Research and Publications
Current Research & Scholarly Interests
Thyroid Eye Disease (Video: TEPEZZA® - FDA-Approved Treatment)
Adenoid Cystic Carcinoma of the Lacrimal Gland
Lacrimal Gland Stimulation for the Treatment of Dry Eyes
Neurostimulation
Orbital Tumors
Floppy Eyelid Syndrome and Obstructive Sleep Apnea
View more information about our Thyroid Eye Disease Clinical Trials in our pamphlet or in the trial details below.
1. A phase 3b/4 double masked, randomized clinical trials to evaluate the safety, efficacy and tolerability of different dosing duration of Teprotumumab
Status: Active
Research Coordinator: Farheen (fqshaikh@stanford.edu)
For eligibility and more information, please see NCT05002998.
Background: This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.
2. A Phase 2b, Randomized, Double-Mask, Placebo Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease
Status: Active
Co-PI: Chrysoula Dosiou, MD, MS
Research Coordinator: Farheen (fqshaikh@stanford.edu)
For eligibility and more information, please see NCT05276063.
Background: The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).
3. Evaluate the safety, tolerability and Efficacy of VRDN-001, a monoclonal antibody in patients with Thyroid Eye disease
Status: Active
Research Coordinator: Farheen (fqshaikh@stanford.edu)
For eligibility and more information, please see NCT05176639.
Background: The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). This clinical trial will evaluate the safety, tolerability and pharmacokinetics (the concentration of drug in the blood over time) of VRDN-001 in healthy volunteers and in patients with TED. Study participants with TED will also be evaluated over time for changes in their signs and symptoms of TED compared to their baseline measurements.
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The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.
Investigator
Not accepting patients at this time View Details -
Surgical Idiopathic Intracranial Hypertension Treatment Trial
Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure. The determination of eligible eye(s) is based on meeting the eligibility criteria at baseline.
Investigators
Not accepting patients at this time View Details
Publications
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The use of Google Trends and Twitter data as a tool for evaluating public interest in hyaluronic acid eyelid filler.
Journal of clinical and translational research
Cohen, S. A., Kossler, A. L.
2023; 9 (2): 76-83
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Abstract
Google Trends and the Twitter Academic Research Product Tract (TARPT) are free, online tools that can be used to evaluate public interest in plastic surgery procedures.The aim of the study was to evaluate the correlation between online public interest in hyaluronic acid eyelid filler on two popular web platforms (Google and Twitter) and hyaluronic acid filler procedure volumes in the United States.The Google Trends database and the TARPT tool were used to calculate the number of annual Google searches and Twitter tweets, respectively, related to 10 search terms associated with hyaluronic acid eyelid filler injections from January 2010 to December 2020. Annual procedure volumes for hyaluronic acid filler injections were obtained from the American Society of Plastic Surgery (ASPS). Univariate linear regression was used to correlate Google searches to ASPS procedure volumes and Twitter tweet volumes to ASPS procedure volumes.Significant positive correlations were found between Google Trends data and ASPS procedure volumes for 8/10 search terms and between Twitter tweet volumes and ASPS procedure volumes for 6/10 search terms, respectively. Online public interest in eyelid filler related search terms increased significantly over time according to an exponential model (P < 0.0001).We observed statistically significant positive associations between public interest related to eyelid filler on two online platforms, Google and Twitter, and hyaluronic acid soft-tissue filler procedure volumes. The Google Trends and TARPT databases represent free information sources for surgeons that may be used to inform marketing and advertising decisions and to anticipate patient inquiries during the patient encounter.Information provided by the Google Trends and TARPT tools can be used by surgeons to (1) inform marketing and advertising strategies and (2) gain insight into which procedures patients are researching during a given time period, preparing them to best address the evolving needs of patients.
View details for PubMedID 37034000
View details for PubMedCentralID PMC10075089
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Transcutaneous retrobulbar amphotericin B for rhino-orbital-cerebral mucormycosis: a multi-center retrospective comparative study.
Orbit (Amsterdam, Netherlands)
Dallalzadeh, L. O., Ediriwickrema, L. S., Fung, S. E., Men, C. J., Kossler, A. L., Kupcha, A. C., Mawn, L. A., Burkat, C. N., van Landingham, S. W., Conger, J. R., Simmons, B., Pham, C., Akella, S. S., Setabutr, P., Ho, T., Couch, S. M., Kim, J. S., Demirci, H., Korn, B. S., Kikkawa, D. O., Liu, C. Y.
2023: 1-8
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Abstract
PURPOSE: To assess whether transcutaneous retrobulbar amphotericin B injections (TRAMB) reduce exenteration rate without increasing mortality in rhino-orbital-cerebral mucormycosis (ROCM).METHODS: In this retrospective case-control study, 46 patients (51 eyes) with biopsy-proven ROCM were evaluated at 9 tertiary care institutions from 1998 to 2021. Patients were stratified by radiographic evidence of local orbital versus extensive involvement at presentation. Extensive involvement was defined by MRI or CT evidence of abnormal or loss of contrast enhancement of the orbital apex with or without cavernous sinus, bilateral orbital, or intracranial extension. Cases (+TRAMB) received TRAMB as adjunctive therapy while controls (-TRAMB) did not. Patient survival, globe survival, and vision/motility loss were compared between +TRAMB and -TRAMB groups. A generalized linear mixed effects model including demographic and clinical covariates was used to evaluate the impact of TRAMB on orbital exenteration and disease-specific mortality.RESULTS: Among eyes with local orbital involvement, exenteration was significantly lower in the +TRAMB group (1/8) versus -TRAMB (8/14) (p=0.04). No significant difference in mortality was observed between the ±TRAMB groups. Among eyes with extensive involvement, there was no significant difference in exenteration or mortality rates between the ±TRAMB groups. Across all eyes, the number of TRAMB injections correlated with a statistically significant decreased rate of exenteration (p=0.048); there was no correlation with mortality.CONCLUSIONS: Patients with ROCM with local orbital involvement treated with adjunctive TRAMB demonstrated a lower exenteration rate and no increased risk of mortality. For extensive involvement, adjunctive TRAMB does not improve or worsen these outcomes.
View details for DOI 10.1080/01676830.2023.2186435
View details for PubMedID 36880205
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Reduction of Teprotumumab-Induced Hearing Loss With Comparable Efficacy Using Half-Dose Therapy.
Ophthalmic plastic and reconstructive surgery
Phansalkar, R., Lu, T., Alyono, J., Lee, J., Dosiou, C., Kossler, A. L.
2023
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Abstract
Teprotumumab has been shown to be effective in the treatment of thyroid eye disease, a potentially vision-threatening condition. Adverse events, including sensorineural hearing loss, have been associated with teprotumumab. The authors present the case of a 64-year-old female who discontinued teprotumumab due to significant sensorineural hearing loss after 4 infusions, along with other adverse events. The patient was unresponsive to a subsequent course of intravenous methylprednisolone and orbital radiation, during which she experienced worsening thyroid eye disease symptoms. Teprotumumab was restarted 1 year later, at a half dose of 10mg/kg for 8 infusions. Three months post-treatment, she retains resolution of double vision and orbital inflammatory signs, and significant improvement in proptosis. She tolerated all infusions with an overall reduction in the severity of her adverse events and without return of significant sensorineural hearing loss. The authors conclude that a lower dose of teprotumumab can be effective for patients with active moderate-severe thyroid eye disease who experience significant or intolerable adverse events.
View details for DOI 10.1097/IOP.0000000000002355
View details for PubMedID 36877549
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Oral Corticosteroids for Teprotumumab-Related Hearing Loss: A Case Report.
Case reports in ophthalmology
Lu, T. J., Amarikwa, L., Winn, B. J., Inserra, M., Dosiou, C., Kossler, A. L.
2023; 14 (1): 134-139
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Abstract
Teprotumumab is a novel insulin-like growth factor-1 receptor inhibitor approved for the treatment of thyroid eye disease, but growing reports of hearing loss require further investigation. To date, an effective protocol for managing hearing loss in this setting has not been determined. Here, we present the first report of the resolution of teprotumumab-related hearing loss with prompt oral prednisone. A 70-year-old woman on teprotumumab experienced sudden hearing loss and tinnitus after her first infusion. An audiogram demonstrated a mild down-sloping to moderately severe mixed conductive and sensorineural hearing loss that was promptly treated with prednisone 60 mg for 6 days with a 1-week gradual taper. An audiogram 3 weeks later demonstrated return of hearing to normal thresholds, and the whole teprotumumab treatment course was completed without further issue. This case highlights the importance of audiometric monitoring, prompt identification of hearing symptoms, and the potential for oral steroids to reverse teprotumumab-related hearing loss.
View details for DOI 10.1159/000529422
View details for PubMedID 37034380
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The Readability and Accountability of Online Patient Education Materials Related to Common Oculoplastics Diagnoses and Treatments.
Seminars in ophthalmology
Cohen, S. A., Tijerina, J. D., Kossler, A.
2022: 1-7
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Abstract
To assess the readability and accountability of online patient education materials related to oculoplastic diagnoses and treatments, and to determine the source of information encountered by patients searches.We conducted a Google search for 20 search terms related to common oculoplastic diagnoses and treatments and analyzed the first 10 patient education websites populated for each term. Readability was assessed using four validated measures: Gunning Fog Index, Flesch-Kincaid Grade Level, Simple Measure of Gobbledygook, and New Dale-Chall Readability. Accountability was assessed using 4 JAMA benchmarks on a scale of 0-4, with one point awarded for each of the following accountability criteria provided on the website: (1) including all authors and their relevant credentials (2) listing references (3) providing disclosures and (4) providing date of last update.The average grade level of 200 websites analyzed was 10.89, with 29% written at less than the 6th grade reading level recommended by the American Medical Association. The source of online information was most frequently educational institutions (36%) and private practices (34%), with fewer online patient education materials from national organizations (18%) and crowdsourced websites (12%). There were no significant differences in readability when comparing searches related to oculoplastics diagnoses versus treatments. Websites averaged 0.91 out of a maximum of 4 recommended accountability criteria, reflecting low overall accountability.Online education resources encountered by patients are often written at inappropriate reading levels and demonstrate low accountability. Online patient education materials are most frequently maintained by educational institutions and private practices, with fewer articles from national organizations. Revision of online materials may be necessary to improve health literacy among oculoplastic patients.
View details for DOI 10.1080/08820538.2022.2158039
View details for PubMedID 36524760