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PURPOSE: To describe our experience over 6 years using a new high-density polyethylene-based spherical integrated porous orbital implants (Oculfit). METHODS: This is an observational retrospective case series study analyzing all cases requiring Oculfit implants between February 2015 and September 2021. Clinical information regarding the population included, the characteristics of the implant, and the outcomes and complications during the follow-up were noted. The success of the implant was defined according to anatomical and functional parameters. RESULTS: The study analyzed 90 cases of anophthalmic patients. The main causes for enucleation or evisceration were ocular decompensations (36.7%) and neoplasms (27.8% uveal melanoma and 7.8% retinoblastoma). Anatomical success was identified in 63 (70.0%) cases, functional success in 79 (87.8%) and complete success (anatomical + functional) in 61 (67.7%) cases. Factors associated with the functional success were age and exposure of the primary orbital implant. Complications appeared in 11 (12.2%) cases, which were completely resolved without sequelae in 4 (4.4%). Orbital explant was required in 5 (5.6%) cases. CONCLUSION: In our experience, Oculfit can be considered a useful alternative among the currently available options for orbital implants and has a good efficacy/safety profile.

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OBJECTIVES: To retrospectively investigate clinical characterization and the long-term postoperative outcomes of retinoblastoma (RB) patients receiving enucleation with primary orbital implantation in early infancy (0-6 months old). METHODS: The clinical and follow-up data of 42 RB patients receiving enucleation with primary orbital implantation in early infancy at Beijing Tongren Hospital from December 2009 to January 2020 were analysed. The average follow-up time was 83 months. The patient group included 24 males and 18 females, 30 unilateral and 12 bilateral cases. A total of 44 eyes with 10 in stage D and 34 in stage E underwent 40 unilateral and 2 bilateral surgeries. 17 RB eyes received hydrogel and 27 RB eyes received hydroxyapatite implants. This study was performed by following the guideline of STROBE. RESULTS: Enucleation combined with primary orbital implantation promoted survival and was safe with few and minor complications such as increased secretion, upper eyelid ptosis, and sunken eye sockets which were not affected by stages, lateralities, or implant materials. 55-80% RB patients exhibited satisfactory appearance and obvious or moderate motility of orbital implants according to the evaluation by doctors and family members. Family members were likely more optimistic about the appearance and more pessimistic about motility of the orbital implantation than doctors did.The quality of life was high as indicated by PedsQL3.0 or PedsQL4.0 scores ( ≧ 90 for > 75% patients). It was not affected by the stages, laterality, and implant materials, nor affected by the appearance and motility of the implants. CONCLUSIONS: The outcomes of the combination of enucleation and primary orbital implantation for pertinent RB patients in early infancy are generally satisfactory with few and minor complications, high safety, appearance, and overall quality of life. Enucleation combined with primary orbital implantation in early infancy benefits pertinent RB patients in appearance, survival, and quality of life.

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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.

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OBJECTIVE: To reveal the long-term outcomes of enucleation and secondary orbital implantation surgeries employing nonabsorbable surgical mesh-wrapped acrylic orbital implants for various reasons. METHODS: A retrospective interventional study of 48 eyes that underwent primary or late primary enucleation and secondary orbital implantation using polyester mesh-wrapped acrylic orbital implants, between 2012 and 2021. Patient demographics, diagnosis, prior ophthalmic surgery, implant size, follow-up periods, and implant-associated complications were evaluated. RESULTS: The records of 36 patients who underwent primary or late primary enucleation and 12 who underwent secondary orbital implantation due to sphere extrusion were evaluated. Patients' mean age was 38.7 (range: 2-75) and the mean follow-up period was 48.3 months (range: 24-72 mo). Major causes for surgeries were trauma and malignancies (54.1% and 33.3%, respectively). No complications, such as conjunctival dehiscence, implant exposure or extrusion, contracted socket, or fornix insufficiency were observed in any patient during the long-term follow-up period postsurgeries. CONCLUSION: Using polyester mesh-wrapped acrylic orbital implants in enucleation and secondary orbital implantation surgeries proves to be a successful, safe, and cost-effective option.

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Orbital walls are one of the most common sites of midface fractures and account for ~40% of traumatic injuries in this region. These fractures are often associated with changes in the anatomy of the orbital cavity and frequently affect the orbital inferior wall, infraorbital groove and canal, and medial orbital wall, which leads to changes in its pattern and volume as well. Generally, the forces required for brake superior and lateral walls are greater than those required for thin medial and inferior walls. Disruption of any of these structures leads to the expansion of orbital volume that brings to the appearance of enophthalmos, diplopia, and impaired ocular mobility. The gold standard in the treatment of orbital wall fractures is surgical reconstruction, that includes fracture site exposure, freeing tissue prolapsed into the fracture site, and re-approximating the orbital wall support, usually with an orbital implant. It usually could be achieved by the usage of such as transconjunctival, subciliary, and coronal approaches and implementation of graft and reconstructive materials, including bones, cartilage, titanium, and resorbable mesh. Today, the gold standard in orbital floor reconstruction is the application of titanium mesh orbital plates. However, their implementation could be associated with a number of postoperative complications, such as mispositioning and orbital adherence syndrome. Orbital adherence syndrome is a poorly described and understood phenomenon and appears to occur after the use of large-pored titanium mesh for orbital reconstruction. It usually appears as limited eye movement that appears 1 to 2 weeks after reconstructive procedure. Prevention is possible through careful patient selection and the placement of a smooth interface medium in the initial surgery. The aim of the current study is to present the outcomes of orbital reconstruction done by both orbital mesh and customized ​​smooth-surfaced titanium orbital implants.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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PURPOSE: To evaluate the complications of anophthalmic socket in retinoblastoma patients at a tertiary centre in Malaysia. DESIGN: Retrospective study. METHODS: Patients who underwent enucleation for retinoblastoma were reviewed from 2004-2020. Details were recorded, including demographics, diagnosis, surgical techniques, implant types, additional therapies, and complications. RESULTS: Of 250 patients with retinoblastoma managed over the period, the anophthalmic sockets of 160 eyes who underwent enucleation were analysed. The mean age at enucleation was 2.03 years (26 days to 9.18 years). The follow-up periods after enucleation range from 5 days to 16.83 years. Porous polyethylene (Medpor) implants were used in 135 patients (84.4%), as were Bioceramic in 9, glass balls in 7, acrylic in 7, dermis fat grafts in 1, and silicone implants (Aurosphere) in 1. The overall complications in our study were 28.8%. Complications seen in the study included implant exposure (12.5%), shallow inferior fornix (10.6%), granuloma formation (3.1%), discharge (2.5%), implant migration (1.9%), ptosis (0.6%), and orbital dystopia (0.6%). Implant exposure is solely found in Medpor, more common in those with donor sclera caps, and exposure times range from 28 days to 11.42 years. The suturing of the Tenon and conjunctiva in separate layers significantly reduced the rate of implant exposure. Six out of seven radiation patients had shallow inferior fornixes. CONCLUSIONS: Long-term post-enucleation complications were not uncommon. Luckily, most had good outcomes, with a few needing surgical intervention. Meticulous suturing technique on the Tenon and conjunctival layer is essential to prevent implant exposure.

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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.

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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.

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