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.

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.

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.

Foldable capsular vitreous body indications, complications, and outcomes: a systematic review.

PURPOSE: Foldable capsular vitreous body (FCVB) is an emerging vitreous substitute that has been recently introduced to treat various advanced vitreoretinal conditions including severe ocular trauma, complicated retinal detachment (RD), and proliferative vitreoretinopathy. METHODS: Review protocol was prospectively registered at PROSPERO (CRD42022342310). A systematic literature search using PubMed, Ovid MEDLINE, and Google Scholar for articles published until May 2022 was performed. The search included the following keywords: foldable capsular vitreous body, FCVB, artificial vitreous substitutes, and artificial vitreous implants. Outcomes included indications of FCVB, anatomical success rates, postoperative intraocular pressure (IOP), best-corrected visual acuity (BCVA), and complications. RESULTS: A total of 17 studies that utilized FCVB up to May 2022 were included. FCVB was used intraocularly as a tamponade or extraocularly as a macular/scleral buckle for various retinal conditions including severe ocular trauma, simple and complex RD, silicone oil-dependent eyes, and highly myopic eyes with foveoschisis. FCVB was reported to be successfully implanted in the vitreous cavity of all patients. Final retinal reattachment rate ranged from 30 to 100%. Postoperative IOP improved or was maintained in most eyes, with low postoperative complication rates. Improvement in BCVA ranged from 0 to 100% of subjects. CONCLUSION: Indications of FCVB implantation have recently widened to include multiple advanced ocular conditions such as complex RD, but also include simpler conditions as uncomplicated RD. FCVB implantation showed good visual and anatomical outcomes, few IOP fluctuations, and a good safety profile. Larger comparative studies are required to further evaluate FCVB implantation.

Polyester 5-0 suture for porous implant placement after retinoblastoma enucleation: analysis of 120 sockets.

BACKGROUND: Techniques used to suture the rectus muscle to the implant can influence the implant-related complications which is still a major problem following retinoblastoma enucleation. The goals of this work were to report the efficacy among patients with retinoblastoma who underwent enucleation followed by porous implant placement with the rectus muscles sutured with 5-0 polyester suture. METHODS: This was a retrospective study of consecutive patients with retinoblastoma who underwent primary enucleation and porous implant placement with the rectus muscles tagged and sutured to the implant with polyester 5-0 suture. All the patients were followed up for a minimum of 2 years. The main outcome measure was implant exposure. The secondary efficacy measures were other implant-related complications. RESULTS: Between May 2016 and December 2018, a total of 120 patients (120 eyes) underwent primary enucleation and porous implant placement were included. Postoperatively, 10/120 (8.3%) eyes developed exposure or conjunctival granuloma. Exposure was the most common postoperative complication (7/10, 70.0%). There were no cases of implant extrusion, migration, or infection. CONCLUSIONS: Polyester 5-0 sutures are successful in patients with retinoblastoma who underwent enucleation followed by porous implant placement. Complications are minimal. Polyester 5-0 sutures were not associated with unacceptable complications in this pediatric population.

The Scleral Cap Technique for Porous and Nonporous Orbital Implants.

PURPOSE: To describe the results and potential benefit of a banked homologous donor scleral cap over the anterior surface of polyglactin 910 mesh-wrapped porous and nonporous orbital implants during enucleation and secondary orbital implant surgery. METHODS: This is a single center, retrospective, clinical case series of 83 patients who received a polyglactin 910 mesh (Vicryl knitted mesh, undyed, Ethicon, Sommerville, New Jersey, USA) wrapped bioceramic or polymethylmethacrylate orbital implant (sphere or mounded) following enucleation and secondary orbital implant surgery by one surgeon over a 10-year period. A homologous donor scleral cap (approximately 1.5 × 1.5 cm diameter) was also placed over the anterior mesh-wrapped implant surface as an additional barrier. A minimum of 1-year follow up was required to be included in the study. The author analyzed patient demographics, type of surgery, implant type, implant size, follow-up duration, and presence or absence of implant exposure. The data from patients with greater than 1-year follow up are detailed in this report. RESULTS: The author identified 100 patients in his case files that had a scleral cap put in place over their implant. Seventeen patients were either lost to follow up or did not have at least a 1-year follow up, leaving 83 patients (44 enucleations, 39 secondary implants) that were followed for 12 to 120 months (average 60.5 months). There were no cases of implant exposure identified in either group of patients during this time period. CONCLUSIONS: Implant exposure can occur anytime post implant placement with a porous or nonporous orbital implant. This review suggests that a homologous donor scleral cap (approximately 1.5 × 1.5 cm diameter) over the polyglactin 910 mesh-wrapped implant surface may help prevent implant exposure. Patients with porous and nonporous orbital implants should be followed on a long-term basis as exposure can occur at anytime postsurgery, even several years later.

Novel use of an autologous scleral button graft to close the anterior defect in evisceration surgery.

PURPOSE: To present an alternative evisceration technique with long-term follow-up data. This technique involves the insertion of an acrylic implant into a modified scleral shell which is closed using an autologous scleral graft. METHODS: This was a retrospective analysis of eviscerations performed in a district-general hospital in the UK. All patients underwent conventional ocular evisceration after total keratectomy. A full thickness scleral graft is harvested from the posterior sclera, using an internal approach, with an 8 mm dermatological punch. An 18-20 mm acrylic implant is placed into the shell, and the scleral graft is used to close the anterior defect. Demographic characteristics, implant size and type, and cosmetic results from pictures of all patients were recorded. All patients were invited for a review to measure motility, eyelid height, patient recorded satisfaction and complications. RESULTS: Of the five patients identified, one had since died. The remaining four attended a review in person. The mean time between surgery and review was 48 months. The mean implant size was 19 mm. There were no cases of implant extrusion or infection. All four had a <1 mm asymmetry in measured eyelid height and ≥5 mm horizontal gaze motility. All patients self-reported "good" cosmesis. An independent assessment identified "mild asymmetry" in two cases and "moderate" in the other two. CONCLUSION: Evisceration with this novel autologous scleral graft technique restores volume in the anterior orbit with good cosmetic results, and with no cases of implant exposure reported in this small case series. This technique should be compared prospectively to established techniques.

Outcome of eviscerations and enucleations at a Swedish tertiary referral centre between 2008 and 2019: improved surgical management leading to reduced complication rate.

PURPOSE: The aim of this study was to investigate the results of all eviscerations and enucleations performed at the Department of Ophthalmology, Sahlgrenska University Hospital, during 2008-2019 and to compare them with previously collected data from 1999 to 2007. METHODS: This was a retrospective investigation using the medical records for all patients having had an evisceration or an enucleation at the Department of Ophthalmology, Sahlgrenska University Hospital, during the two defined periods of time. Main outcome measure was postoperative complications. RESULTS: During 1999-2007, 181 surgeries were performed, 100 with implants, and 28/100 exposed implants and 9/100 removed implants were recorded during follow-up. During 2008-2019, 250 operations were performed with 158 implants, and there were 3/158 exposed implants and 2/158 extruded implants. Two ruptures of the surgical wound without implant exposure were noted, and one implant was exchanged. The reduction of exposed implants between the two periods was statistically significant (p < .001, Chi-square test). In enucleations, the use of one kind of porous polyethylene implant in the recent study period replaced a multitude of implants in the earlier study period. In eviscerations, the major change between the two study periods was the introduction of the split sclera technique and smaller implant size. CONCLUSION: The change in surgical technique between the two periods led to a significant reduction in implant-related complications.

Antimicrobial-eluting cement orbital implant: a case report of staged enucleation for infectious panophthalmitis with extraocular extension.

There are various orbital implant options following enucleation. In cases of severe infection, such as panophthalmitis with extraocular extension, it is reasonable to consider a two-staged approach to decrease the risk of infectious complications. One option, illustrated by this case, is enucleation with insertion of an antimicrobial-eluting cement implant, followed by a secondary procedure to exchange the cement with a permanent orbital implant. We report on a patient with clinical, ultrasound, and radiographical findings consistent with infectious panophthalmitis with extra-scleral extension. Intolerable pain and progressive orbital involvement in a blind eye were the indications for enucleation. To reduce the risk of persistent infection, a gentamycin-eluting cement implant (Palacos® R + G as an intraorbital implant) was utilized in the initial procedure. Two months later, the cement implant was removed, and a scleral-wrapped porous implant was placed into a quiet socket without signs of inflammation or infection. In the setting of severe infection, a two-staged procedure utilizing an antimicrobial-eluting implant can be considered.

Acellular cadaveric dermal matrix grafts for orbital wall reconstruction in patients with sinonasal malignancies.

PURPOSE: To describe the utilization of acellular cadaveric dermal matrix (ACDM) in patients undergoing orbital wall reconstruction after orbital preservation surgery for sinonasal malignancy. METHODS: Retrospective case series of seven patients with sinonasal malignancy who had orbital reconstruction with ACDM implants from January 2012 to August 2020. Orbital preservation was performed in all patients with tumor extension up to and including periorbital. The main outcome measures were implant exposure, orbital infection, diplopia in primary gaze, enophthalmos, and eyelid malposition. RESULTS: Patients ranged 37-78 years old (median: 66 years) and included 4 females and 3 males. The median follow-up time was 9 months (range 6-43 months) from the date of surgery. Squamous cell carcinoma comprised the majority of tumors with all patients needing medial wall reconstruction. Three patients received postoperative radiation therapy. No patients had any implant exposure, orbital infection, enophthalmos, or eyelid malposition. CONCLUSIONS: ACDM grafts can be used safely in orbital wall reconstruction in patients with sinonasal malignancies.

Single or double? A comparison of evisceration techniques.

PURPOSE: We compared the rates of implant exposure and extrusion after evisceration with single and double scleral closure techniques. METHODS: This retrospective cohort study included all patients who underwent evisceration with an implant insertion over the past 18 years at Tung Wah Eastern Hospital and Pamela Youde Nethersole Eastern Hospital. Clinical documents and operation records were reviewed. RESULTS: A total of 81 ethnic Chinese patients (44 male) who underwent evisceration with primary implant insertion were reviewed. 39 (48%) patients underwent the double scleral closure technique with an implant placed posterior to the posterior sclera, and 42 (52%) patients underwent the single scleral closure technique with an implant inserted in the intra-scleral cavity. The follow-up interval was 70 months. The surgical indications were endophthalmitis (35%), painful blind eye (23%), traumatic disfigured globe (22%) and phthisis bulbi (20%). Silicone was the most used implant material (69%). The patients who underwent double scleral closure had a larger size of the implant (19.7 vs 17.9 mm, p < 0.05). Both implant exposure (26% vs 3%, p < 0.05) and implant extrusion (26% vs 0%, p < 0.05) were more common in patients who underwent single scleral. CONCLUSIONS: Double scleral closure technique allows a larger implant, and it is associated with a lower rate of implant exposure and extrusion. The double scleral closure technique is a superior technique of choice in these patients with primary implant placement.

Post-enucleation socket syndrome-a novel pathophysiological definition.

BACKGROUND: The last definition of the post-enucleation socket syndrome (PESS) by Tyers and Collin-formulated almost 40 years ago in 1982-is predominantly based on the clinical characteristics and does not include the insights of newer studies into the pathophysiological mechanism of the PESS. METHODS: A systematic PubMed literature review regarding the pathophysiological mechanism of the PESS was performed, and results were comprised to give an overview of the current knowledge of the PESS including the exact pathophysiological mechanism. RESULTS: The primarily postulated pathophysiological mechanism of the PESS was the atrophy of orbital tissues, especially of fat, resulting in variable clinical findings. Newer studies using high-resolution computed tomography and magnetic resonance imaging or performing histopathological analyses found no orbital fat atrophy but rather a rotatory displacement of the orbital tissues from superior to posterior and from posterior to inferior together with the retraction of the extraocular muscles and a possible volume loss of the orbital implant by resorption if it is manufactured from hydroxyapatite. PESS results in a backward tilt of the superior fornix, a deep superior sulcus, a pseudo-ptosis, a lower eyelid elongation and laxity, a shallower inferior fornix, as well as enophthalmos and may lead to an inability of wearing ocular prostheses. CONCLUSIONS: A novel and comprehensive definition of the PESS is proposed: PESS is a multifactorial and variable syndrome caused by a rotatory displacement of orbital contents together with the retraction of the extraocular muscles and possible resorption of the orbital implant if it is manufactured from hydroxyapatite.

Pitfalls of Surgeon-Engineer Communication and the Effect of In-House Engineer Training During Digital Planning of Patient-Specific Implants for Orbital Reconstruction.

PURPOSE: The use of patient-specific implants for reconstruction of complex orbital floor defects is increasing and requires communication with an industry partner, which warrants investigation. Therefore, the aim of this study was to evaluate the effects of in-house training of engineers on such communication as well as to identify frequent sources of problems and their solutions for improvement of the implant-planning workflow. METHODS: We conducted a retrospective cross-sectional study and enrolled a sample of patients who had undergone orbital reconstruction with patient-specific implants between 2017 and 2020. The predictor variables were in-house training (additional training completed in hospital or not) and implant complexity (complex [multiwalled implants] vs less complex [isolated orbital floor reconstructions]). The outcome variables were duration of communication, message length, and need for synchronous communication or modifications to the original design. Descriptive, univariate, and multivariate statistics were computed, and statistical significance was set at a P value of < 0.05. RESULTS: This study included the data of 66 patients (48 men and 18 women, average age: 42.27 years). The complexity of the implant statistically significantly increased the duration of the communication (8.76 vs 16.03 days; P = .004). In 72.73%, the initial design had to be changed. Engineers trained in house required less communication to plan less-complex implants and generally needed fewer corrections to the original design (P = .020 and P = .036, respectively). Problems during planning were observed in 25.76% of the cases, with an insufficient diagnostic 3-dimensional data set being the most common (15.15%). CONCLUSIONS: In-house training of engineers is time-saving while planning the workflow for patient-specific implants, especially in less-complex cases, given that design changes are not needed often. The high rate of data sets that were insufficient for planning patient-specific implants suggests that diagnostic 3-dimensional data sets should already meet the requirements for such planning.

Do Patient-Specific Implants Decrease Complications and Increase Orbital Volume Reconstruction Accuracy in Primary Orbital Fracture Reconstruction?

PURPOSE: Patient-specific titanium implants are increasingly used in orbital trauma as a means of achieving improved surgical outcomes as well as decreasing postoperative complications; however, the data to support their use remain limited. The purpose of this study is to compare the complication rates and accuracy of orbital reconstruction using preformed titanium mesh implants and patient-specific implants. METHODS: The authors conducted a retrospective cohort study consisting of patients with orbital floor and/or medial wall fractures treated by reconstruction with either preformed or patient-specific implants from August 1, 2015 to December 31, 2020. The primary predictor variable was the implant type. Outcome variables were the percent volume difference between the reconstructed and uninjured orbital volume and complications. Statistical analysis was performed using Fisher exact test and Wilcoxon rank-sum test. RESULTS: Of the 85 patients in the study, 73% were male and the average age was 38.7 ± 16.6 years. Sixty-one patients (72%) were treated with preformed implants and 24 (28%) with patient-specific implants. Complications occurred in 8.3% of the patient-specific implant group and 26.2% of the preformed implant group (P = .08). Percent volume difference between the reconstructed and nontraumatized orbit was 4.2% and 6.8% in the patient-specific and preformed implant group, respectively (P = .03). CONCLUSIONS: Patient-specific implants improved orbital volume reconstruction accuracy but did not decrease complications when compared to preformed implants.

Wraparound nylon foil implant for isolated orbital floor fractures.

PURPOSE: There are a variety of implant materials available for orbital floor fracture repair. Implant selection is guided by surgeon experience, availability, and patient specific needs. The purpose of this study is to describe a "wraparound" technique for nylon foil implant placement for large, isolated floor fractures that provides excellent results with low incidence of enophthalmos or other complications. MATERIALS AND METHODS: A retrospective chart review from 2012 to 2020 was conducted in patients who underwent isolated orbital floor fracture repair with the use of the "wraparound" nylon foil implant. The surgical technique is described. Preoperative CT scans were assessed, and the patients were divided into groups based on the size of the floor fracture. Postoperative data was collected including Hertel measurements and complications related to the implant. RESULTS: There were eighty patients who underwent orbital floor fracture repair with the described technique and had adequate follow-up. There were 18 (22.5%) small-sized fractures, 32 (40%) medium-sized fractures, and 30 (37.5%) large-sized fractures in the study group. One patient (3.33%) in the large fracture group had clinically significant enophthalmos of 2 mm postoperatively. There were no other patients with clinically significant enophthalmos. There were no instances of any complications related to the implant, and no patients required implant removal. CONCLUSIONS: The "wraparound" technique for a nylon foil implant provides excellent results for isolated orbital floor fractures. It provides more support and stability than traditional nylon implants for larger fractures and has minimal complication rates.

Orbital Implants Receiving Food and Drug Administration Premarket Notification.

PURPOSE: This perspective explores the Food and Drug Administration (FDA) 510(k) program, occasionally referred to as premarket notification, which facilitates faster marketing of Class II medical devices, such as orbital implants by demonstrating "substantial equivalence" to previously approved devices. This allows for FDA clearance, rather than FDA approval of orbital implants via comparison to currently marketed implants rather than clinically proven safety standards. METHODS: Utilizing the FDA's publicly available 510(k) Premarket Notification database, we conducted a thorough search of FDA-cleared orbital implants dating back to the inception of the 510(k) process in 1976. RESULTS: We found that 29 orbital implants received 510(k) FDA clearance between 1987 and 2022. Four of the 29 implants were recalled. Only 9 of 29 implants had available data on their predicate or comparison devices; of these 9, 3 implants received clearance based on devices that were subsequently recalled. CONCLUSIONS: This investigation into premarket approval of orbital implants identifies a shortcoming in the FDA 510(k) approval process. Long-term implant-associated morbidity is difficult to predict during premarket analysis but is further complicated for 510(k) cleared implants since devices approved based on substantial equivalence to recalled devices may not be automatically recalled. Clinicians should be aware of the approval process for the devices they select, and review of the 510(k) process, especially as it applies to substantial equivalence to devices subsequently recalled is warranted.

Silicone Sphere Implant Extrusion From Orbital Granulomatosis With Polyangiitis: A Rare Complication in the Anophthalmic Socket.

Orbital implant extrusion is a known complication following evisceration and enucleation. In this case report, we present a 45-year-old woman who presented with a left silicone implant exposure and infection 2 years following evisceration with saddle nose on examination. CT of the maxillofacial bones without contrast showed bilateral soft tissue infiltration around the superior recti muscles, as well as a nasal septum perforation from extensive sinus disease. Left orbitotomy revealed a small fibrotic mass near the orbital roof. Biopsy and serology results were consistent with granulomatosis with polyangiitis.

Patient-specific Implants for Orbital Fractures: A Systematic Review.

PURPOSE: Orbital fractures are common facial fractures that can be challenging to repair and require careful attention to avoid unacceptable ophthalmic complications. Customized implants that are unique to an individual patient, or patient-specific implants (PSIs), have been increasingly used to repair orbital wall fractures. This systematic review summarizes the current evidence regarding custom-made orbital wall implants. METHODS: A keyword search of published literature from January 2010 to September 2021 was performed using Ovid MEDLINE, PubMed, and the Cochrane Library databases. Original articles that included more than 3 human subjects with an orbital fracture repaired with a PSI were included. The search results were reviewed, duplicates were removed and relevant articles were included for analysis. RESULTS: Fifteen articles meeting the inclusion criteria. The articles were categorized into 3 separate groups based on the method of PSI fabrication: manual molding of a PSI on a 3D-printed orbital model (53%), directly from a 3D printer (27%), or via a template fabricated from a 3D printer (20%). Three primary postoperative outcomes were assessed: rates of diplopia, enophthalmos, and orbital volume. Postoperative rates of diplopia and enophthalmos improved regardless of the PSI technique, and postoperative orbital volumes were reduced compared with their preoperative state. When PSIs were compared to conventional implants, patient outcomes were comparable. CONCLUSIONS: This review of existing PSI orbital implant literature highlights that while PSI can accurately and safely repair orbital fractures, patient outcomes are largely comparable to orbital fractures repaired by conventional methods, and PSI do not offer a definitive benefit over conventional implants.

Bioresorbable Implants in Reduction of Paediatric Zygomaticomaxillary Complex Fractures Concurrent With Internal Orbital Reconstruction.

PURPOSE: To evaluate the clinical effectiveness and safety of bioresorbable implants for treating paediatric zygomaticomaxillary complex (ZMC) fractures with concomitant orbital floor defects. METHODS: A retrospective review of paediatric patients who underwent ZMC repair with concomitant orbital floor fractures with bioresorbable implants in Shanghai Ninth People's Hospital from July 2015 to June 2019 was performed. The primary outcome measures included ocular motility, diplopia, enophthalmos, facial deformities, and restricted mouth opening, as well as complication rates. Pre- and post-operative computed tomography scans were obtained for clinical diagnosis and surgical effectiveness. RESULTS: Twenty two children were included in this study. Facial deformities were corrected in all 22 cases by surgical reconstruction postoperatively, and the average relative distance of Portals point-Zygomaxillare and Anteriornasalspine-Zygomaxillare were 1.3 ± 0.6mm ( P = 0.22) and 1.2 ± 0.5mm ( P = 0.19). The eye movement restored to normal in 13 patients. The mean amount of relative enophthalmos was 1.0 ± 0.4 mm ( P = 0.12). 12 cases had complete resolution of diplopia postoperatively at the extremes of the gaze, and 1 case presented persistent diplopia on the down gaze as before, but from level III to level I. Facial numbness was resolved completely in 6 cases, and 2 cases presented with persistent numbness but relieved significantly. The average Hounsfield units of RapidSorb plates and OrbFloor PI were 154 ± 5 and 99 ± 4 respectively on computed tomography image obtained 1 week postoperatively, which showed no obvious difference compared with 0.5 year postoperatively ( P > 0.1). Hounsfield units of implants gradually declined around 1 year postoperatively. Hounsfield units of RapidSorb plates (20 ± 1) were consistent with periorbital tissue during postoperative 2-year follow-up, and Hounsfield units of OrbFloor PI (19 ± 1) were consistent with periorbital tissue during postoperative 1.5-year follow-up. No patients had severe sequelae or implant related complications postoperatively. None of bone nonunion, malunion, infection or rejection occurred during the follow-up periods. CONCLUSIONS: Open reduction and internal fixation for the treatment of ZMC fracture have achieved significant improvement in functional and cosmetic outcomes postoperatively. Bioresorbable materials have been proved to be effective and safe in the treatment of children's ZMC and orbital wall fractures.