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.

Refractive Outcomes of Combined Cataract Surgery and Vitrectomy Compared to Cataract Surgery Alone.

PURPOSE: The aim of the study was to evaluate the refractive outcomes of combined cataract surgery and vitrectomy compared to cataract surgery alone. METHODS: This retrospective chart review study included two groups: (1) combined surgery in 103 eyes (101 patients) who underwent cataract surgery with posterior chamber intraocular lens (PCIOL) placement by a single cataract surgeon and vitrectomy by a single vitreoretinal surgeon at the same surgical setting; (2) cataract surgery alone by the same surgeon in 107 eyes (84 patients). Refractive outcomes and complications between the combined and cataract surgery alone group were compared. The predicted refractive error was compared to postoperative refractive outcomes in both groups, surgically induced astigmatism (SIA), intraoperative or postoperative complications of either cataract surgery or vitrectomy, and cystoid macular edema. RESULTS: There was no statistically significant difference between predicted and actual postoperative refractive outcomes between the combined and cataract surgery alone groups (within ±0.5 diopters [D], p = 0.099; within ±1.0 D, p = 0.721). There was no difference in SIA refractive outcomes between the two groups (p = 0.509). The use of intraoperative gas for retina tamponade did not significantly affect postoperative refractive outcomes. Both cataract surgery and vitrectomy were successfully performed without unexpected complications from either procedure affecting the other. DISCUSSION/CONCLUSION: Combined cataract surgery and vitrectomy allows excellent refractive outcomes equal to cataract surgery alone, allowing each procedure to be performed independently by separate anterior and posterior segment surgeons. Combined procedures can be performed in eyes with a variety of retinal indications and can include fluid-gas exchange with minimal risk of PCIOL malposition or change in targeted refraction.

Spontaneous Resolution of a Choroidal Mass: A Case Series.

Choroidal masses can be of varying etiologies including tumors of benign, primary, and metastatic nature. Herein, we report on 3 cases of well-documented solitary choroidal masses associated with exudative retinal detachments of unclear etiology (despite extensive workup) that resolved spontaneously.

Assessing "Cell Therapy" Clinics Offering Treatments of Ocular Conditions using Direct-to-Consumer Marketing Websites in the United States.

PURPOSE: "Cell therapy" is becoming increasingly available to the public via online direct-to-consumer advertisement within the United States (U.S.). The current study investigates the scope of "cell therapy" clinics across the U.S. that advertise and offer "cell therapy" for ocular conditions based on information provided on their websites. DESIGN: Cross-sectional study. PARTICIPANTS: The study included companies that are U.S.-based, participate in direct-to-consumer online marketing, have websites that can be data-mined with content analysis, and advertise therapy for ocular conditions. METHODS: Using a systematic, extensive keyword-based Internet search, content analysis of company websites was utilized to identify, document, and analyze U.S. businesses marketing "cell therapy" for ocular conditions as of September 16, 2017. MAIN OUTCOME MEASURES: Clinic locations, source of stem cells used, route of administration, marketed ocular conditions, and cost of treatment. RESULTS: Forty companies with 76 clinics use "cell therapy" to treat ocular conditions. California (23), Florida (12), and Illinois (10) contain the most clinics. All 40 companies specified sources of cells, which included autologous adipose-derived stem cells (35; 67%), autologous bone marrow-derived stem cells (8; 15%), amniotic stem cells (2; 4%), peripheral blood-derived stem cells (2; 4%), umbilical cord blood stem cells (2; 4%), allogenic bone marrow-derived stem cells (1; 2%), placental stem cells (1; 2%), and xenocells (1; 2%). The most commonly marketed ocular conditions included macular degeneration (35), optic neuritis (18), retinitis pigmentosa (17), and diabetic retinopathy (16). The most common routes of administration were intravenous (22) and "unspecified" (12); however, other companies listed more ocular-specific routes such as intravitreal injections (2), retrobulbar injections (2), eye injections (2), retrofundal injection (1), sub-Tenon injection (1), intraocular injection with vitrectomy (1), and eye drops (1). The cost of advertised "cell therapy" ranged from $4000 to $10 500. CONCLUSIONS: "Cell therapy" for ocular conditions is readily available via direct-to-consumer marketing strategies across the United States. The "cells" are harvested from numerous sources and administered through different methods for multiple ocular conditions at these "cell therapy" clinics. Limited data for these treatments necessitates advocating caution to physicians and patients about treatments offered at commercial "cell therapy" clinics.

Polypoidal Choroidal Vasculopathy.

PURPOSE OF REVIEW: The goal of this paper is to review the recent literature of polypoidal choroidal vasculopathy (PCV) and provide an update on the epidemiology, pathophysiology, clinical findings, and management. RECENT FINDINGS: Although indocyanine-green angiography (ICGA) is still the gold standard for diagnosis of PCV, the use of en face optical coherence tomography (OCT) and OCT angiography are useful tools in the diagnosis of PCV. Studies demonstrate superior treatment outcomes with combination photodynamic therapy (PDT) and anti-vascular endothelial growth factor (VEGF) therapy. SUMMARY: PCV is a disease most commonly in Asians and African-Americans and presents with an orange-red nodule in the macula or the peripapillary region. While ICGA remains the most accurate method to diagnose PCV, newer non-invasive imaging modalities (eg. OCT-A and en face OCT) can be used to identify PCV lesions. The combination of PDT and anti-VEGF therapy is superior to either monotherapy. Future studies of OCT modalities and other anti-VEGF agents will be important in guiding PCV diagnosis and management, respectively.

Lanthanide complexes of the Kläui metalloligand, CpCo(P═O(OR)2)3: an examination of ligand exchange kinetics between isotopomers by electrospray mass spectrometry.

A series of lanthanide complexes, {[CpCo(P═O(OR)2)3]2Ln(H2O)x}(+)Cl(-) (Ln = Nd, 3; Eu, 4; Tb, 5; Yb, 6; R = Et, a; R = Ph, b) bearing two cobalt metalloligands were prepared. Electrospray mass spectrometry and thermogravimetric analysis suggest that the cations are either solvent-free or contain very weakly bound water molecules. The related complex {[CpCo(P═O(OPh)2)3]2Yb}(+) [CoCl3(THF)](-), 7, was crystallographically characterized, and the cation in this case was confirmed to be 6-coordinate and solvent-free. Ligand exchange rates between the d0- and d60-isotopomers of 3a-6a and 5b were determined in acetonitrile by electrospray mass spectrometry. The ligand exchange rate was found to increase by almost 4 orders of magnitude from the smallest (Yb, 6a, k = 0.3 M(-1) s(-1)) to largest ion (Nd, 3a, >2500 M(-1) s(-1)) in acetonitrile. Additionally, the ligand exchange rate increased rapidly for 5a (Tb) with increasing water concentration from 30 M(-1) s(-1) in pure acetonitrile to 268 M(-1) s(-1) in 50:50 (v/v) acetonitrile/water. Changing the phosphite substituent had no significant impact on the rate of ligand exchange for 5b (R = Ph) relative to 5a (R = Et).