Abstract:
Importance:The US Food and Drug Administration's medical device regulatory pathway was initially conceived with hardware devices in mind. The emerging market for ophthalmic digital devices necessitates an evolution of this paradigm. Objectives:To facilitate innovation in ophthalmic digital health with attention to safety and effectiveness. Evidence Review:This article presents a summary of the presentations, discussions, and literature review that occurred during a joint Ophthalmic Digital Health workshop of the American Academy of Ophthalmology, the American Academy of Pediatrics, the American Association for Pediatric Ophthalmology and Strabismus, the American Society of Cataract and Refractive Surgery, the American Society of Retina Specialists, the Byers Eye Institute at Stanford and the US Food and Drug Administration. Findings:Criterion standards and expert graders are critically important in the evaluation of automated systems and telemedicine platforms. Training at all levels is important for the safe and effective operation of digital health devices. The risks associated with automation are substantially increased in rapidly progressive diseases. Cybersecurity and patient privacy warrant meticulous attention. Conclusions and Relevance:With appropriate attention to safety and effectiveness, digital health technology could improve screening and treatment of ophthalmic diseases and improve access to care.
journal_name
JAMA Ophthalmoljournal_title
JAMA ophthalmologyauthors
Bodnar ZM,Schuchard R,Myung D,Tarver ME,Blumenkranz MS,Afshari NA,Humayun MS,Morse C,Nischal K,Repka MX,Sprunger D,Trese M,Eydelman MBdoi
10.1001/jamaophthalmol.2019.1576subject
Has Abstractpub_date
2019-06-06 00:00:00eissn
2168-6165issn
2168-6173pii
2734823pub_type
杂志文章abstract:Importance:After long-duration spaceflight, morphological changes in the optic nerve head (ONH) and surrounding tissues have been reported. Objective:To develop methods to quantify ONH and surrounding tissue changes using preflight and postflight optical coherence tomographic scans of the ONH region. Design, Setting,...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2017.6226
更新日期:2018-02-01 00:00:00
abstract:Importance:To prevent blindness, repeated infant eye examinations are performed to detect severe retinopathy of prematurity (ROP), yet only a small fraction of those screened need treatment. Early individual risk stratification would improve screening timing and efficiency and potentially reduce the risk of blindness. ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2019.4502
更新日期:2019-11-07 00:00:00
abstract:Importance:Vitreoretinal lymphoma is a diagnostic challenge and the pathophysiology is still unclear. Objective:To describe an imaging finding seen on optical coherence tomography (OCT) of patients with vitreoretinal lymphoma. Design, Setting, and Participants:This case series study was a retrospective medical record...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2018.5835
更新日期:2019-02-01 00:00:00
abstract:IMPORTANCE:Tuberculosis is an endemic infectious disease in developing countries. Patients receiving treatment for systemic tuberculosis may develop paradoxical growth of tuberculomas in the brain, which can lead to vision loss. OBSERVATIONS:We describe 3 patients who had paradoxical development of tuberculomas in the...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2013.4840
更新日期:2013-11-01 00:00:00
abstract:Importance:Visual acuity (VA) outcomes differ considerably among patients with neovascular age-related macular degeneration (nAMD) treated with anti-vascular endothelial growth factor (VEGF) drugs. Identification of pharmacogenetic associations may help clinicians understand the mechanisms underlying this variability a...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaophthalmol.2018.2019
更新日期:2018-08-01 00:00:00
abstract:Importance:Adding a laser-induced chorioretinal anastomosis (L-CRA) to current treatments for central retinal vein occlusion (CRVO) may improve outcomes and lessen therapy burdens. Objective:To determine the 2-year efficacy of intravitreal ranibizumab with an L-CRA vs ranibizumab alone for patients with macular edema ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,随机对照试验
doi:10.1001/jamaophthalmol.2018.4973
更新日期:2018-12-01 00:00:00
abstract:Importance:The frequency of anti-vascular endothelial growth factor (VEGF) injections has grown exponentially with the introduction of bevacizumab, ranibizumab, and most recently aflibercept. The cost associated with these medications has garnered significant national attention, warranting a granular analysis of their ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2019.1971
更新日期:2019-06-20 00:00:00
abstract:Importance:Although almost equal numbers of male and female medical students enter into ophthalmology residency programs, whether they have similar surgical experiences during training is unclear. Objective:To determine differences for cataract surgery and total procedural volume between male and female residents duri...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2019.2427
更新日期:2019-07-18 00:00:00
abstract:Importance:Given the rarity of posterior uveal melanoma in patients younger than 21 years, reporting clinical experience in this area has relevance. Objective:To describe the baseline clinical features, treatment, and clinical course of a group of patients younger than 21 years who have primary posterior uveal melanom...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2018.5132
更新日期:2019-01-01 00:00:00
abstract:IMPORTANCE:African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. OBJECTIVE:To test the efficacy of behavioral act...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaophthalmol.2015.1760
更新日期:2015-09-01 00:00:00
abstract:IMPORTANCE:Visualization and interpretation of the optic nerve and retina are essential parts of most physical examinations. OBJECTIVE:To design and validate a smartphone-based retinal adapter enabling image capture and remote grading of the retina. DESIGN, SETTING, AND PARTICIPANTS:This validation study compared the...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2015.4625
更新日期:2016-02-01 00:00:00
abstract:Importance:The Diabetic Retinopathy Clinical Research Network Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR), with or without concomitant baseline diabetic macular ede...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaophthalmol.2017.0837
更新日期:2017-06-01 00:00:00
abstract:IMPORTANCE:Patching has been a mainstay in treating unilateral congenital cataract. However, its efficacy has not been rigorously assessed. OBJECTIVE:To examine the association between patching and visual acuity in a cohort of children treated for unilateral congenital cataract. DESIGN, SETTING, AND PARTICIPANTS:This...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaophthalmol.2016.1365
更新日期:2016-08-01 00:00:00
abstract:Importance:The ocular surface is continuously exposed to the environment. Although studies have focused on associations between outdoor environmental conditions and dry eye, information on associations between the indoor environment and dry eye is lacking. Objective:To determine associations between the indoor environ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2020.2237
更新日期:2020-08-01 00:00:00
abstract:Importance:Given the estimates of increasing prevalence of myopia, especially in Asia, it is important to determine the current prevalence of myopia among populations of schoolchildren in Japan. Objective:To investigate the current prevalence rate of myopia and the association between environmental factors and myopia ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2019.3103
更新日期:2019-08-15 00:00:00
abstract:Importance:The 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear. Objective:To compare treatment outcomes of ranibizumab, 0.5 ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2020.2443
更新日期:2020-09-01 00:00:00
abstract:IMPORTANCE:Few studies have been published on the association of the radiation dose received to the eyes during radiotherapy (RT) for childhood cancer and the risk for later cataract. OBJECTIVE:To investigate the risk for cataract after treatment of nonretinoblastoma solid cancer in childhood. DESIGN, SETTING, AND PA...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2015.6088
更新日期:2016-04-01 00:00:00
abstract:Importance:Some eyes with neovascular age-related macular degeneration (AMD) have persistent exudation despite frequent intravitreal anti-vascular endothelial growth factor (VEGF) injections. Adjuvant therapies that further reduce edema may improve vision outcomes. Objective:To compare the short-term effect of topical...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaophthalmol.2020.0724
更新日期:2020-05-01 00:00:00
abstract:IMPORTANCE:There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition. OBJECTIVE:To evaluate the efficacy of real relativ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaophthalmol.2013.5636
更新日期:2014-02-01 00:00:00
abstract:Importance:Congenital Zika syndrome (CZS) is known to be associated with severe malformations in newborns. Although microcephaly is the hallmark of this disease, the ocular findings are important given the severe visual impairment that has been observed in these patients. Regardless of the increased number of CZS cases...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2017.3595
更新日期:2017-11-01 00:00:00
abstract:Importance:There are limited published data on the phenotype of retinitis pigmentosa (RP) related to CNGB1 variants. These data are needed both for prognostic counseling of patients and for understanding potential treatment windows. Objective:To describe the detailed clinical and molecular genetic findings in a series...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2016.5213
更新日期:2017-02-01 00:00:00
abstract:IMPORTANCE:Myopia (nearsightedness) has its onset in childhood and affects about one-third of adults in the United States. Along with its high prevalence, myopia is expensive to correct and is associated with ocular diseases that include glaucoma and retinal detachment. OBJECTIVE:To determine the best set of predictor...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaophthalmol.2015.0471
更新日期:2015-06-01 00:00:00
abstract:Importance:Mobility limitations arising from vision impairment (VI) can result in loss of independence and reduced quality of life. However, few data are available on the association between VI and mobility limitations at a population-based level, particularly in Asian populations. Objective:To assess the association ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaophthalmol.2016.2394
更新日期:2016-10-01 00:00:00
abstract:Objective:To compare oral voriconazole with placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis. Design, Setting, and Participants:The Mycotic Ulcer Treatment Trial II (MUTT II), a multicenter, double-masked, placebo-controlled, randomized clinical trial, was conducted in India ...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1001/jamaophthalmol.2016.4096
更新日期:2016-12-01 00:00:00
abstract:IMPORTANCE:We conducted a series of phase 1 clinical trials to elucidate the efficacy and safety of the selective Rho kinase inhibitor K-115 as a candidate drug for the treatment of glaucoma. We report the intraocular pressure (IOP)-lowering effects and safety of K-115 based on our results. OBJECTIVE:To study the IOP-...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,随机对照试验
doi:10.1001/jamaophthalmol.2013.323
更新日期:2013-10-01 00:00:00
abstract:Importance:Although low-income populations have more eye problems, whether they face greater difficulty obtaining eye care appointments is unknown. Objective:To compare rates of obtaining eye care appointments and appointment wait times for those with Medicaid vs those with private insurance. Design, Setting, and Par...
journal_title:JAMA ophthalmology
pub_type: 杂志文章,多中心研究
doi:10.1001/jamaophthalmol.2018.0813
更新日期:2018-06-01 00:00:00
abstract:Importance:Identifying the course of glaucomatous visual field (VF) loss that progresses from normal to perimetric blindness is important for treatment and prognostication. Objective:To model the process of glaucomatous VF decay over the entire perimetric range from normal to perimetric blindness. Design, Setting, an...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2016.0118
更新日期:2016-05-01 00:00:00
abstract:IMPORTANCE:This study confirmed the long-term outcomes of the ZB5M phakic intraocular lens (PIOL). OBJECTIVE:To evaluate the potential long-term risk associated with ZB5M PIOL implantation. DESIGN, SETTING, AND PARTICIPANTS:A retrospective, nonrandomized, consecutive cohort study of a total of 208 eyes implanted with...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2013.5595
更新日期:2013-12-01 00:00:00
abstract:IMPORTANCE:Macular telangiectasia type 2 is a bilateral disease with characteristic alterations of the macular capillary network and neural atrophy. Vascular and neurodegenerative hypotheses have been proposed to explain these clinical findings, but many questions regarding the pathogenesis remain. OBSERVATIONS:We rep...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2015.1796
更新日期:2015-08-01 00:00:00
abstract:Importance:Most premature infants will not develop retinopathy of prematurity (ROP) of clinical relevance, yet screening evaluations often continue beyond hospital discharge, even for those infants without ROP. Objectives:To identify the characteristics of infants at low risk for ROP, for whom further postdischarge sc...
journal_title:JAMA ophthalmology
pub_type: 杂志文章
doi:10.1001/jamaophthalmol.2018.5520
更新日期:2019-02-01 00:00:00