anophthalmos. The orbit and adnexa are usually only little affected. The other indication is secondary anophthalmos after enucleation of the bulbus when the conjunctival sac is threatened by retraction due to actionotherapy of the orbital area or a scarry process after a previous injury. The implant is a convex concave circular-shaped plate with a diameter of 20 mm the centre of which is thinner to facilitate manipulation during insertion. It is made from silicone rubber which has properties characterized as implant grade. Before the implantation proper the plate is adjusted by cutting to the desired size. The surgical procedure proper in inborn anophthalmos involves external canthotomy with gradual preparation of the conjunctiva into the Tenon space in the region of the eyelids to create a broad crevice into which the adjusted implant can be inserted. The operation is completed by closing the canthotomy supplemented by partial tarsorrhaphy using unabsorbable suture. Thus the implant is sufficiently fixed in the newly created ocular space. The silicone inlay is left for 3-6 months to allow epithelization of the surgical site round the implant. In acquired anophthalmos with retraction of the conjunctival sac in the first stage the lower transitory fold is released before insertion of the implant by the cul-de-sac method. The function of the implant is modelling of the conjunctival space in anophthalmos to maintain an adequate space for fornices for later insertion of the permanent prosthesis. The implant is manufactured at present by ELLA-CS.