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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Erratum to "An Analysis of Solicitations From Predatory Journals in Ophthalmology," Am J Ophthalmol 2024; 264:216-223.
American journal of ophthalmology
Justin, G. A., Huang, C., Nguyen, M. K., Lee, J., Seddon, I., Wesley, T. A., Bakri, S. J., Campbell, J. P., Cavuoto, K., Collins, M., Gedde, S. J., Kossler, A. L., Milman, T., Shukla, A., Sridhar, J., Syed, Z. A., Williams, B. K., Woreta, F. A., Patel, S. N., Yonekawa, Y.
2025
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View details for DOI 10.1016/j.ajo.2025.04.014
View details for PubMedID 40316486
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Positional lagophthalmos variability in facial nerve palsy with and without upper eyelid loading.
Orbit (Amsterdam, Netherlands)
Lu, T. J., Nguyen, J., Kossler, A. L., Fay, A., Homer, N. A.
2025: 1-5
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Abstract
Lagophthalmos from facial nerve palsy is traditionally measured with patients in an upright position and may fail to identify positional variability. This study aims to assess the effects of body position, surgical technique, implant material, and patient demographics on lagophthalmos.A multicenter prospective study was performed to evaluate positional changes in paralytic lagophthalmos and the effects of various patient and surgical factors.Sixty-four eyelids were included. Thirty-two (50%) of eyelids had upper eyelid weight implantation with a median post-operative follow-up of 67 weeks. The mean change in lagophthalmos from sitting to supine was a 1.4 mm increase (p < 0.001). There was a larger lagophthalmos variability in patients with eyelid weights compared to those without (p = 0.047), and in patients with gold compared to platinum weights (p = 0.026). Positional increase in lagophthalmos did not correlate with weight position (i.e. pretarsal vs. supratarsal) (p = 0.26), weight load (p = 0.70), House-Brackmann severity (p = 0.16), age (p = 0.14), or gender (p = 0.13).Surgeons should routinely measure lagophthalmos in the supine position, as nocturnal corneal exposure may warrant ocular lubrication, occlusion, or additional surgery. Platinum weights may be preferred over gold due to less positional lagophthalmos variability.
View details for DOI 10.1080/01676830.2024.2444497
View details for PubMedID 39773315
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Reply Re: "Teprotumumab for the Treatment of Recalcitrant Thyroid Eye Disease"
OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY
Men, C. J., Amarikwa, L., Pham, B., Sears, C., Clauss, K., Lee, B. W., Lee, W. W., Pasol, J., Ugradar, S., Shinder, R., Cockerham, K., Wester, S., Douglas, R., Kossler, A.
2025; 41 (1): 111-112
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View details for DOI 10.1097/IOP.0000000000002875
View details for Web of Science ID 001394049900024
View details for PubMedID 39752221
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Clinical and Radiologic Predictors of Response to Teprotumumab: A 3D Volumetric Analysis of 35 Patients.
Ophthalmic plastic and reconstructive surgery
Ugradar, S., Parunakian, E., Zimmerman, E., Malkhasyan, E., Raika, P., Douglas, R. N., Kossler, A. L., Douglas, R. S.
2024
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Abstract
Teprotumumab, a novel human monoclonal antibody, has been shown to reverse the clinical manifestations of thyroid eye disease. Previous reports have suggested that it demonstrates disease-modifying properties through the reduction of orbital fat and muscle volumes. This study aims to analyze orbital volumetric change following treatment and to identify clinical and radiological predictors of response.This was a prospective longitudinal study with 35 consecutive patients who had available pre- and posttreatment orbital imaging. Three-dimensional volumetric calculations of orbital fat, extraocular muscles, and proptosis were measured using previously validated image processing software. This information was used with demographic data to create a multivariate regression model to review which baseline clinical or radiological factors were predictors of proptosis response.In the study orbit, 20 patients (57%) had a proptosis reduction of ≥2 mm. In the fellow orbit, 18 patients (51%) had a proptosis reduction of ≥2 mm. Regression modeling revealed that baseline proptosis and baseline muscle volumes were significant predictors of proptosis response (p < 0.01 and p < 0.05, respectively). Further, changes in muscle volume and fat volume were significantly associated with proptosis response (r = 0.5, p < 0.001 and r = 0.3, p = 0.012, respectively).Teprotumumab significantly reduces orbital fat and muscle volumes. This is manifested by a significant reduction in proptosis. Baseline proptosis and muscle volumes are significant predictors of proptosis response.
View details for DOI 10.1097/IOP.0000000000002867
View details for PubMedID 39714282
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Surgical Timing for Patients with Thyroid Eye Disease Treated with Teprotumumab: A Collaborative Multicenter Study.
Ophthalmic plastic and reconstructive surgery
Walsh, H. L., Clauss, K. D., Meyer, B. I., Parunakian, E., Yasar, C., Chiou, C. A., Johnson, T. E., Ugradar, S., Kossler, A. L., Freitag, S. K., Douglas, R. S., Wester, S. T.
2024
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Abstract
To compare regression rates, characteristics, and surgical outcomes of thyroid eye disease patients who underwent orbit, strabismus, or eyelid surgery at various times during or after teprotumumab treatment.Multicenter, retrospective, observational cohort study.Adult patients (age >18) with a minimum of 4 infusions of teprotumumab treatment for thyroid eye disease who had had eye surgery during or after treatment.Two groups were formed based on surgery timing: group 1 (G1) (<180 days since last infusion) and group 2 (G2) (≥180 days since last infusion).The primary outcome was postoperative regression rates. Secondary outcomes were postoperative regression characteristics, regression treatment, and orbital decompression proptosis reduction.This study evaluated 53 patients (81% female) who underwent 78 surgeries. G1 comprised 24 individuals with 34 surgeries, while G2 comprised 29 patients with 44 surgeries. Regression rates did not significantly differ between G1 and G2 (20.8% vs. 14.7%, p = 0.611). Compared with G1 patients, patients in G2 who regressed showed a significant mean increase in Clinical Activity Score (4.2 vs. 6.1, p = 0.027) and a nonsignificant yet measured increase in proptosis when compared with those in G1 (2.9 vs. 4.25, p = 0.298) at the time of regression. Compared with G1 patients, G2 patients who regressed were equally likely to undergo a repeat course of teprotumumab as group 1 (p = 0.14) but underwent a higher number of additional surgical procedures (p = 0.057). Thyroid stimulating immunoglobin levels uptrended more often in patients who regressed.Our study suggests that while the rate of regression may not differ significantly, the severity, clinical impact, and need for additional surgery might be more pronounced for patients who have surgery more than 6 months after their last teprotumumab dose.
View details for DOI 10.1097/IOP.0000000000002839
View details for PubMedID 39656059
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Orbital Subperiosteal Abscess Drainage: Transorbital vs. Endonasal Approach.
Journal of clinical medicine
Luthra, S., Kossler, A. L., Erickson, B. P., Homer, N. A.
2024; 13 (23)
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Abstract
Background: This study aims to compare the surgical outcomes of transorbital versus endonasal endoscopic approaches for orbital subperiosteal abscess drainage. Methods: A retrospective review was conducted at a single institution of patients who underwent orbital subperiosteal abscess drainage from November 2009 to April 2023. Results: Of 64 patients, 44 (68.8%) underwent abscess drainage via an orbital approach, while 20 (31.3%) underwent endonasal endoscopic drainage. No significant difference in operative time or visual acuity improvement was found between the two groups. Abscess drainage via orbitotomy was associated with a longer total (average 8.1 days) and postoperative (average 7.3 days) hospitalization time compared to the endoscopic group (average 5.4 days and 4.2 days, respectively), though this difference was not statistically significant (p = 0.197, 0.136, respectively). For medial orbital abscesses, the average length of total and postoperative hospitalization was greater after orbitotomy (p = 0.028 and 0.019, respectively). At discharge, patients who underwent orbitotomy more commonly reported periorbital swelling (p = 0.0003), while postoperative pain was more common in the endoscopic drainage group (p = 0.009). Reoperation rate was higher after orbitotomy (34.1%) compared to the endoscopic drainage group (15.0%), though this was not statistically significant (p = 0.115). Conclusions: Transorbital and endoscopic surgical approaches for orbital abscess drainage have similar surgical outcomes, with no statistically significant differences noted in terms of visual acuity change or reoperation rate. Longer hospital stays were found for patients with medial orbital abscesses drained via orbitotomy.
View details for DOI 10.3390/jcm13237011
View details for PubMedID 39685468
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Reply to Comment on Ophthalmic Immune-Related Adverse Events and Association with Survival: Results from a Real-World Database.
American journal of ophthalmology
Quiruz, L., Yavari, N., Kikani, B., Gupta, A. S., Wai, K. M., Kossler, A. L., Ludwig, C., Koo, E. B., Rahimy, E., Mruthyunjaya, P.
2024
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View details for DOI 10.1016/j.ajo.2024.11.001
View details for PubMedID 39528009
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Innovate Thyroid Eye Disease 2024 Multidisciplinary Symposium-April 26-28, 2024, Napa, California
OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY
Kossler, A. L., Stan, M., Kazim, M., Dosiou, C.
2024; 40 (6): 714
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View details for DOI 10.1097/IOP.0000000000002837
View details for Web of Science ID 001350945600013
View details for PubMedID 39495663
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Risk of Intestinal Complications, Extraintestinal Morbidity, and Mortality in Patients with Crohn's Disease and Ocular Involvement.
Ocular immunology and inflammation
Alsoudi, A. F., Wai, K. M., Koo, E., McConnell, R. A., Pham, N. H., Do, B. K., Ludwig, C. A., Kossler, A. L., Mruthyunjaya, P., Rahimy, E.
2024: 1-8
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Abstract
Patients with Crohn's disease (CD) and subsequent ocular manifestations may have worse outcomes when compared to matched patients with CD without ocular disease.In this retrospective cohort study, an aggregated electronic health records research network, TriNetX (Cambridge, MA, USA), was used to identify patients diagnosed with CD stratified by the presence or absence of ocular involvement with at least 1 year of follow-up. Propensity score matching (PSM) was performed to control for baseline demographics and medical comorbidities.Patients with CD with ocular disease showed a greater risk of undergoing bowel resections (RR: 2.06, 95% CI: 1.48-2.85, p < 0.001), developing other CD-related gastrointestinal complications (RR: 1.31, CI: 1.15-1.49, p < 0.001), or acquiring Clostridioides difficile infections (RR: 2.19, CI: 1.89-2.54, p < 0.001). Further, patients with CD with ocular sequelae had a greater risk of developing NASH (RR: 1.43, CI: 1.31-1.56, p < 0.001), CD-related nutrient deficiencies (RR: 1.38, CI: 1.29-1.49, p < 0.001), iron deficiency anemia (RR: 1.41, CI: 1.33-1.50, p < 0.001), CD-related dermatological disease (RR: 1.84, CI: 1.65-2.05, p < 0.001), osteoporosis (RR: 1.49, CI: 1.37-1.64, p < 0.001) and primary sclerosing cholangitis (RR: 1.63, CI: 1.11-2.38, p = 0.011). Among patients with CD with ocular involvement, there was an elevated risk of MI (RR: 1.36, CI: 1.14-1.63, p < 0.001), stroke (RR: 1.42, CI: 1.18-1.70, p < 0.001), VTE (RR: 1.37, CI: 1.22-1.54, p < 0.001), and sepsis (RR: 1.53, CI: 1.37-1.71, p < 0.001).Patients who have CD and subsequent ocular involvement have an increased risk of local intestinal complications, extraintestinal morbidity, and cardiovascular complications when compared to patients with CD without ocular involvement.
View details for DOI 10.1080/09273948.2024.2413895
View details for PubMedID 39401331
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Comparing the Ability of Google and ChatGPT to Accurately Respond to Oculoplastics-Related Patient Questions and Generate Customized Oculoplastics Patient Education Materials.
Clinical ophthalmology (Auckland, N.Z.)
Cohen, S. A., Yadlapalli, N., Tijerina, J. D., Alabiad, C. R., Chang, J. R., Kinde, B., Mahoney, N. R., Roelofs, K. A., Woodward, J. A., Kossler, A. L.
2024; 18: 2647-2655
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Abstract
To compare the accuracy and readability of responses to oculoplastics patient questions provided by Google and ChatGPT. Additionally, to assess the ability of ChatGPT to create customized patient education materials.We executed a Google search to identify the 3 most frequently asked patient questions (FAQs) related to 10 oculoplastics conditions. FAQs were entered into both the Google search engine and the ChatGPT tool and responses were recorded. Responses were graded for readability using five validated readability indices and for accuracy by six oculoplastics surgeons. ChatGPT was instructed to create patient education materials at various reading levels for 8 oculoplastics procedures. The accuracy and readability of ChatGPT-generated procedural explanations were assessed.ChatGPT responses to patient FAQs were written at a significantly higher average grade level than Google responses (grade 15.6 vs 10.0, p < 0.001). ChatGPT responses (93% accuracy) were significantly more accurate (p < 0.001) than Google responses (78% accuracy) and were preferred by expert panelists (79%). ChatGPT accurately explained oculoplastics procedures at an above average reading level. When instructed to rewrite patient education materials at a lower reading level, grade level was reduced by approximately 4 (15.7 vs 11.7, respectively, p < 0.001) without sacrificing accuracy.ChatGPT has the potential to provide patients with accurate information regarding their oculoplastics conditions. ChatGPT may also be utilized by oculoplastic surgeons as an accurate tool to provide customizable patient education for patients with varying health literacy. A better understanding of oculoplastics conditions and procedures amongst patients can lead to informed eye care decisions.
View details for DOI 10.2147/OPTH.S480222
View details for PubMedID 39323727
View details for PubMedCentralID PMC11423829