Abstract：
PURPOSE:We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. DESIGN:Cross-sectional study. METHODS:We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. RESULTS:Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P < .001). CONCLUSION:We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.
journal_name
Am J Ophthalmoljournal_title
American journal of ophthalmologyauthors
Khattab MH,Weaver M,Cook C,Kinder N,Vassar Mdoi
10.1016/j.ajo.2020.09.043subject
Has Abstractpub_date
2020-11-06 00:00:00pages
28-32eissn
0002-9394issn
1879-1891pii
S0002-9394(20)30552-3journal_volume
223pub_type
杂志文章abstract：PURPOSE:To report a case of primary systemic nonfamilial amyloidosis studied by fluorescein angiography and indocyanine green angiography. METHODS:Case report. A 59-year-old woman with primary systemic nonfamilial amyloidosis presented bilateral diffuse deep hemorrhages and pigmentary mottling at the posterior pole. ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(00)00506-7
更新日期：2000-08-01 00:00:00
abstract：PURPOSE:To compare three phacoemulsification machines for measurement accuracy and postocclusion surge (POS) in human cadaver eyes. DESIGN:In vitro comparisons of machine accuracy and POS. METHODS:Tip vacuum and flow were compared with machine indicated vacuum and flow. All machines were placed in two human cadaver e...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2008.01.024
更新日期：2008-06-01 00:00:00
abstract：PURPOSE:To assess the risks of vitrectomy for the removal of primary and secondary vitreous opacities. DESIGN:Retrospective, nonrandomized, interventional case series. METHODS:We reviewed the results of 116 consecutive cases of vitrectomy for vitreous floaters. Eighty-six cases were primary and 30 cases were secondar...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2011.01.005
更新日期：2011-06-01 00:00:00
abstract：PURPOSE:To document a branch retinal vein obstruction secondary to a congenital arteriovenous communication. METHOD:Case report of a young patient with retinal arteriovenous communication. RESULTS:A 12-year-old girl had a grade 2 retinal arteriovenous communication in her right eye. She was asymptomatic and was subse...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(98)00103-2
更新日期：1998-09-01 00:00:00
abstract：:Beta-aminopropionitrile, an inhibitor of collagen cross-linking, effectively limited the degree of posttraumatic vitreous proliferation in rabbits three weeks after double perforating injury. Light microscopic examination of the sites of perforating injury after five weeks showed minimal intravitreal fibrous prolifera...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(83)90337-9
更新日期：1983-01-01 00:00:00
abstract：PURPOSE:To report a rare presentation of the tubulointerstitial nephritis and uveitis syndrome. METHOD:Case report. A 34-year-old woman underwent extensive clinical and laboratory evaluation of bilateral intermediate uveitis and optic nerve edema. RESULTS:Laboratory evaluation and nephrology consultation led to a dia...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(98)00430-9
更新日期：1999-05-01 00:00:00
abstract：:A patient, initially examined at the age of 16 years and monitored for almost two decades, had corneal warpage and keratoconus associated with contact lens wear. Although the patient was advised repeatedly of the risk of continued contact lens use, she persisted. Contact-lens corrected visual acuity continued to deter...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(85)90678-6
更新日期：1985-10-15 00:00:00
abstract：PURPOSE:To determine if topical dorzolamide, as observed with the use of systemic acetazolamide and methazolamide, would be effective in treating cystoid macular edema (CME) in patients with retinitis pigmentosa (RP). DESIGN:Prospective, nonrandomized clinical trial. METHODS:setting: Institutional. patients: Fifteen ...
journal_title：American journal of ophthalmology
pub_type： 临床试验,杂志文章
doi：10.1016/j.ajo.2005.12.030
更新日期：2006-05-01 00:00:00
abstract：PURPOSE:To describe a novel imaging technique, which we call "dense B-scan optical coherence tomography angiography" (DB OCTA), in which thin dense raster scans are used to produce highly resolved structural B-scans with superimposed flow signal that provide precise correlation between retinal microstructure and blood ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2018.03.029
更新日期：2018-06-01 00:00:00
abstract：:Forty-three patients who initially presented with Krikenberg's spindles but with no glaucomatous field defects were observed for an average of 5.8 years in an attempt to evaluate the prognostic implication of spindle presence. Twenty-two of the patients had been followed for a minimum of five years. Analysis of the st...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(75)90075-6
更新日期：1975-02-01 00:00:00
abstract：PURPOSE:To evaluate a novel Zernike algorithm to differentiate 3-dimensional (3-D) corneal thickness distribution of corneas with keratoconus (KC) from normal corneas. DESIGN:A retrospective development and evaluation of a diagnostic approach. METHODS:Corneal tomography with Scheimpflug imaging was performed in norma...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2015.06.001
更新日期：2015-09-01 00:00:00
abstract：PURPOSE:To investigate the effect of cataract surgery on the concentration of moxifloxacin in aqueous and vitreous humor after topical application. DESIGN:Prospective laboratory intervention using a rabbit model. METHODS:Following topical administration of 0.5% moxifloxacin, 60 minutes before surgery and immediately ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2004.05.011
更新日期：2004-10-01 00:00:00
abstract：PURPOSE:To assess the long-term stability of sutured scleral-fixated posterior chamber intraocular lenses (PCIOLs) performed in combination with pars plana vitrectomy. DESIGN:Retrospective, consecutive, interventional case series. METHODS:Retrospective single-surgeon study of 118 eyes of 111 patients seen at Retina C...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2018.01.034
更新日期：2018-05-01 00:00:00
abstract：:We compared the intraocular pressure in 150 urban household contacts of patients with Hansen's disease and 132 endemic control subjects from an urban population in Karachi, Pakistan, who were matched in regard to race, age, gender, and socioeconomic status. The mean intraocular pressure in the upright position was 12....
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(14)71861-6
更新日期：1992-10-15 00:00:00
abstract：:Two patients had ocular myasthenia gravis coexistent with Hashimoto's thyroiditis. A 37-year-old woman presented with diplopia and displayed a head tremor and thyroid enlargement. Thyroid function tests showed an elevated thyroid stimulating hormone (TSH). A quantitative Tensilon test yeilded a "perverse" response and...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(75)90691-1
更新日期：1975-06-01 00:00:00
abstract：:We used a technique for surgical management of fibrovascular membranes to relieve epiretinal tangential traction when present in proliferative diabetic retinopathy. Sharp dissection with intraocular scissors was used to segment fibrovascular and cortical vitreous membranes together with cauterization of large vessels ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(80)90012-4
更新日期：1980-03-01 00:00:00
abstract：PURPOSE:To determine whether central corneal thickness (CCT) is a risk factor for visual field loss development among patients diagnosed with preperimetric glaucomatous optic neuropathy (GON). DESIGN:Observational cohort study. METHODS:The study included 98 eyes of 98 patients with GON, with a mean follow-up time of ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(03)00484-7
更新日期：2003-11-01 00:00:00
abstract：:Thirty-six patients who had clinically progressive Graves' dysthyroid orbitopathy were treated with supervoltage orbital radiotherapy. Twenty-three of the patients had discontinued the use of orally administered prednisone after developing intolerable side effects. Medical contraindications prevented seven patients fr...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(14)76158-6
更新日期：1992-04-15 00:00:00
abstract：:We undertook an in vitro investigation of the role of the design of the eyedrop dispenser in bacterial contamination. The nozzle tips of pipette and squeeze bottles containing Fluress (pH 5.0) were inoculated with 10 microliter of an ocular isolate of Pseudomonas aeruginosa (5.5 X 10(5) bacteria/ml). Cultures of singl...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(84)90238-1
更新日期：1984-11-01 00:00:00
abstract：:Amyloid was identified by light and electron microscopy within corneal grafts of two male siblings from a family with lattice corneal dystrophy type 1. These deposits indicate a recurrent disease within the donor tissue, and we believe this reflects an infiltration of the grafts by genetically abnormal host corneal fi...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(82)90251-3
更新日期：1982-10-01 00:00:00
abstract：:A clinical study of eyes with rhegmatogenous retinal detachment compared the reattachment rate in two groups of eyes: in the control group, cryopexy was applied over the retinal breaks during surgery; in the test group, cryopexy was not applied. There was a similar rate of retinal reattachment in the two groups in the...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(81)90235-x
更新日期：1981-04-01 00:00:00
abstract：PURPOSE:To evaluate the natural history and ophthalmologic morbidity of Mycoplasma pneumoniae-induced rash and mucositis (MIRM) and propose a treatment algorithm. DESIGN:Retrospective, interventional case series. METHODS:Retrospective chart review of all MIRM patients examined by the department of ophthalmology at a ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2020.06.010
更新日期：2020-11-01 00:00:00
abstract：PURPOSE:To determine whether alterations of p53, a tumor suppressor gene, were present in uveal melanoma, and to characterize further the nature of those changes. METHODS:Immunohistochemical analysis with a monoclonal antibody was used to determine whether alterations of p53 were present in 35 enucleated archival uvea...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(14)75431-5
更新日期：1996-05-01 00:00:00
abstract：PURPOSE:To clinically validate and ascertain the repeatability of a short questionnaire for dry eye syndrome (DES), consisting of two questions pertaining to symptoms (dryness and irritation) and one question regarding previous history of clinically diagnosed DES. DESIGN:Clinical validation study with repeated assessm...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2006.02.038
更新日期：2006-07-01 00:00:00
abstract：PURPOSE:To conduct a qualitative description of corneal and glaucoma outcomes in Peters anomaly. DESIGN:Retrospective case series. METHODS:Children with Peters anomaly who presented between 1982-2017 were included. Visual acuity, intraocular pressure (IOP), survival of corneal grafts, and success of glaucoma surgery ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2019.08.012
更新日期：2019-12-01 00:00:00
abstract：:Topical ketoconazole (2% ointment three times per day for three weeks) markedly reduced the severity of keratitis produced with Candida albicans inoculation in the right eyes of 20 rabbits. Clinical scores of affected eyes were significantly lower in the treated eyes than in the controls, which consisted of the 20 ino...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/0002-9394(86)90084-x
更新日期：1986-10-15 00:00:00
abstract：PURPOSE:To investigate the spectrum of organisms causing culture-proven endophthalmitis and their susceptibilities to commonly used antimicrobial agents over 10 years. DESIGN:Retrospective, noncomparative, consecutive case series. METHODS:Medical records were reviewed of all cases with culture-proven endophthalmitis ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2013.01.027
更新日期：2013-07-01 00:00:00
abstract：PURPOSE:To compare wound characteristics and integrity of the 2.2-mm and 2.65-mm clear corneal incisions. DESIGN:Prospective, randomized clinical trial. METHODS:Patients undergoing phacoemulsification with lens implant were randomized to receive a 2.2-mm or 2.65-mm temporal clear corneal incision. The incisions were ...
journal_title：American journal of ophthalmology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.ajo.2009.12.008
更新日期：2010-05-01 00:00:00
abstract：PURPOSE:To describe a case of spontaneous retrobulbar hemorrhage in type IV Ehlers-Danlos syndrome, a disorder characterized by vascular fragility and associated severe bleeding problems. METHODS:Observational case report. Spontaneous unilateral retrobulbar hemorrhage in a 22-year-old man with type IV Ehlers-Danlos sy...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/s0002-9394(01)01325-3
更新日期：2002-03-01 00:00:00
abstract：PURPOSE:To report the prevalence rates of anisometropia in a school population and determine the relative contribution of refractive power and axial length to the measured anisometropia. DESIGN:Population-based cross-sectional study. METHODS:Autorefraction, keratometry, and ultrasonography studies were made. SETTING...
journal_title：American journal of ophthalmology
pub_type： 杂志文章
doi：10.1016/j.ajo.2003.10.028
更新日期：2004-03-01 00:00:00
