Update on "Cell Therapy" Clinics Offering Treatments of Ocular Conditions Using Direct-To-Consumer Marketing Websites in the U.S.

PURPOSE: To assess the scope of U.S.-based companies advertising and administering non-Federal Drug Administration (FDA) approved cell-based therapy (herein called NFACT) for ocular conditions based on information from companies' public websites after the FDA's legal actions against specific NFACT clinics in 2018 and 2019. Current findings are compared to previously published data from 2017. DESIGN: Trend study looking at U.S.-based companies that use direct-to-consumer marketing and have websites advertising therapy for ocular conditions. METHODS: A systematic and extensive keyword-based Internet search was utilized to identify, document, and analyze U.S. business websites offering NFACT for ocular conditions as of August 2022. Main outcomes measured include, clinic locations, marketed ocular conditions, types of NFACT offered, source of stem cells used, routes of administration, and treatment costs. RESULTS: From the prior analysis in 2017 to the 2019 analysis, there was a decrease in the number of NFACT clinics from 76 to 62 and companies from 40 to 39. Given the concerning persistence of NFACTs in August 2019 an additional analysis was performed in 2022 which showed a drastic decrease in NFACT clinics from 62 in 2019 to 18 in 2023 and from 39 companies to 13 in 2023. In both 2019 and 2022, the most commonly referenced ocular condition was age-related macular degeneration (2019-72%, 2022-92%). The state with the most clinics was in Texas (2019-12; 2022-5). Autologous adipose-derived stem cells were the most common cell type used in both analyses. CONCLUSIONS: In 2019 U.S.-based direct-to-consumer companies marketing NFACT persisted despite (1) a lack of high-quality clinical evidence supporting the efficacy of these procedures, (2) the association of some of these treatments with severe vision loss, and (3) increasing FDA oversight and recent legal action. In 2022 the number of clinics and companies decreased, but their persistence is a reminder that continued concern is necessary and ophthalmic associations need to continue advocacy efforts to protect patients from these potentially predatory organizations.

Ergonomics of Ophthalmic Surgery: Evaluating the Effect of a Posture Trainer on Trainee Intraoperative Back Posture.

Purpose Ophthalmic surgeons are at an increased risk for musculoskeletal disorders resulting from ophthalmology-specific routines and equipment, which have become widely associated with poor posture. The purpose of this study was to observe the effect that a commercially available posture trainer, Upright Go, can have on the improvement of posture of ophthalmic surgeons. Methods Eight ophthalmologists-in-training were studied over a period of 4 weeks during their surgical rotations between September 2020 and June 2021. Participants underwent an "observation" period, followed by a 2-week "training" period, then a final "testing" period. The percentage of time users spent upright intraoperatively pre- and posttraining was evaluated. Pre- and poststudy surveys were also administered to help measure participant satisfaction and self-reported changes in posture. Results All eight participants demonstrated an increase in the percentage of time spent upright after the training period. Across all participants, the total average percentage spent upright in the observation period was 59.8%, while in the testing period was 87.1%, resulting in an average improvement of 27.3% of time spent in an upright position after the completion of the training period ( p < 0.0001). The range of improvement of time spent upright was 16.0 to 46.5%. Conclusion This cohort study utilized the Upright Go device to help determine the effect that its training could have on the improvement of posture in ophthalmic surgeons. The results indicated a significant increase in the average proportion of time spent with upright posture compared after the training period.

Purtscher-like retinopathy in patients with COVID-19.

Purpose: Several ophthalmological complications of coronavirus disease 2019 (COVID-19) involving the anterior and posterior segment have been reported in the literature. We present two patients with Purtscher-like retinopathy presenting with bilateral central vision loss and diffuse peripapillary cotton wool spots extending into the macula bilaterally. Observations: In both cases, the patients were diagnosed with COVID-19 within a week of their presentations and had relatively mild courses of COVID-19. In the first case, the patient's vision was hand motion in the right eye and count fingers in the left eye. A broad workup was negative, revealing no concerns for underlying conditions traditionally associated with Purtscher-like retinopathy. Head and neck imaging was also negative for vascular abnormalities. The patient was given a diagnosis of Purtscher-like retinopathy due to COVID-19 infection and was started on 60 mg of oral prednisone. At 4-week follow up, patient's vision had improved to 20/100 in the right eye and 20/80 in the left eye, although she continued to have minimal central vision. The patient continued to have Purtscher flecken in the posterior pole, but the density of the opacities and retinal hemorrhages had significantly improved. In the second case, the patient's past medical history was significant for Huntington's disease and kidney transplant on dialysis but she had not had any ocular issues prior. One week within diagnosis of COVID-19, she presented with a vision of count fingers in the right eye and 20/400 in the left eye. The patient's baseline dose of 5 mg prednisone was increased to 60 mg for 1 week. She received an Ozurdex implant in both eyes. The patient's vision at 9 week follow up improved to 20/40 pinholing to 20/25 in the right eye and 20/200 pinholing to 20/70 in the left eye and dilated exam showed improving edema and improving density of Purtscher-flecken from initial presentation. Conclusions and importance: Very few cases of COVID-19 associated Purtscher-like retinopathy have been reported in the literature and all have been reported with serious clinical courses of COVID-19. To the best of our knowledge, these are the first cases to be reported after relatively mild courses of COVID-19 and highlight the importance of including COVID-19 in the differential for Purtscher-like retinopathy.

The Role of Social Media in Strabismus Surgical Experience.

PURPOSE: To understand patients' strabismus surgery experience, including its impact on patients' appearance and psychosocial factors such as anxiety and depression, via trends on popular social media platforms. METHODS: TikTok and Instagram were searched for the following post hashtags: "#strabismus," "#strabismussurgery," "#crosseyed," and "#lazyeye." Data regarding date of post, username, gender, city, state, United States or international location, surgical status (preoperative, perioperative, or postoperative), tone (positive or negative), place of treatment, type of post (photo or video), number of likes/views, and number of followers were recorded for statistical analysis. RESULTS: A total of 790 posts (400 TikTok, 390 Instagram) were included. The majority (87.8%) had a positive tone, particularly for Instagram (Instagram = 97.7%, TikTok = 78.3%, P < .01). TikTok had significantly more likes/follower (P < .01), as did negative posts (P < .01). #Lazyeye gained significantly more traction than other hashtags (range: P < .001 to .006). There were no differences in likes/follower for treatment phase (preoperative/perioperative/postoperative), gender, or relative age of poster (adult/parent/child). CONCLUSIONS: These findings demonstrated that TikTok and Instagram users tend to share positive strabismus surgical experiences; however, negative posts were associated with more interactive responses from viewers. Colloquial hashtags (eg, #lazyeye) were more likely to gain traction than medical terms. TikTok posts were associated with more engagement than Instagram, which suggests TikTok may be a better platform going forward for patient outreach. [J Pediatr Ophthalmol Strabismus. 2023;60(6):402-405.].

Outcomes of Pars Plana Vitrectomy with Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy Without Retinal Detachment: A Seven-Year Retrospective Study.

Objective: To review clinical outcomes of patients with proliferative diabetic retinopathy (PDR) and vitreous hemorrhage (VH) who underwent pars plana vitrectomy (PPV) with endolaser panretinal photocoagulation (PRP) without retinal detachment (RD) repair. Methods: Retrospective chart review of the rate of postoperative clinical findings and visual acuity in patients with PDR from May 2014 to August 2021. Results: Pars plana vitrectomy with endolaser PRP was performed in 81 eyes of 81 patients (mean age of 62.1 ± 10.5 years). At a median follow-up of 18 months, mean Snellen best-corrected visual acuity (BCVA) significantly improved from 20/774 preoperatively to 20/53 at last follow-up (P < 0.001). Postoperative complications and clinical findings included VH (12.3%), diabetic macular edema (DME) (12.3%), ocular hypertension (8.6%), RD (4.9%), and need for additional PPV (6.2%). Eyes with PRP performed within 6 months before surgery had a lower frequency of developing postoperative VH (5.3%) compared to eyes that received PRP more than 6 months before surgery (27.3%, P = 0.04). Eyes that received preoperative anti-vascular endothelial growth factor (VEGF) treatment (2.0%) had a lower frequency of postoperative VH compared to eyes that did not receive anti-VEGF treatment (14.3%, P = 0.04). Eyes that received intraoperative sub-tenon triamcinolone acetonide developed postoperative DME (4.0%) less frequently than eyes that did not receive sub-tenon triamcinolone acetonide (26.7%, P = 0.04). Conclusion: In patients with PDR and VH, PPV with PRP yielded significant improvements in visual acuity and resulted in overall low rates of recurrent postoperative VH. Preoperative anti-VEGF and PRP laser treatment were associated with lower rates of postoperative VH. Furthermore, intraoperative use of sub-tenon triamcinolone acetonide was associated with a lower rate of postoperative DME. Pars plana vitrectomy with endolaser PRP in conjunction with the aforementioned pre- and intraoperative therapies is an effective treatment for patients with PDR and VH.

Effect of the SARS-CoV-2 Pandemic on Authorship Gender Disparities in the Ophthalmology Literature.

Background Studies in several fields of medicine have found that women published less during the COVID-19 pandemic, potentially due to an increase in domestic responsibilities. This study examines whether a similar pattern exists for female authorship in ophthalmology. Purpose To compare the proportions of female authorship published in high-impact ophthalmology journals before and during the COVID-19 pandemic. Methods A cross-sectional study analyzing authorship gender of articles published during the COVID-19 pandemic (between July and September 2020) compared with matched articles published in the same journals before the COVID-19 pandemic (between July and September 2019). Gender of the first and last authors was analyzed using an online gender determination tool. Results A total of 577 articles and 1,113 authors were analyzed. There was no significant difference in the average number of publications by male and female authors before and during the COVID-19 pandemic. There was a significant increase in the percentage of female first authorship from the prepandemic period (32%) to during the COVID-19 pandemic (40%; p = 0.01), but no significant increase in the last authorship ( p > 0.05). When analyzing only research articles, a similar increase in female first authorship was noted when comparing the publications before (31%) and during the COVID-19 pandemic (43%; p = 0.02). No significant differences were noted when analyzing the editorials ( p > 0.05). Conclusion While disparities continue to exist between male and female authorship, an increase in female first authorship was noted during the COVID-19 pandemic for overall articles as well as research articles. Precis During the COVID-19 pandemic, female authorship as first and last authors of peer-reviewed articles in high-impact ophthalmology journals was below 50%. However, while the overall rates of female authorship were unchanged, female first authorship significantly increased during the pandemic. These results differ from studies published in other medical fields that demonstrated a decrease in female authorship during the COVID-19 pandemic.

Authorship Gender Composition in Urology Literature From 2015 Through 2020.

OBJECTIVE: To describe the current landscape of first and last female authorship in urology journals relative to the journals' impact factor. We hypothesized that women would have a smaller proportion of publications in journals with higher impact factors. METHODS: Eighteen urology journals were divided into groups based on impact factor accordingly: from 33.2 to 6.2 were classified as high (European Urology, Nature Reviews Urology, The Journal of Urology, BJU International, Prostate Cancer and Prostatic Diseases, and The Journal of Sexual Medicine), from 5.8 to 5.0 as medium (Asian Journal of Andrology, European Urology Focus, Sexual Medicine Reviews, Bladder Cancer, Prostate and World Journal of Urology), and from 4.8 to 2.2 as low (Urologic Oncology, Journal of Endourology, Neurourology and Urodynamics, Urology, Journal of Pediatric Urology and Female Pelvic Medicine & Reconstructive Surgery). A computer script was designed using Python to search PubMed and record first and last author of publications between 2015 and 2020. Gender was determined by Gender-Api (https://gender-api.com). Names with an accuracy of <90% were excluded. Type of peer-review and scope of each journal were also analyzed. Statistical analysis was performed using Matlab. RESULTS: A total of 37,413 first and 28,414 last authors were identified during the study period. Overall, women represented 21% (8,029/37,413) of first and 15% (4,232/28,414) of last authors. Women were significantly less published in high impact journals compared to both medium and low impact journals (P <.001 in all). Among all journals, articles with female first authors were more likely to have a female last author (OR: 2.72, CI: 2.5-2.9, P <.001). Subspecialty journals had more female last authors than general journals (P <.05), and female representation increased if reviews were double-blinded (P <.001). Over the last 6 years, there has been a significant increase in female senior authorship among all journals (P = .045). CONCLUSION: The proportion of female authorship was significantly lower in higher impact urology journals. While the underlying cause is likely multifactorial, this finding highlights a gender discrepancy that may impact women's ability to achieve career goals in academic medicine when compared to their male counterparts.

Paradoxical Exudative Retinopathy and Macular Star Formation After Treatment Initiation in Coats Disease.

Purpose: This work describes a unique clinical feature in Coats disease. Methods: A retrospective series of 2 cases is reported. Results: Two pediatric patients receiving treatment for Coats disease were included. In both cases, vision worsened secondary to paradoxically increased exudation and macular star formation following standard treatment with intravitreal bevacizumab, sub-Tenon triamcinolone acetonide, and laser photocoagulation. After serial treatments under general anesthesia, the exudates in both cases consolidated. Conclusions: A paradoxical exudative retinopathy can occur in some patients when initiating standard treatment of Coats disease. Longitudinal follow-up with continued intravitreal antivascular endothelial growth factor agents, laser photocoagulation, and corticosteroids might help control persistent exudation in these cases.

The Effect of Market Competition on the Price of Topical Eye Drops.

PURPOSE: To describe the relationship between the number of Federal Drug Administration (FDA)-approved manufacturers and the price change of generic and branded topical eye drops. METHODS: Retrospective analysis of topical eye drop medications with formulations listed in the FDA Orange Book and the National Average Drug Acquisition Cost database from 2013 to 2017. RESULTS: The most frequently prescribed generic topical drugs were glaucoma medications (34%), antimicrobials (32%), anti-inflammatories (24%), mydriatics (5%), and anesthetics (5%). The most frequently prescribed branded topical drugs were anti-inflammatories (45%), glaucoma medications (32%), antimicrobials (21%) and dry eye medications (3%). From 2013 to 2017, generic eye drops had a median price decrease of 20% (IQR 32%) while branded eye drops had a median price increase of 44% (IQR 28%) (P < .001). A significant inverse association was identified between the price change of generic eye drops and the total number of all manufacturers (r = -.41, P = .010), generic drug manufacturers (r = -.32, P = .0496), and alternative branded drug manufacturers (r = -.57, P = .002). There was no significant association between the price change of branded eye drops and number of manufacturers. Glaucoma (r = -.58, P = .039) and anti-inflammatory (r = -.69, P = .047) eye drops also had significant inverse associations with the number of generic manufacturers. CONCLUSION: From 2013 to 2017, the price of generic eye drops decreased whereas the price of branded eye drops increased. Market competition was significantly inversely associated with price changes of generic eye drops but not branded eye drops.

Single-Blind and Double-Blind Peer Review: Effects on National Representation.

PURPOSE: To assess whether the type of peer-review (single-blinded vs double-blinded) has an impact on nationality representation in journals. METHODS: A cross-sectional study analyzing the top 10 nationalities contributing to the number of articles across 16 ophthalmology journals. RESULTS: There was no difference in the percentage of articles published from the journal's country of origin between the top single-blind journals and double-blind journals (SB = 42.0%, DB = 26.6%, p = .49), but there was a significant difference between the percentage of articles from the US (SB = 48.0%, DB = 22.8%, p = .02). However, there was no difference for both country of origin (SB = 38.0%, DB = 26.6%, p = .43) and articles from the US (SB = 35.0%, DB = 22.8%, p = .21) when assessing the top eight double-blind journals matched with single-blind journals of a similar impact factor. The US (n = 16, 100%) and England (n = 16, 100%) most commonly made the top 10 lists for article contribution. This held true even for journals established outside the United States (US=11/12, England = 11/12). CONCLUSIONS: There was no significant difference in country-of-origin representation between single-blind journals and double-blind journals. However, higher income countries contributed most often to the journals studied even among journals based outside the US.

Choroidal calcifications in two cases of aplasia cutis congenita and oculoectodermal syndrome.

PURPOSE: To describe choroidal calcifications as an ophthalmic feature in aplasia cutis congenita (ACC) with oculoectodermal syndrome (OES). OBSERVATIONS: Two cases of ACC/OES with characteristic echographic evidence of choroidal calcifications are described. CONCLUSIONS AND IMPORTANCE: The ophthalmic manifestations of ACC/OES may be expanded to include choroidal calcifications. The presence of a choroidal calcification with B-scan ultrasound in a case suspicious for ACC/OES may facilitate a more timely diagnosis and inform future follow-up regimens to monitor ophthalmic and systemic manifestations of this disease.

Ocular manifestations of Beckwith-Wiedemann syndrome.

Beckwith-Wiedemann syndrome (BWS; OMIM #130650) is a pediatric overgrowth disorder with few known ocular manifestations. We retrospectively reviewed the medical records of patients with BWS evaluated at Bascom Palmer Eye Institute over a 10-year period and identified 5 patients, of whom 4 presented with ocular misalignment and 1 with eye rubbing. Three patients were noted to have strabismus, and 1 patient manifested with significant astigmatism. No patients received surgical intervention.

Optical coherence tomography angiography and multimodal imaging in the management of coats' disease.

PURPOSE: To illustrate the spectrum of clinical and imaging features in patients with unilateral Coats' disease at baseline and in response to treatment with laser, intravitreal bevacizumab, and regional steroids. OBSERVATIONS: Telangiectasias, macular exudates, and vascular leakage were present in all 3 patients included in this series. After treatment with laser and bevacizumab, OCT angiography findings included an anomalous foveal vascular loop and chorioretinal anastomoses. Choroidal flow voids appeared to improve after intravitreal bevaziumab and laser treatment in 2 patients with OCT angiography obtained at follow up. A-scan axial lengths in affected eyes were 1.5-1.8 mm smaller than fellow eyes. CONCLUSIONS AND IMPORTANCE: OCT angiography is a non-invasive tool that can be a useful adjunct to multimodal imaging studies in the management of Coats' disease. Improved vascular density following anti-VEGF injection suggests a possible role of the choroidal vasculature in this retinal vascular pathology.

A 5-Year Analysis of Physician-Industry Interactions, Physician Gender, and Anti-VEGF Use in US Ophthalmologists.

Purpose: To explore physician gender, industry payments, and prescribing habits of anti-vascular endothelial growth factor (VEGF) agents.Methods: Retrospective review of U.S. ophthalmologists prescribing and receiving industry payments for aflibercept and/or ranibizumab (brand anti-VEGF injections) between August 2013 to December 2017.Results: Men receiving industry payments were older and had longer post-residency experience than women (both P < .001). Men were more likely to receive industry payments (P = .01), receive >5 payments (P = .003), and receive payments totaling >$1000 (P = .008). Men administered more injections on average than women when receiving >3 industry payments (P < .001) or when receiving >$100 (P < .01). On multivariate analysis, years in practice, male gender, number of payments, and total value of payments were independent factors associated with the number of brand injections administered (all P < .001).Conclusions: A positive association between industry payments and brand anti-VEGF use was identified, however, causality was not determined. Gender bias may be present in physician-industry relationships.

Bilateral iPhone Gorilla Glass Intraocular Foreign Bodies in a Pediatric Patient.

A 13-year old male presented with bilateral intraocular foreign bodies (IOFBs) after a bullet struck his iPhone. The right eye vision was 20/50 and examination disclosed a limbal entry wound at 6:00, dense traumatic cataract, and vitreous hemorrhage. The left eye was 20/40 and an entry wound located roughly 4mm posterior to the limbus was noted. Fundoscopy revealed multiple refractile particles with pre-retinal and vitreous hemorrhage. CT scan demonstrated hyperdensities in the vitreous cavity bilaterally. Globe closure, cataract removal, vitrectomy, and endolaser were undertaken in the right eye, while only globe closure was performed in the left eye. On latest follow-up, the patient had 20/20 corrected vision without inflammation bilaterally. This case highlights challenges associated with the management of IOFBs of unknown material in a pediatric patient. A conservative approach led to full visual recovery, despite retained intraocular smartphone Gorilla glass.

Primary evisceration for neonatal endogenous endophthalmitis: A report of two cases.

PURPOSE: To present two cases of neonatal endophthalmitis with poor prognosis that were managed with primary evisceration. OBSERVATIONS: Case 1 is a 27-weeks' gestation neonate who developed Pseudomonas aeruginosa endophthalmitis complicated by globe rupture. Case 2 describes a 34-weeks' gestation neonate with Serratia marcescens endophthalmitis. Both patients had poor prognosis and thus underwent primary evisceration with good long-term cosmetic outcomes at 15 years and 17 months, respectively. CONCLUSIONS AND IMPORTANCE: Primary evisceration should be considered in neonates with endophthalmitis with a poor prognosis and can result in good long-term cosmesis.

Surgeon demographic and surgical volume trends in adult strabismus surgery in the United States.

PURPOSE: To explore the influence of career stage, gender, and age on procedural trends of surgeons performing strabismus surgery. METHODS: Data on ophthalmologists who performed strabismus surgery and on the Medicare beneficiaries who underwent surgery between 2012 and 2017 was retrieved from Medicare Provider Utilization and Payment Data. RESULTS: A total of 133 strabismus surgeons (78.9% male and 21.1% female) were reimbursed by Centers for Medicare and Medicaid Services for 10,598 strabismus procedures during the study period. The overall number of strabismus surgeries increased (P = 0.039) over time. Most surgeons were 50-59 years of age (n = 45 [33.8%]), with an average age of 54.5 ± 9.5 years. The number of services per physician did not differ by gender (85 ± 97 procedures/male surgeon and 60 ± 149 procedures/female surgeon [P = 0.13]). There was no difference in the gender proportion of physicians, with 0-9 post-fellowship years of experience (P = 0.32), but there were significantly more men with 10-19 (P = 0.003), 20-29 (P < 0.001), and 30-39 (P < 0.001) years of post-fellowship experience. There was no difference in the number of procedures performed between women and men 30-39 (P = 0.83) or 60-69 (P = 0.48) years of age; however, women 40-49 (P = 0.009) and 50-59 (P < 0.001) years of age performed significantly fewer procedures per surgeon than men. CONCLUSIONS: Women performed significantly fewer surgeries midcareer compared to their male counterparts.