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.

Radiotherapy and Radiosurgery in the Management of Optic Nerve Sheath Meningiomas: An International Systematic Review and Meta-Analysis of Twenty Studies.

BACKGROUND: Optic nerve sheath meningiomas (ONMs) are often managed with radiotherapy (RT) with the goal of achieving radiographic local control (LC) and preventing deterioration of visual acuity (VA). We aimed to perform a systematic review and meta-analysis of outcomes for patients with ONM treated with RT. METHODS: The PICOS/PRISMA/MOOSE selection criteria were used to identify studies. Primary outcomes were stable or improved VA and radiographic LC at last follow-up. The secondary outcomes were incidences of radiation-induced retinopathy and xerophthalmia and stable or improved visual fields (VFs). Weighted random-effects meta-analyses using the DerSimonian and Laird methods were conducted to characterize effect sizes. Mixed-effects regression models were used to examine potential correlations between gross tumor volume (GTV) and outcomes. RESULTS: In total, 444 patients with ONM across 20 published studies were included. The estimated LC rate was 99.8% (95% confidence interval [CI], 98.3%-100%), and the estimated proportion of patients with stable or improved VA or VF was 89.7% (95% CI, 86.2%-92.4%) and 93.3% (95% CI, 89.5%-95.8%), respectively. Estimated incidences of radiation-induced retinopathy and xerophthalmia were 7.2% and 10.1%, respectively. GTV was significantly associated with VA (P = 0.014) with estimated VA rates of 96.4%, 91.4%, and 80.5% for GTVs of 2.0, 3.0, and 4.0 cm3, respectively. CONCLUSIONS: RT was well tolerated, with excellent LC achieved. Nearly 90% of patients noted either stability or improvement in VA and VF. Larger ONMs were associated with poorer VA.

Delayed Diagnosis of an Occult Wooden Orbital Foreign Body.

An orbital foreign body should be suspected in cases of penetrating orbital injury, but they are not typically seen with low-velocity trauma and no obvious penetrating injury. Wooden foreign bodies are difficult to distinguish from orbital fat on computed tomography (CT), and without a high degree of suspicion for a foreign body, techniques to distinguish wood in the orbit may not be utilized. The authors present here a case of an initially unrecognized wooden orbital foreign body in the setting of orbital trauma where the patient denied any possibility of a foreign body and no evidence of a penetrating injury. The diagnosis was eventually made with an interdisciplinary review of the imaging between the orbital service and radiology, and the foreign body was subsequently removed via orbitotomy. Surgeons should maintain a high index of suspicion when there is a question of a foreign body on imaging, and a low threshold to involve radiology colleagues in the diagnostic evaluation.

Man with a Swollen Eye: Nonspecific Orbital Inflammation in an Adult in the Emergency Department.

BACKGROUND: Nonspecific orbital inflammation (NSOI) is a rare idiopathic ocular pathology characterized by unilateral, painful orbital swelling without identifiable infectious or systemic disorders, which can be complicated by optic nerve compromise. CASE REPORT: A 50-year-old man presented to the Emergency Department with recurring, progressive painless left eye swelling, decreased visual acuity, and binocular diplopia in the absence of trauma, infection, or known malignancy. His physical examination was notable for left-sided decreased visual acuity, an afferent pupillary defect, severe left eye proptosis and chemosis, and restricted extraocular movements; his dilatated funduscopic examination was notable for ipsilateral retinal folds within the macula, concerning for a disruption between the sclera and the retina. Ocular examination of the right eye was unremarkable. Laboratory data were unrevealing. Gadolinium-enhanced magnetic resonance imaging showed marked thickening of the left extraocular muscles associated with proptosis, dense inflammatory infiltration of the orbital fat, and characteristics consistent with perineuritis. The patient was diagnosed with NSOI with optic neuritis and admitted for systemic steroid therapy; he was discharged on hospital day 2 after receiving high-dose intravenous (i.v.) methylprednisolone with significant improvement. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: NSOI is a rare and idiopathic ocular emergency, with clinical mimicry resembling a broad spectrum of systemic diseases such as malignancy, autoimmune diseases, endocrine disorders, and infection. Initial work-up for new-onset ocular proptosis should include comprehensive laboratory testing and gadolinium-enhanced magnetic resonance imaging. Timely evaluation by an ophthalmologist is crucial to assess for optic nerve involvement. Signs of optic nerve compromise include decreased visual acuity, afferent pupillary defect, or decreased color saturation. Patients with optic nerve compromise require admission for aggressive anti-inflammatory therapy with i.v. steroids in an attempt to reduce risk of long-term visual sequelae. Our case demonstrates a severe presentation of this disorder and exhibits remarkable visual recovery after 48 h of systemic i.v. steroid treatment.

Adenoid cystic carcinoma presenting with bilateral orbital extension from the soft palate.

Adenoid cystic carcinoma (ACC) is a rare neoplasm of secretory epithelium that most commonly occurs in the fifth and sixth decades of life. It is characterized by high recurrence rates and poor response to chemotherapy, In the orbit, ACC usually presents as a lacrimal gland mass. We describe the rare case of a 70-year-old woman who presented with pain during mastication and bilateral facial numbness in the cranial nerve V2 distribution. She was found to have adenoid cystic carcinoma involving the orbits bilaterally without lacrimal gland involvement and without a clear primary tumor. Imaging suggested that the tumor arose from the soft palate by extension along cranial nerves V2 and V3. The patient was treated with radiation therapy with some degree of radiographic improvement 27 months after diagnosis. This case emphasizes the importance of considering adenoid cystic carcinoma when evaluating orbital tumors sparing the lacrimal gland. We also suggest the possibility of an oropharyngeal source with anterograde intracranial extension in cases of putative primary orbital ACC without lacrimal gland involvement.

The Role of Biological Agents and Immunomodulators in Treatment Strategies for Thyroid Eye Disease: An Evidence-based Review.

Graves' Disease is an autoimmune disease where circulating antibodies bind to the thyrotropin receptors on the thyroid gland. These bound antibodies mimic thyroid stimulating hormone without the normal feedback from the anterior pituitary, causing hyperthyroidism and thyrotoxicosis. These antibodies also interact with orbital tissues and cause the characteristic orbital findings of thyroid eye disease (TED). It is not clearly understood why anatomically and physiologically distinct tissues like the thyroid gland and orbit are affected selectively, or why the orbital disease tends to be self-limited. Identifying and understanding these processes is critical to targeting therapy. In the active phase of the disease patients may experience orbital inflammation, eyelid and conjunctiva edema (chemosis), eyelid retraction, proptosis, ocular motility restriction, and optic nerve compression. Current treatment strategies for the ocular symptoms have been predominantly directed at symptomatic relief. More recently, investigators have concentrated their efforts to better understanding the underlying pathophysiologic processes to direct therapy at these processes. This review examines the current literature exploring a variety of newer therapeutic alternatives, including immunomodulative and suppressive agents, targeted at strategic points of the active-phase TED pathophysiological pathways. Specifically, biological agents including rituximab, adalimumab, intravenous immunoglobulin and others are reviewed with considerations for pathophysiology, extent of literature support, and adverse effects. [Full article available at http://rimed.org/rimedicaljournal-2016-06.asp, free with no login].

Lower eyelid involutional ectropion repair with lateral tarsal strip and internal retractor reattachment with full-thickness eyelid sutures.

PURPOSE: To report a novel surgical technique for lower eyelid involutional ectropion repair using a lateral tarsal strip and internal retractor reattachment procedure involving full-thickness eyelid sutures. METHODS: A retrospective review was performed of patients who underwent repair of involutional ectropion via lateral tarsal strip and internal retractor reattachment with full-thickness eyelid sutures by 1 surgeon. Patients having concomitant or previous eyelid surgical procedures were excluded. Collected data included patient demographics, surgical outcomes, and length of follow up. RESULTS: Forty-one lower eyelids of 31 patients with involutional ectropion underwent surgical repair. There were 17 men and 14 women in the age range of 69 to 92 years (mean age 82.2±5.9 years). Surgical sites included 22 right and 19 left lower eyelids. Follow up ranged from 1 to 48 months with an average of 5.9 months. Surgical success with anatomical correction of involutional ectropion was achieved in 39 of 41 eyelids (95.1%). There were no perioperative or postoperative complications. Two of 41 (4.9%) eyelids had recurrence of ectropion 7 and 18 months after the procedure. CONCLUSIONS: This procedure combining lateral tarsal strip with internal retractor reattachment involving full-thickness eyelid sutures effectively addresses horizontal eyelid laxity and tarsal instability, providing an effective technique to correct involutional ectropion of the lower eyelid.

Cellular neurothekeoma of the eyelid: a unique internal palpebral presentation.

A 50-year-old woman presented with a mass lesion of the inferolateral palpebral conjunctiva similar in appearance to a chalazion, but unusual enough in presentation that excisional biopsy was initially performed. Histopathologic analysis revealed a dermal fibrohistiocytic neoplasm consistent with cellular neurothekeoma. Neurothekeoma is a benign tumor; the cellular variant is rare and of unclear histogenesis. Completely internal eyelid location is particularly rare, with other identifiable case reports of cellular neurothekeoma palpebrae referring to external or unspecified eyelid location. This case provides an example of the chalazion as masquerader and re-emphasizes the importance of maintaining a broad differential diagnosis and high index of suspicion regarding atypically appearing chalazia.

Hyaluronic acid gel (Restylane) filler for facial rhytids: lessons learned from American Society of Ophthalmic Plastic and Reconstructive Surgery member treatment of 286 patients.

PURPOSE: To review injection techniques and patient satisfaction with injection of Restylane in various facial areas by American Society of Ophthalmic Plastic and Reconstructive Surgery members. METHODS: Data from 286 patients treated with Restylane in nine American Society of Ophthalmic Plastic and Reconstructive Surgery practices were abstracted to a spreadsheet for analysis. RESULTS: Nine practices performed Restylane injections for 8.8 months on average (range, 2 to 28 months). Average practice volume per patient was 1.2 ml (range, 0.7 to 2.1 ml). Nine of nine practices injected the nasolabial and melolabial folds, 9 of 9 practices injected the lips, and 6 of 9 injected the glabella. Only 2 of 9 practices injected other fillers concurrently. Botox was injected concurrently by 8 of 9 practices. On a scale of 1 to 10, physicians rated average patient discomfort during Restylane injection 4.6 with topical anesthesia and 2.1 with injectable lidocaine, with or without topical anesthesia. The end point for injection was determined by visual cues, volume of injection, extrusion of the product, and palpation. "Problematic" complications, including bruising, swelling, bumpiness, and redness each had an incidence of 5% or less. Patient satisfaction on a scale of 1 to 10 had an average rating of 8.1, compared with that of Botox injection (8.9), upper blepharoplasty (8.9), and collagen injection (6.6). The source of Restylane patients was estimated to be existing Botox patients (45%); existing non-Botox patients (18%); word of mouth (14%); and new patients for other services (13%). CONCLUSIONS: Injection techniques, volume, end points, and anesthesia vary for different facial areas and between practices. Patients experience mild to moderate injection discomfort that is lessened with injectable lidocaine. Self-limited problems occur in about 5% of patients. Physician-determined patient satisfaction is perceived to be higher than that of collagen injection but slightly lower than that of botulinum toxin injection. The major source of Restylane patients was from existing practice patients, especially botulinum toxin patients.

The smooth surface tunnel porous polyethylene enucleation implant.

BACKGROUND AND OBJECTIVE: To describe early clinical results with the porous polyethylene smooth surface tunnel (SST) enucleation implant. PATIENTS AND METHODS: Uncontrolled, prospective interventional case series of patients undergoing enucleation with placement of the SST implant. This implant consists of a porous polyethylene sphere with a smooth anterior surface containing pre-drilled tunnels to facilitate direct suturing of the rectus muscles to the implant without use of an implant wrap. Postoperatively, socket healing was assessed, and prosthesis and socket motility were evaluated by the surgeon using an ordinal scale (0 = no motility to 4 = excellent motility). RESULTS: Thirty patients received the SST implant, with a mean follow-up of more than 23 months. Two cases of exposure occurred and were managed surgically without the need for explantation. Mean socket motility was 3.1 on a 0 to 4 ordinal scale, with mean prosthesis motility of 2.8. CONCLUSION: The SST implant provides satisfactory socket motility and is generally well tolerated in the anophthalmic socket without the need for wrapping material.

Conjunctival melting syndrome associated with the use of bovine pericardium wrapping material.

PURPOSE: To report 18 cases of unusually large, early conjunctival breakdown occurring with the use of bovine pericardium wrapping material for orbital implants. METHODS: Retrospective case series. The clinical course and histopathologic features of 18 cases of early conjunctival breakdown in patients who had undergone orbital implantation of bovine pericardium-wrapped hydroxyapatite or porous polyethylene are reviewed. RESULTS: Eighteen patients presented with unusually large (average 13.44 mm) conjunctival defects over bovine pericardium-wrapped implants. The average time from enucleation to exposure was approximately 4 months. Implants had to be removed in 8 of 18 cases. There was clinical and histologic evidence of tissue inflammation and conjunctival melting. CONCLUSIONS: The conjunctival melting phenomenon we report herein is alarming. We have abandoned the use of bovine pericardium as a wrapping material for implants after enucleation because of the unfavorable results.

Enucleation versus evisceration.

Removal of the eye may be necessary after severe ocular trauma, to control pain in a blind eye, to treat some intraocular malignancies, in endophthalmitis unresponsive to medical therapy, and for cosmetic improvement of a disfigured eye. The choice of procedure to accomplish this is best made by an informed patient. Enucleation and evisceration can each achieve the desired goals, but several factors must be considered in choosing the most appropriate procedure.