Teprotumumab Related Hearing Loss: A Large-Scale Analysis and Review of Voluntarily Reported Patient Complaints to the Food and Drug Administration (FDA).

PURPOSE: Accumulating case reports and series have suggested that teprotumumab may significantly increase the risk of hearing impairment that, in some cases, does not resolve. This study investigates the association between hearing impairment and teprotumumab use. METHODS: A disproportionality analysis was conducted using the United States Food and Drug Administration Adverse Event Reporting System, a publicly accessible database used for postmarketing surveillance and research. All adverse event reports containing the terms "teprotumumab" or "Tepezza" and a similar comparison group from all patients with the same indications for teprotumumab use (e.g., autoimmune thyroiditis, endocrine ophthalmopathy, and hyperthyroidism) but who had not received the drug were selected. Hearing impairment events were identified using the hearing impairment Standardized MedDRA Query. RESULTS: A total of 940 teprotumumab-associated adverse events were identified, including 84 hearing-related adverse events, with the first reported to the Food and Drug Administration in April 2020. A comparison group of 32,794 nonteprotumumab adverse events was identified with 127 hearing-related adverse events reported. Use of teprotumumab in patients with thyroid conditions was associated with a nearly 24-fold (proportional reporting ratio [PRR] 23.6, 95% confidence interval [CI]: 18.1-30.8) increased likelihood of any hearing disorder (p value <0.0001). The association was specifically elevated for a variety of deafness conditions (e.g., bilateral deafness [PRR: 41.9; 95% CI: 12.8-136.9]), Eustachian tube disorders (PRR: 34.9; 95% CI: 4.9-247.4), hypoacusis (PRR: 10.1; 95% CI: 7.6-13.3), and tinnitus (PRR: 8.7; 95% CI: 6.2-12.1). CONCLUSIONS: Patients treated with teprotumumab should receive warnings regarding the increased risk of hearing-related impairments and receive audiometry before, during, and after treatment.

Bilateral Spontaneous Retrobulbar Hemorrhage due to Warfarin Misuse After Sinus Lavage.

While warfarin has historically played an important role in anticoagulation, direct oral anticoagulants have largely supplanted warfarin due to their improved safety profile and reduced need for monitoring. Herein, the authors report the case of a 64-year-old male who developed severe, bilateral retrobulbar hemorrhage following aggressive nasal lavage due to a supratherapeutic international normalized ratio from warfarin misuse. Visual acuity on arrival was hand-motion OD and no-light-perception OS. He underwent bilateral canthotomy with upper and lower lid cantholysis before transfer to a trauma center where his international normalized ratio was greater than 12. Reversal with vitamin K and prothrombin complex concentrate was initiated. Over the course of hospitalization, vision and swelling continued to improve and at 2-month follow-up his visual acuity was 20/20 OD and no-light-perception OS. This case outlines the risk of bleeding associated with warfarin misuse and advocates for the transition of patients to direct oral anticoagulants when possible.

High incidence and recurrence of tympanostomy tube procedures in children who underwent nasolacrimal duct probe and intubation for congenital nasolacrimal duct obstruction.

PURPOSE: To determine the incidence of tympanostomy tube (T-tube) insertion in children who required probing and intubation for congenital nasolacrimal duct obstruction (CNLDO) at a single academic institution and to analyze success rates. METHODS: The medical records of 92 patients who underwent nasolacrimal probing and intubation for CNLDO over a 9-year period were reviewed retrospectively. A preoperative questionnaire was given to the patient's guardian concerning laterality of CNLDO, history of otitis media (OM) antibiotic therapy, history of T-tube placement and number placed. At least 12 months following the initial nasolacrimal duct P&I, a second questionnaire was administered regarding resolution of CNLDO symptoms, additional measures taken to relieve postoperative symptoms if present, and any further history regarding OM episodes or T-tube insertion. RESULTS: Of the 92 children with CNLDO, 37 (40%) required T-tubes either prior to or following nasolacrimal duct probing and intubation, a rate higher than in the general population (P < 0.00001). 21 (56%) of CNLDO probing and intubation patients who required T-tubes required at least two sets, at different times, to relieve OM symptoms. Six of 37 patients (16%) with a history of T-tube placement and 1 of 55 (2%) with no history of T-tube placement had persistent epiphora after nasolacrimal probing and intubation (relative risk, 8.92; P = 0.0388). CONCLUSIONS: In our study cohort, pediatric patients with CNLDO who required nasolacrimal probing and intubation were at higher risk of needing T-tubes for chronic OM than the general population, and those needing T-tubes were at increased risk of residual epiphora.

The Association Between Taxane Use and Lacrimal Disorders.

PURPOSE: The current study seeks to investigate the association between lacrimal disorders and the use of docetaxel and paclitaxel. METHODS: A disproportionality analysis was conducted using the United States FDA Adverse Event Reporting System (FAERS). All adverse event reports containing the term docetaxel or paclitaxel were selected. Lacrimal adverse events were identified using the lacrimal disorders Standardized MedDRA Query (SMQ), which includes disorders that affect lacrimal gland and drainage system including blockage of nasolacrimal duct, occlusion/stenosis of punctum, lacrimal gland neoplasms, and inflammations and infections. RESULTS: The proportionate reporting ratio (PRR) comparing lacrimal events among docetaxel to paclitaxel users was 2.47 (95% CI, 2.03-3.02). With respect to specific lacrimal events, dacryostenosis (PRR 19.54 [95% CI, 7.19-53.13]), increased lacrimation (PRR 3.2 [95% CI, 2.42-4.23]), lacrimation disorder (p = 0.02), and xeropthalmia reports (p > 0.001) were significantly more common. CONCLUSIONS: The growing body of epidemiologic, clinical, and pathophysiologic research supports the case that docetaxel leads to adverse lacrimal events in certain patients and should be taken into consideration when oncologists consider docetaxel vs. paclitaxel.

Bilateral pneumatic blowout fractures in a patient with silent sinus syndrome while diving.

A 37-year-old scuba diver developed sudden severe headache, mid-facial pressure/pain and diplopia while diving. Upon examination, he had signs and symptoms consistent with silent sinus syndrome (SSS), including bilateral enophthalmos, hypoglobus, and diplopia/strabismus in conjunction with CT findings of occluded maxillary sinus ostia, atrophic/collapsed maxillary sinuses, and bilateral orbital floor fractures with fat herniation. As there was no history of trauma or chronic sinusitis, this rare case of bilateral SSS was deemed the cause of the spontaneous fractures (i.e. barotrauma secondary to a lack of equalization to ambient surrounding pressure). Transconjunctival repair of the fractures was successful and maxillary sinus antrostomies re-established aeration of the sinuses. We present this case and its management, as well as review the literature concerning sinus barotrauma as a result of diving and SSS. There have been no reports of orbital fractures primarily caused by scuba diving, nor secondarily from diving with the rare entity, SSS.

Liposomal Bupivacaine Suspension for Pain Control Following Ocular Evisceration Surgery.

PURPOSE: To determine the effectiveness of retrobulbar liposomal bupivacaine for controlling postoperative pain following evisceration, compared with 0.75% bupivacaine. METHODS: Randomized controlled trial, in which the postoperative pain scores from 24 patients who had retrobulbar liposomal bupivacaine after an evisceration were compared with the pain scores from 24 patients eviscerated using 0.75% bupivacaine. RESULTS: Patients who received liposomal bupivacaine reported significantly less pain at 24 hours (2.0 out of 10, p = 0.01) and 48 hours (2.2 out of 10, p = 0.01) after surgery than patients who received 0.75% bupivacaine (5.7, and 5.0, respectively). The postoperative pain scores at 1 hour and at 7 days did not significantly differ between the 2 groups. Significantly, fewer patients who received liposomal bupivacaine (0%) than patients who received 0.75% bupivacaine (16.7%) returned emergently during the postoperative period for uncontrolled pain (p ≤ 0.001). CONCLUSIONS: Retrobulbar liposomal bupivacaine is more effective than 0.75% bupivacaine for controlling pain during the first 2 days after evisceration and should be considered for patients undergoing this procedure.

Safety Comparison of Laryngeal Mask Use With Endotracheal Intubation in Patients Undergoing Dacryocystorhinostomy Surgery.

PURPOSE: This study will determine the safety of laryngeal mask airway (LMA) compared with endotracheal tube (ETT) in patients undergoing general anesthesia for dacryocystorhinostomy (DCR) surgery. METHODS: In this retrospective cohort study, intraoperative and postoperative outcomes of patients who underwent DCR at UAB Callahan Eye Hospital using either LMA or ETT were compared. RESULTS: Over a period of 52 months, 429 patients underwent external DCR surgery. An ETT was used in 37 patients and LMA in 392 patients. Baseline patient characteristics and anesthetic management were similar. No documented cases of blood or gastric aspiration occurred in the total cohort. Our study confirmed the findings of others that there is less cardiovascular lability on LMA placement than with ETT intubation. A 30% increase in heart rate from baseline after intubation (ETT 10.8%, LMA 1.8%; p = 0.010) and after incision (ETT 8.1%, LMA 1.8%; p = 0.047) occurred more frequently in the ETT group. Airway management with an LMA was also less difficult compared with an ETT (ETT 5.7%, LMA 0.5%; p = 0.035). CONCLUSIONS: The use of an LMA for airway control is safe and effective in patients undergoing general anesthesia for DCR surgery. No events of aspiration occurred with LMA use. Heart rate increase was significantly less in the LMA group. In our opinion, use of an LMA for airway control during DCR surgery is superior to use of an ETT. Airway protection, improved hemodynamics, and less difficulty in placement of the laryngeal airway device are all validated by this study.

Autogenous Fascia Lata Graft Fixation to Treat Exotropia Resulting From Iatrogenic Medial Rectus Transection.

PURPOSE: To describe autogenous fascia lata graft fixation as a novel method to treat exotropia related to medial rectus (MR) muscle injury following functional endoscopic sinus surgery. METHODS: Three consecutive patients with MR transection and exotropia after functional endoscopic sinus surgery were selected. Preoperative examination was performed; no MR function was noted for over 3 months after injury. CT and dynamic functional MRI were performed, where MR transection and medial wall breach were noted. An autogenous fascia lata graft was harvested and fixated from the remaining periosteum of the posterior-most extent of the medial orbital wall and attached to the globe at the MR insertion. In addition, an ipsilateral lateral rectus muscle recession was performed. RESULTS: Alignment of the eyes in primary gaze and downgaze was achieved and remained so at the 3-month postoperative examinations, with minimal head turn or prism correction (<5 prism diopters) necessary to control diplopia. Two patients required recession of the fascial graft for a minor overcorrection and have remained stable for over 6 months. CONCLUSIONS: Severe exotropia secondary to MR damage following functional endoscopic sinus surgery is a known complication historically difficult to treat. Traditional surgical methods, including vertical muscle transposition, commonly result in complete recurrence of exotropia and increase risk of anterior ocular ischemia. Unlike simple nonabsorbable suture fixation, fascial grafts are completely biointegratable, do not result in significant inflammation, and are unlikely to rupture. Fascia lata graft fixation of the MR to the posterior orbital medial wall is a new and successful method to eliminate exotropia after MR injury.

Interreader Variability of Computed Tomography for Orbital Floor Fracture.

IMPORTANCE: The timing and indications for repair of orbital floor fractures have been controversial. Current practice dictates that fractures involving more than 50% of the orbital floor should be repaired. Early management is initiated in such situations to prevent long-term sequelae of enophthalmos and diplopia. Because fracture size as measured by computed tomography (CT) is one of the criteria to determine the need for surgical repair, there is a need to know the reliability of this parameter. OBJECTIVE: To assess the variability of CT measurements of orbital floor fractures. DESIGN, SETTING, AND PARTICIPANTS: This study took place between January 1, 2005, and June 1, 2007, at an urban academic medical center. Patients with isolated orbital floor fractures were evaluated by 1 oculoplastic surgeon, and their orbital CT images were subsequently read by 3 neuroradiologists blinded to demographic information and the other readers' measurements. Separately, each was asked to determine the maximal anterior to posterior length and transverse width if a floor fracture existed. MAIN OUTCOMES AND MEASURES: Intraclass correlation coefficients were calculated for length and width using a 2-way mixed-effects model to evaluate the agreement between radiologists. RESULTS: Twenty-three patients met criteria for inclusion in this study (isolated orbital fracture thought to be in need of repair, with diplopia within 30° of primary gaze, and/or enophthalmos >2 mm, and/or 50% of the floor area involved in the fracture). The mean (SD) age of the patients was 31.5 (17.6) years (range, 8-73 years). The magnitude of agreement between the readers as measured by the intraclass correlation coefficient was 0.66 (95% CI, 0.46-0.82) for anterior to posterior length and 0.44 (95% CI, 0.22-0.69) for transverse width, indicating only a moderate degree of concordance. CONCLUSIONS AND RELEVANCE: Although the literature has long held that a floor fracture seen radiographically to involve 50% of the orbital floor has a high likelihood of enophthalmia and should be repaired, this study shows how variable CT measurements of orbital floor fractures can be in a clinical setting, even in trained hands. We question the dependence on such a criterion and reemphasize the importance of making surgical decisions based on clinical findings rather than radiological interpretations.

The Prevalence of Air Regurgitation and Its Consequences After Conjunctivodacryocystorhinostomy and Dacryocystorhinostomy in Continuous Positive Airway Pressure Patients.

PURPOSE: To describe the prevalence of air regurgitation into the periocular region in continuous positive airway pressure (CPAP) patients with a history of conjunctivodacryocystorhinostomy with a Lester Jones tube and a dacryocystorhinostomy with silicone intubation, as well as problems caused by this regurgitation and methods to cope. METHODS: A retrospective chart review of patients who either underwent a conjunctivodacryocystorhinostomy or dacryocystorhinostomy was performed. Patients were contacted via phone interview. Demographic information, history of sleep apnea, use of CPAP, and presence of air regurgitation and associated complications were recorded. Institutional review board/ethics committee approval was obtained. RESULTS: Two patients who underwent a conjunctivodacryocystorhinostomy with Lester Jones tube and were on CPAP were identified. Both complained of air regurgitation, sensation of Lester Jones tube moving due to regurgitation, and periodic eye pain. Twenty-two patients who underwent a dacryocystorhinostomy with silicone stent and used CPAP were identified. Of these, 16 (72.7%) complained of air regurgitation. Difficulty sleeping (56.2%), dry eye symptoms upon waking (68.8%), eye pain upon waking (31.3%), and blurry vision upon waking (12.5%) were the commonest complaints due to air regurgitation. A total of 7 (43.7%) patients had to discontinue their CPAP at some point due to symptoms. CONCLUSIONS: This study brings to light the prevalence of air regurgitation in dacryocystorhinostomy procedures, and its associated symptoms. Given that this procedure is much more common than conjunctivodacryocystorhinostomy, surgeons should consider asking patients before performing surgery whether they use CPAP. Patients should be consented regarding the risk of air regurgitation and associated dry eye, foreign body sensation, and eye pain.

A novel surgical technique for the treatment of giant fornix syndrome.

PURPOSE: To describe a novel surgical treatment for patients with chronic relapsing conjunctivitis, corneal epitheliopathy, and ptosis secondary to giant fornix syndrome. METHODS: A retrospective case series was performed looking at the presence or absence of preoperative symptoms of eye irritation, tearing, blurry vision, and discharge in 6 patients diagnosed with giant fornix syndrome. Their examination findings were noted, and all patients underwent an extensive conjunctivoplasty with resection of redundant forniceal conjunctiva with subconjunctival antibiotics. Final visual acuity, symptoms, and examination findings were noted with a minimum follow up of 9 months. RESULTS: Six patients were treated from November 2009 to November 2011. Duration of symptoms ranged from 3 to 40 months. Four patients were women while 2 were men, with age ranging from 61 to 85 years. Common symptoms were severe mucopurulent discharge, eye redness, tearing, and irritation with examination findings of severe conjunctival discharge and injection, corneal epitheliopathy, upper eyelid ptosis, and a deep upper and lower eyelid fornix. Most patients had undergone previous treatments with topical and/or oral antibiotics or steroids. All patients underwent surgical intervention using the surgical technique to be described with resolution of their symptoms, and even an improvement of 2 or more lines of best corrected visual acuity (3 of 5 patients). CONCLUSIONS: The authors' novel surgical technique helps restore the abnormal anatomy found in patients with giant fornix syndrome and thus, helps resolve chronic relapsing conjunctivitis and surface disease associated with this often underdiagnosed condition. Further studies are needed to evaluate the risk of entropion and dry eye syndrome due to the modification of the posterior lamella.

Diagnosis and management of an intraorbital vascular fistula.

A spontaneous intraorbital arteriovenous fistula is an extremely rare phenomenon. More commonly, arteriovenous fistulas occur spontaneously as carotid cavernous fistulas and dural cavernous fistulas or are secondary to trauma. Surgical approaches vary widely and each carries their own set of potential problems. The purpose of this single case report was to provide an example of a successful treatment of a rare, spontaneous intraorbital vascular fistula.

Patient experience with blepharoplasty.

PURPOSE: To prospectively study patients' postoperative experience with blepharoplasty and to determine how closely patients' expectations compare with their actual experience. METHODS: A prospective observational study of 51 consecutive patients undergoing bilateral upper eyelid blepharoplasty by a single surgeon (J.A.L.) between October 2008 and May 2009 was performed. Prior to surgery, patients were asked to rate, on a scale of 1 to 10, their expectations of pain, swelling, bruising, blurred vision, impairment of ability to function in daily activities, and itching. Patients were then asked to rate these 6 elements at 7 time points: 30 minutes, 4 hours, 24 hours, 2 days, 3 days, 1 week, and 2 months. The number of pain pills utilized was also assessed. An analysis of the data was performed to determine our patients' experience with blepharoplasty surgery. The paired t test was used to determine the statistical significance of patients' expectations compared with their actual reported experience. RESULTS: In this cohort of patients, the authors found the following: blurred vision and impairment in ability to function peaked in the immediate postoperative period, pain peaked at 4 hours, swelling and bruising peaked at 24 hours, and itching peaked at 3 days. The mean number of narcotic pain pills used by patients in the postoperative period was 2.45. Patients underestimated the degree of swelling, blurred vision, and impairment in ability to function experienced following surgery. CONCLUSIONS: Postoperative patient experience with blepharoplasty is based largely on anecdotal evidence; the data from this study will facilitate more objectively based preoperative counseling.

High versus low concentration botulinum toxin A for benign essential blepharospasm: does dilution make a difference?

PURPOSE: To evaluate the efficacy and side effects of concentrated versus dilute botulinum toxin A in treating benign essential blepharospasm. METHODS: The authors performed a prospective randomized clinical trial of 16 patients with an established diagnosis of benign essential blepharospasm. Patients were randomized to receive low concentration (control, 10 U/ml) injections on one side and high concentration (experimental, 100 U/ml) injections on the other. They were surveyed on a scale of 1 to 10 regarding pain, bruising, and redness immediately after the injection. During their return visit, at an established interval of 1 to 3 months, patients were questioned regarding complications (ptosis, diplopia, tearing, and dry eye), duration of relief, and side preferred. Patients were followed over 8 months for 1 to 6 repeat injections, with the side given the higher concentration alternated at each visit. RESULTS: With 16 patients, there were a total of 42 visits and 84 observations (eyes) documented. Using the Wilcoxon rank sum test, there was a statistically significant reduction in pain scores (1.94 vs. 4.59, p < 0.001) on the experimental side versus the control side. Patient assessment revealed no significant difference in bruising, redness, complications of injection, side preference, or length of relief of symptoms. CONCLUSIONS: Compared with the control, the high concentration botulinum toxin A demonstrated a 58% reduction in perceived pain. Patients did not report a significant difference in efficacy or complications with either dilution.

The consequence of premature silicone stent loss after external dacryocystorhinostomy.

PURPOSE: To investigate the clinical affects of premature silicone stent loss after external dacryocystorhinostomy (DCR). DESIGN: Retrospective chart review. PARTICIPANTS: Two hundred thirty-three consecutive external dacryocystorhinostomies. METHODS: Demographic information was recorded, including length to follow-up, age, gender, number of days until stent removal, and success of surgery. All patients who extruded their silicone stent prematurely were identified. All were primary DCRs (i.e., all reoperations were excluded). All patients had had documented nasolacrimal duct obstruction before surgery, with or without current or prior dacryocystitis. MAIN OUTCOMES MEASURES: Failure of DCR surgery was accepted as symptomatic epiphora with notable nasolacrimal duct blockage and/or infection at long term follow-up. RESULTS: Of the 233 DCRs, 42 stents extruded or had to be removed before the planned 2-month period. The overall success rate of the surgery was 94.9%, with a 90.5% success for those who had early extrusion and 95.8% for those who did not (P = 0.24). Moreover, of the 4 people who had a failed surgery (of 42 early extrusions), none had a recurrent infection or pain, and only 1 opted to have a revision of the surgery. Patient age, gender, or timing of the extrusion was not found to affect surgical success significantly. CONCLUSIONS: Our experience and this study suggest that concerns over early stent extrusion or removal may not be wholly warranted. Moreover, our review of the literature shows no evidence-based recommendations that longer stent retention or reintubation after early extrusion results in a higher success rate. Although other surgeries (e.g., canalicular laceration, congenital epiphora) may benefit from intervention or reinsertion after early extrusion, we cannot extrapolate such a practice for the DCR.

Unusual presentation of gastric adenocarcinoma metastatic to the orbit.

A 69-year-old woman with no history of malignant disease presented with complaints of ptosis, diplopia, and left upper eyelid fullness. Computed tomography showed soft tissue infiltration of the left superior orbit. Biopsy was performed through an anterior orbitotomy. Histopathology revealed a mucinous adenocarcinoma. Subsequent systemic evaluation included esophagogastroduodenoscopy, which revealed a primary gastric malignancy.