Mortality among patients with idiopathic intracranial hypertension enrolled in the IH Registry.

OBJECTIVE: To determine (1) if mortality among patients with idiopathic intracranial hypertension (IIH) enrolled in the Intracranial Hypertension Registry (IHR) is different from that of the general population of the United States and (2) what the leading underlying causes of death are among this cohort. METHODS: Mortality and underlying causes of death were ascertained from the National Death Index. Indirect standardization using age- and sex-specific nationwide all-cause and cause-specific mortality data extracted from the Centers for Disease Control and Prevention Wonder Online Database allowed for calculation of standardized mortality ratios (SMR). RESULTS: There were 47 deaths (96% female) among 1437 IHR participants that met inclusion criteria. The average age at death was 46 years (range, 20-95 years). Participants of the IHR experienced higher all-cause mortality than the general population (SMR, 1.5; 95% confidence interval [CI], 1.2-2.1). Suicide, accidents, and deaths from medical/surgical complications were the most common underlying causes, accounting for 43% of all deaths. When compared to the general population, the risk of suicide was over 6 times greater (SMR, 6.1; 95% CI, 2.9-12.7) and the risk of death from accidental overdose was over 3 times greater (SMR, 3.5; 95% CI, 1.6-7.7). The risk of suicide by overdose was over 15 times greater among the IHR cohort than in the general population (SMR, 15.3; 95% CI, 6.4-36.7). CONCLUSIONS: Patients with IIH in the IHR possess significantly increased risks of death from suicide and accidental overdose compared to the general population. Complications of medical/surgical treatments were also major contributors to mortality. Depression and disability were common among decedents. These findings should be interpreted with caution as the IHR database is likely subject to selection bias.

Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of non-arteritic ischemic optic neuropathy (NAION).

BACKGROUND: Ten patients with bilateral visual loss due to sequential non-arteritic ischemic optic neuropathy (NAION) underwent autologous Bone Marrow Derived Stem Cell (BMSC) therapy within the Stem Cell Ophthalmology Treatment Study (SCOTS). SCOTS is an Institutional Review Board approved clinical study utilizing autologous BMSC in the treatment of optic nerve and retinal diseases that meet inclusion criteria. METHODS: The average age of the patients treated was 69.8 years. The average duration of visual loss in eyes treated was 9.8 years and ranged from 1 to 35 years. Affected eyes were treated with either retrobulbar, subtenons and intravenous BMSC or, following vitrectomy, intra-optic nerve, subtenons and intravenous BMSC. The primary outcome was visual acuity as measured by Snellen or converted to LogMAR. RESULTS: Following therapy in SCOTS, 80% of patients experienced improvement in Snellen binocular vision (P=0.029) with 20% remaining stable; 73.6% of eyes treated gained vision (P=0.019) and 15.9% remained stable in the post-operative period. There was an average of 3.53 Snellen lines of vision improvement per eye with an average 22.74% and maximum 83.3% improvement in LogMAR acuity per eye. The average LogMAR change in treated eyes was a gain of 0.364 (P=0.0089). Improvements typically manifested no later than 6 months post procedure. CONCLUSIONS: The use of BMSC in the Stem Cell Ophthalmology Treatment Study achieved meaningful visual improvements in a significant percentage of the NAION patients reported. Improvements typically manifested no later than 6 months post-procedure. Duration of visual loss did not appear to affect the ability of the eyes to respond to treatment. Possible mechanisms by which visual improvement occurred may include BMSC paracrine secretion of proteins and hormones, transfer of mitochondria, release of messenger RNA or other compounds via exosomes or microvesicles and neuronal transdifferentiation of the stem cells.

Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow-derived stem cells in the treatment of Leber's hereditary optic neuropathy.

The Stem Cell Ophthalmology Treatment Study (SCOTS) is currently the largest-scale stem cell ophthalmology trial registered at ClinicalTrials.gov (identifier: NCT01920867). SCOTS utilizes autologous bone marrow-derived stem cells (BMSCs) to treat optic nerve and retinal diseases. Treatment approaches include a combination of retrobulbar, subtenon, intravitreal, intra-optic nerve, subretinal, and intravenous injection of autologous BMSCs according to the nature of the disease, the degree of visual loss, and any risk factors related to the treatments. Patients with Leber's hereditary optic neuropathy had visual acuity gains on the Early Treatment Diabetic Retinopathy Study (ETDRS) of up to 35 letters and Snellen acuity improvements from hand motion to 20/200 and from counting fingers to 20/100. Visual field improvements were noted. Macular and optic nerve head nerve fiber layer typically thickened. No serious complications were seen. The increases in visual acuity obtained in our study were encouraging and suggest that the use of autologous BMSCs as provided in SCOTS for ophthalmologic mitochondrial diseases including Leber's hereditary optic neuropathy may be a viable treatment option.

Stem Cell Ophthalmology Treatment Study (SCOTS): improvement in serpiginous choroidopathy following autologous bone marrow derived stem cell treatment.

We report results in a 77-year-old male patient with visual loss from long-standing serpiginous choroidopathy treated with bone marrow derived stem cells (BMSC) within the Stem Cell Ophthalmology Treatment Study (SCOTS). SCOTS is an Institutional Review Board approved clinical trial and the largest ophthalmology stem cell study registered at the National Institutes of Health to date (ClinicalTrials.gov Identifier: NCT01920867). Eight months after treatment by a combination of retrobulbar, subtenon, intravitreal and intravenous injection of BMSC, the patient's best corrected Snellen acuity improved from 20/80- to 20/60+1 in the right eye and from 20/50- to 20/20-3 in the left eye. The Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity continued to improve over the succeeding 8 months and the optical coherence tomography macular volume increased. The increases in visual acuity and macular volume are encouraging and suggest that the use of BMSC as provided in SCOTS may be a viable approach to treating serpiginous choroidopathy.

Breaking bad news: A communication competency for ophthalmology training programs.

As the ophthalmology accreditation system undergoes major changes, training programs must evaluate residents in the 6 core competencies, including appropriately communicating bad news. Although the literature is replete with recommendations for breaking bad news across various non-ophthalmology specialties, no formal training programs exist for ophthalmology. There are many valuable lessons to be learned from our colleagues regarding this important skill. We examine the historic basis for breaking bad news, explore current recommendations among other specialties, and then evaluate a pilot study in breaking bad news for ophthalmology residents. The results of this study are limited by a small number of residents at a single academic center. Future studies from multiple training programs should be conducted to further evaluate the need and efficacy of formal communication skills training in this area, as well as the generalizability of our pilot training program. If validated, this work could serve as a template for future ophthalmology resident training and evaluation in this core competency.

Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy.

We present the results from a patient with relapsing optic neuropathy treated within the Stem Cell Ophthalmology Treatment Study (SCOTS). SCOTS is an Institutional Review Board approved clinical trial and has become the largest ophthalmology stem cell study registered at the National Institutes of Health to date (www.clinicaltrials.gov Identifier NCT 01920867). SCOTS utilizes autologous bone marrow-derived stem cells (BMSCs) for treatment of retinal and optic nerve diseases. Pre-treatment and post-treatment comprehensive eye exams of a 54 year old female patient were performed both at the Florida Study Center, USA and at The Eye Center of Columbus, USA. As a consequence of a relapsing optic neuritis, the patient's previously normal visual acuity decreased to between 20/350 and 20/400 in the right eye and to 20/70 in the left eye. Significant visual field loss developed bilaterally. The patient underwent a right eye vitrectomy with injection of BMSCs into the optic nerve of the right eyeand retrobulbar, subtenon and intravitreal injection of BMSCs in the left eye. At 15 months after SCOTS treatment, the patient's visual acuity had improved to 20/150 in the right eye and 20/20 in the left eye. Bilateral visual fields improved markedly. Both macular thickness and fast retinal nerve fiber layer thickness were maximally improved at 3 and 6 months after SCOTS treatment. The patient also reduced her mycophenylate dose from 1,500 mg per day to 500 mg per day and required no steroid pulse therapy during the 15-month follow up.