Clinical application of biomaterials in orbital implants: a systematic review.

PURPOSE: Various materials have been proposed for reconstructing orbital fractures. The materials used must meet certain criteria to ensure their suitability for restoring the structure and function of the organ. These criteria include biocompatibility, ease of application, non-toxicity, hypo-allergenicity, and non-carcinogenicity. In this study, we systematically reviewed the studies regarding the biomaterials in orbital implants and their clinical application. METHODS: A comprehensive search across various databases, including PubMed, Scopus, EMBASE, Cochrane Library, and Web of Science, was conducted until April 10th, 2023. After retrieving the search results and eliminating duplicates, final studies were included after screening through defined criteria. Human and animal studies assessing the clinical application of biomaterials in orbital implants were included. The quality of the case series and controlled intervention studies were evaluated using the NIH tool, and for animal studies, the risk of bias was assessed using SYRCLE's tool. RESULTS: Seventeen studies were included according to defined criteria. These studies aimed to explore the clinical application of biomaterials and examine the associated complications in orbital implants. CONCLUSION: We found that using biomaterials did not result in elevated intraocular pressure (IOP). However, we did observe certain complications, with infection, residual diplopia, and enophthalmos being the most frequently reported issues.

Factors affecting anophthalmic socket reconstruction outcomes using autologous oral mucosal graft.

BACKGROUND: Limited studies have reported surgical outcomes that are defined by strict criteria following grade 2 or 3 socket reconstruction using an oral mucosal graft (OMG). We aimed to determine factors influencing surgical outcomes of anophthalmic socket reconstruction using OMG in patients with grade 2 or 3 socket contractures. METHODS: Thirty-seven patients who underwent socket reconstruction with autologous OMG between January 2007 and December 2017 were retrospectively analyzed. The successful outcome was defined as an eye prosthesis wearing without experiencing displacement and the absence of any re-operations or additional surgeries following socket reconstruction. Factors affecting surgical outcomes were identified using multivariate analysis. RESULTS: A total of 15 male and 22 female patients (mean age: 40.2 ± 17.2 years) were included. The median duration of socket contracture was 21.5 years. Grade 2 and 3 socket contractures, based on Tawfik's classification, were reported in 20 and 17 patients, respectively. Twenty-eight and eight patients underwent socket reconstruction using OMG alone and OMG combined with a hard palate graft, respectively. The success rates of grades 2 and 3 socket contracture reconstruction were 80.0% and 52.9%, respectively. Multivariate analysis demonstrated that only grade 3 contractures were predictive of worse outcomes. At the final visit (mean follow-up: 6.3 years), 34 patients (91.9%) could wear their eye prostheses. CONCLUSIONS: Socket reconstruction using autologous OMG can provide acceptable results in grade 2 and 3 contractures; however, satisfactory results were more significantly reported in grade 2 than in grade 3 contractures.

Surgical management of orbital implant exposures after evisceration or enucleation: Retrospective study - Limoges University Hospital.

INTRODUCTION: Implant exposure is the most frequent complication after evisceration or enucleation, and multiple surgical techniques for the management of orbital implant exposure. The goal of our study is to investigate the success rate and risk factors for failure of various surgical procedures. METHODS: This was a retrospective study performed at the University Hospital of Limoges. We collected data from the files of every patient operated on for implant exposure between January 2005 and December 2020. The main criterion was the percentage of success for each procedure. Secondary objectives were to identify risk factors for failure of Müller's muscle flaps and to determine the incidence of post-enucleation socket syndrome depending on whether the orbital implant was maintained. RESULTS: Fifty-one patients were included: 26 patients who underwent Müller's muscle flap, 16 dermis-fat graft, 3 conjunctival flap, 2 amniotic membrane graft, 1 temporalis fascia graft, 1 buccal mucosa graft, 1 implant rotation, and 1 implant exchange. The dermis-fat grafts were more successful (87.5%) than the Müller's muscle flaps (52.2%) (P=0.0213). The study highlighted the importance of good vascularization of the implant (OR=32.00, P-value=0.0245) for the success of Müller's muscle flaps, and we found no statistically significant difference between the patients who maintained their implants and those who did not (P=0.3865) with regard to the incidence of post-enucleation socket syndrome. CONCLUSION: Müller's muscle flap may remain a reasonable option in the management of medium-sized implant exposures of well-vascularized implants confirmed on MRI in patients with no systemic healing disorders. Dermis-fat graft remains the option of choice in other cases, especially in large exposures or complicated orbits.

Does Integration of Technology and Customization of Implants Produce Better Outcomes in Post-Traumatic Orbital Reconstruction? A Systematic Review and Meta-Analysis.

PURPOSE: This review aims to compare and evaluate the outcomes achieved by integrating technological aids and the influence of different implant designs in the reconstruction of post-traumatic orbital defects. METHODS: Electronic searches of the MEDLINE, Embase, Cochrane Library, and Google Scholar databases until March 2023 were conducted. Clinical controlled trials, observational studies, cohort studies, and retrospective studies were identified and included. The predictor variables were the integration of technological aids namely, computer-assisted surgical planning, mirror image overlay, and intraoperative navigation with the utilization of different orbital implant designs (standard orbital meshes, preformed implants, prebent implants, and patient-specific implant [PSI]) during post-traumatic orbital reconstruction. The primary outcome variables were orbital volume, diplopia, and enophthalmos. Weighted or mean difference and risk ratios at 95% confidence intervals were calculated, where P ＜ .05 was considered significant and a random effects model was adopted. RESULTS: This review included 7 studies with 560 participants. The results indicate that the difference in postoperative orbital volume between affected and nonaffected eye showed no statistically significant difference between PSI and prebent group (mean difference, -0.41 P = .28, I2 = 46%). PSI group resulted in diplopia 0.71-fold less than that of the standard orbital mesh group but was not statistically significant (P = .15). Standard orbital mesh group is 0.30 times at higher risk of developing enophthalmos as compared to PSI group (P = .010). The literature suggests PSIs are preferred for patients with large defects (Jaquiéry's III-IV), whereas prebent implants are equally effective as PSIs in patients with preserved infraorbital buttress and retrobulbar bulge. CONCLUSION: PSIs are associated with improved outcomes, especially for correcting enophthalmos. The data suggests the potential efficacy of prebent implants and PSIs in orbital volume corrections. There is a lack of randomized studies. This review should serve as a recommendation for further studies to contribute to the existing literature.

Standardized clinical evaluation of dry anophthalmic socket syndrome in a real-world approach.

PURPOSE: To assess which signs and eye prosthesis care habits are related to subjective discomfort in patients with dry anophthalmic socket syndrome (DASS), using standardized tools from daily practice. METHODS: 62 anophthalmic sockets were compared with their healthy fellow eye using the Standard Patient Evaluation of Eye Dryness (SPEED) score. The correlations between SPEED questionnaire and the prosthesis care, discharge characteristics score, conjunctival inflammation score, meibomian gland dysfunction (MGD) scores and Schirmer I test were studied. RESULT: The anophthalmic sockets group achieved a higher SPEED test score (p < 0.01), discharge score (p < 0.01), conjunctival inflammation score (p < 0.01), MGD scores (p < 0.01) and lower Schirmer I test (p < 0.01) compared with their fellow, healthy eye. Patients with a prosthesis replacement of one year or less, those with a current fit time of one year or less and those with a cleaning frequency above one month reported better SPEED, (p < 0.01), conjunctiva inflammation (p < 0.01) and MGD scores (p < 0.01). CONCLUSION: Most anophthalmic patients suffer mild to severe DASS, which seems related to discharge, conjunctival inflammation and MGD. Moreover, certain practices related to the care of the prosthesis such as replacing with a frequency lower than yearly, current fitting time inferior to one year and a removing and cleaning regime above one month, were related to a lower discomfort sensation, conjunctival inflammation and MGD. Clinicians should consider the DASS when facing patients with anophthalmic socket and discomfort symptoms.

One-stage Intraconal Volume Modification for Exposed and Nonexposed Ball Implants.

PURPOSE: To assess long-term outcomes and reinterventions for exposed and nonexposed intraconal orbital implants after single-stage socket revisional surgery. METHODS: Retrospective case-note review of patients with exposed or nonexposed orbital ball implants, who underwent a single-stage ball exchange (Group I) or ball removal with dermis-fat graft (Group II); Group I was subdivided as having either exposed (A) or nonexposed (B) implants. Outcomes were compared with similar cohorts undergoing multistage surgery. RESULTS: Of 172 patients (54% male), 153 (89%) underwent ball exchange (Group I) and 19 (11%) had dermis-fat graft (Group II). With a mean follow up of 7.8 years, Group I patients without ball exposure (Group IB) had a slightly higher rate of reintervention for persistent volume deficit (21% vs. 9%; p = 0.163) and implant migration (6% vs. 0%; p = 0.091), while Group IA patients-having surgery for exposed implants-had more reexposures (7% vs. 3%; p = 0.270). Single-stage and 2-stage surgery had similar reintervention rates, with the exception of a trend toward fewer volume enhancements for those with nonexposed implants (17% vs. 30%; p = 0.380), and a shorter time to (re)exposure for exposed implants after 2-stage procedures (mean 0.33 vs. 3.5 years; p = 0.571). Group II patients required further volume enhancement in 32% of 1-stage procedures, and one patient needed graft removal. CONCLUSION: Single-stage volume modification is effective and the results are comparable to staged surgery for either exposed or nonexposed implants. Most patients report a stable prosthesis and satisfactory cosmesis, after a faster rehabilitation.

Customized orbital implant versus 3D preformed titanium mesh for orbital fracture repair: A retrospective comparative analysis of orbital reconstruction accuracy.

This study aimed to compare the accuracy of inferomedial orbital fracture restoration using customized orbital implant versus 3D preformed titanium mesh. Patients were divided into two groups. Group 1 underwent surgery with customized orbital implants and intraoperative navigation, while group 2 was treated using 3D preformed titanium meshes with preoperative virtual surgical planning (VSP) and intraoperative navigation. Reconstruction accuracy was assessed by: (1) comparing the postoperative reconstruction mesh position with the preoperative VSP; and (2) measuring the difference between the reconstructed and unaffected orbital volume. Pre- and postoperative diplopia and enophthalmos were also evaluated. Fifty-two patients were enrolled (25 in group 1 vs 27 in group 2). The mean difference between final plate position and ideal digital plan was 0.62 mm (SD = 0.235) in group 1 and 0.69 mm (SD = 0.246) in group 2, with no statistical difference between the groups (p = 0.282). The mean volume differences between the reconstructed and unaffected orbits were 0.95 ml and 1.02 ml in group 1 and group 2, respectively, with no significant difference between the groups (p = 0.860). Overall clinical improvements, as well as complications, were similar. 3D preformed titanium meshes can reconstruct inferomedial fractures with the same accuracy as customized implants. Therefore, in clinical practice, it is recommended to use 3D preformed meshes for this type of fracture due to their excellent results and the potential for reducing time and costs.

Socket outcomes following enucleation for uveal melanoma: post enucleation socket syndrome can be challenging.

PURPOSE: To evaluate socket outcomes of enucleation for uveal melanoma. METHODS: This study was a retrospective chart review conducted in December 2022 of all patients who underwent enucleation surgery for uveal melanoma between 2010 and 2015 in the Royal Victoria Eye and Ear Hospital, to evaluate socket outcomes including completion of revision surgery, type of surgery, and completion of multiple revision surgeries, and potential associations. RESULTS: Between June 2010 and December 2015, 72 patients underwent enucleation for uveal melanoma in the ocular oncology service, including 25 females and 47 males, mean age 65, range 11-91 years old. There were 68 primary enucleations and 4 secondary enucleations. Complete follow-up data was available for mean 4 years, range 1-11 years. Fourteen patients underwent further surgery, including one exenteration for local recurrence. Oculoplastic surgery (n = 6, 8%), implant exposure repair (n = 3, 6%), and orbit volume expanding surgery (n = 4, 6%) were also performed. Eight patients (11%) underwent one further surgery and five patients (7%) underwent a series of procedures. There was a significant association with younger age at enucleation (age <65) with undergoing further surgery (p = 0.03, Fisher's Exact Test (FET)), and also an association of younger age with undergoing multiple further surgeries (p = 0.02, FET). There was no association found with other predictor variables, including primary versus secondary enucleation status. Most patients (75%) with PESS underwent more than one surgery. CONCLUSION: Post enucleation surgery 82% of patients did not undergo further surgery, but younger patients were more likely to undergo anophthalmic socket revision or oculoplastic surgery. Management of post enucleation socket syndrome was challenging and usually involved a series of procedures.

Infection of a Nylon Foil Orbital Implant Due to Fusarium brachygibbosum and Lomentospora prolificans After Intranasal Methamphetamine Use.

The authors describe a case of nylon foil implant infection caused by Fusarium brachygibbosum , and Lomentospora prolificans following medial orbital wall fracture repair in the setting of postoperative nasal methamphetamine use. A 61-year-old male presented with OS pain and swelling after a physical assault on his face. A CT of maxillofacial bones without contrast showed a moderately comminuted fracture of the medial wall of the left orbit with depression of fracture fragments into the left ethmoid air cells. Six days after repair of the medial wall fracture, the patient returned with a new onset headache, OS pain, and swelling to the left medial canthal area. He reported snorting methamphetamine approximately 48 hours before his current presentation. CT imaging showed fat stranding and soft tissue density in the extraconal space adjacent to the left medial rectus muscle and chronic fracture deformity of lamina papyracea with approximately 4 mm of medial displacement of the fracture fragments. The patient showed little clinical improvement after 48 hours of intravenous antibiotics, which led to the removal of the nylon foil implant by a left orbitotomy. Intraoperative tissue cultures grew coagulase-negative Staphylococcus , F. brachygibbosum , and Lomentospora (Scedosporium) prolificans . The patient was subsequently transitioned to oral clindamycin 600 mg three times daily and voriconazole 200 mg two times daily. To the authors' knowledge, this is the first case report to document an association between snorted methamphetamine and a fungal infection of an orbital implant.

Long-Term Outcome of Staged Socket Surgery for Acquired Anophthalmos.

PURPOSE: To evaluate long-term outcomes of staged volume rehabilitation for acquired anophthalmos. METHODS: Case-note review of patients who had preceding i) eye removal without implant, ii) eye removal with an intraconal implant, but ball-related problems, or iii) removal of exposed implant. Secondary interventions were a) a first-time ball implant, b) dermis-fat graft, c) ball repositioning, d) ball replacement after prior removal, or e) orbital floor implantation. RESULTS: Secondary volume-augmenting surgery was performed in 175 sockets at a mean age of 42.7 years (range 2-91), with 62% secondary ball implants, 3% dermis-fat grafts, 6% ball repositioning, 19% ball replacement after prior removal for exposure, and 10% having orbital floor implantation. After this surgery, further volume enhancement was required in 21% of sockets, this being 40% for spheres ≤18 mm diameter, in contrast to 6% for those ≥20 mm ( p < 0.001). Exposure or malposition of the secondary implant occurred in 8% (12/151) and was unrelated to implant type, size, wrapping, or prior irradiation. Tertiary surgery addressed lining deficiency (18%) or eyelid malposition (25%). Overall, 92/175 (53%) had tertiary surgery to improve cosmesis and comfort, with 49% (36/92) being related to small implants. At a mean follow-up of 9.1 years, 82% of sockets had adequate volume, 79% had excellent lining, and 93% were comfortable. Prosthetic fit was satisfactory in 96% of cases, and 97% reported improved cosmesis. CONCLUSION: Over half of the sockets having planned 2-stage volume enhancement may need further procedures, especially after small-volume secondary implants, but, with meticulous surgery, reasonable long-term results can be achieved with few complications.

Surgical outcomes of unwrapped acrylic orbital implants: A review of 192 patients.

PURPOSE: The purpose of this study is to report the results in a series of acrylic orbital implant placements without the use of wrapping material. METHODS: We retrospectively reviewed the records of the patients who underwent enucleation with acrylic orbital implant insertion without scleral wrapping at the Department of Ophthalmology, Poznan University of Medical Sciences, Poland, between 2013 and 2020. RESULTS: There were 192 patients: 102 women and 90 men, mean age: 60 years (range: 13-90 years). In the majority of cases, the reason for enucleation was uveal melanoma (148 patients-77.1%), followed by secondary glaucoma in 22 patients (11.5%) and painful, phthisical eye in 16 (8.3%). The median follow-up was 23 months (range: 1-96 months). The stability of the implants was satisfactory in the majority of cases, and there were no cases of implant migration identified during the study period. We noted a total of 4 (2%) implant exposures. Other postoperative complaints included eyelid malposition-21 patients (11%), Tenon's capsule thinning (15 patients-7.8%) and post-enucleation eye socket syndrome (PEES)-7 patients (3.6%). The rate of postoperative complications was associated only with a history of previous ocular surgery (P=0.006). CONCLUSIONS: The stability and functional outcomes of unwrapped acrylic orbital implants in this group of patients were satisfactory during the follow-up period.

Quality of life and psychological evaluation of patients after anaplastology.

A comprehensive questionnaire with 43 questions was designed to evaluate quality of life, based on rehabilitation with a facial prosthesis. Each patient's psychological situation was assessed using the validated questionnaire and associated scales. Different patient groups were compared with each other in terms of questionnaire scores and general data. In total, 76 patients with a prosthesis of the orbit, nose, or ear, or a combination thereof, were included. There was a highly significant difference in overall satisfaction with defect reconstruction via a prosthesis of the ear compared with the orbit and nose (F(3) = 6.511, p = 0.001). Patients with congenital defects showed a significantly higher level of general satisfaction compared with patients with acquired defects (F(2) = 5.795, p = 0.001). Patients who returned to work were significantly more satisfied with their quality of life (T(57) = 2.626, p = 0.011). With regard to improvements to the state-of-the-art prostheses, the majority of patients suggested better retention, more durable colors, make-up possibilities, less noticeable margins, softer materials, and a movable orbital prosthesis. Within the limitations of the study it seems that facial epitheses improved mental wellbeing and increased quality of life among patients with facial defects. Multiple factors, such as type of facial defect, location of residence, and education can have a potential influence on the quality of life of affected patients. However, further studies are needed, since the psychological and social challenges remain.

Individualized implants using point-of-care printed models in the treatment of orbital blowout fractures.

OBJECTIVE: This case series aims to highlight the digital workflow used by our institution to treat orbital fractures by creating individualized implants using point-of-care, 3-dimensional (3D) printed models. STUDY DESIGN: The study population comprised consecutive patients who presented to John Peter Smith Hospital with isolated orbital floor and/or medial wall fractures from October 2020 to December 2020. Patients treated within 14 days of their initial injury and with 3 months postoperative follow-up were included. Bilateral orbit fractures were excluded because an intact contralateral orbit is needed for 3D modeling. RESULTS: A total of 7 consecutive patients were included. The orbital floor was involved in 6 of the fractures, whereas 1 fracture involved the medial wall. All patients with preoperative diplopia, enophthalmos, or both had resolution by the 3-month postoperative follow-up appointment. Postoperatively, there were no complications in all patients included. CONCLUSIONS: The point-of-care digital workflow presented allows for the efficient production of individualized orbital implants. This method may produce a midface model in hours that can be used to pre-mold an orbital implant to the mirrored, unaffected orbit.

[Embedded 3D printing of porous silicon orbital implants and its surface modification].

OBJECTIVE: To prepare customized porous silicone orbital implants using embedded 3D printing and assess the effect of surface modification on the properties of the implants. METHODS: The transparency, fluidity and rheological properties of the supporting media were tested to determine the optimal printing parameters of silicone. The morphological changes of silicone after modification were analyzed by scanning electron microscopy, and the hydrophilicity and hydrophobicity of silicone surface were evaluated by measuring the water contact angle. The compression modulus of porous silicone was measured using compression test. Porcine aortic endothelial cells (PAOECs) were co-cultured with porous silicone scaffolds for 1, 3 and 5 days to test the biocompatibility of silicone. The local inflammatory response to subcutaneous porous silicone implants was evaluated in rats. RESULTS: The optimal printing parameters of silicone orbital implants were determined as the following: supporting medium 4% (mass ratio), printing pressure 1.0 bar and printing speed 6 mm/s. Scanning electron microscopy showed that the silicone surface was successfully modified with polydopamine and collagen, which significantly improved hydrophilicity of the silicone surface (P < 0.05) without causing significant changes in the compression modulus (P > 0.05). The modified porous silicone scaffold had no obvious cytotoxicity and obviously promoted adhesion and proliferation of PAOECs (P < 0.05). In rats bearing the subcutaneous implants, no obvious inflammation was observed in the local tissue. CONCLUSION: Poprous silicone orbital implants with uniform pores can be prepared using embedded 3D printing technology, and surface modification obviously improves hydrophilicity and biocompatibility of the silicone implants for potential clinical application.

An Ex Vivo Pilot Study to Assess the Feasibility of 3D Printing of Orbital Implants in Horses.

Severe ophthalmic conditions such as trauma, uveitis, corneal damage, or neoplasia can lead to eye removal surgery. Poor cosmetic appearance resulting from the sunken orbit ensues. The aim of this study was to demonstrate the feasibility of manufacturing a custom-made 3D-printed orbital implant made of biocompatible material for the enucleated horse and usable in conjunction to a corneoscleral shell. Blender, a 3D-image software, was used for prototype design. Twelve cadaver heads of adult Warmbloods were collected from the slaughterhouse. On each head, one eye was removed via a modified transconjunctival enucleation while the contralateral eye was kept intact as control. Ocular measurements were collected on each enucleated eye with the help of a caliper and used for prototype sizing. Twelve custom-made biocompatible porous prototypes were 3D-printed in BioMed Clear resin using the stereolithography technique. Each implant was fixated into the corresponding orbit, within the Tenon capsule and conjunctiva. Heads were frozen and thin slices were then cut in the transverse plane. A scoring system based on four criteria (space for ocular prosthesis, soft-tissue-coverage, symmetry to the septum, and horizontal symmetry), ranging from A (proper fixation) to C (poor fixation), was developed to evaluate implantation. The prototypes reached our expectations: 75% of the heads received an A score, and 25% a B score. Each implant cost approximately 7.30€ and took 5 hours for 3D-printing. The production of an economically accessible orbital implant made of biocompatible porous material was successful. Further studies will help determine if the present prototype is usable in vivo.

Treatment of orbital fractures - a critical analysis of ophthalmic outcomes and scenarios for re-intervention.

BACKGROUND: Malplaced implants in orbital reconstruction may lead to serious complications and necessitate re-intervention. The aim of this study was to describe outcomes, complications and scenarios of re-intervention in a historical case series of orbital fractures treated with free-hand orbital wall reconstruction. The main hypothesis was that early re-interventions are mainly because of malplaced implants in the posterior orbit. METHODS: Retrospective review of 90 patients with facial fractures involving the orbit, reconstructed with radiopaque orbital wall implants, from 2011 to 2016. Data were obtained from medical records and computed tomography images. Recorded parameters were fracture type, ocular injury, ocular motility, diplopia, eye position, complications and re-interventions. Secondary reconstructions because of enophthalmos were volumetrically evaluated. RESULTS: Early complications requiring re-intervention within 1 month were seen in 12 (13%) patients, where all except two were because of malplaced implants. The implant incongruence was without exception found in the posterior orbit. Late complications consisted of four (4%) cases of ectropion and five (5%) cases of entropion that needed corrective surgery. The majority of the patients with eye-lid complications had undergone repeated surgeries. Secondary orbital surgeries were performed in nine (10%) patients. Five of these patients had secondary reconstruction for enophthalmos and associated diplopia. None of these patients became completely free from either enophthalmos or diplopia after the secondary surgery. CONCLUSION: Re-intervention after orbital reconstruction is mainly related to malplaced implants in the posterior orbit. Incomplete results in patients requiring secondary surgery for enophthalmos infer the importance of accurate restoration of the orbit at primary surgery. Abstract presented at: Swedish surgery Week 2021 and SCAPLAS 2022.