Hirano T, Imai A, Kasamatsu H, Kakihara S, Toriyama Y, Murata T Assessment of diabetic retinopathy using two ultra-wide-field fundus imaging systems, the Clarus(R) and Optos systems. BMC Ophthalmol. 2018 Dec 20;18(1):332. doi: 10.1186/s12886-018-1011-z.
Price LD, Au S, Chong NV Optomap ultrawide field imaging identifies additional retinal abnormalities in patients with diabetic retinopathy. Clin Ophthalmol. 2015 Mar 24;9:527-31. doi: 10.2147/OPTH.S79448. eCollection 2015.
Rasmussen ML, Broe R, Frydkjaer-Olsen U, Olsen BS, Mortensen HB, Peto T, Grauslund J Comparison between Early Treatment Diabetic Retinopathy Study 7-field retinal photos and non-mydriatic, mydriatic and mydriatic steered widefield scanning laser ophthalmoscopy for assessment of diabetic retinopathy. J Diabetes Complications. 2015 Jan-Feb;29(1):99-104. doi: 10.1016/j.jdiacomp.2014.08.009. Epub 2014 Aug 28.
Silva PS, Cavallerano JD, Sun JK, Noble J, Aiello LM, Aiello LP Nonmydriatic ultrawide field retinal imaging compared with dilated standard 7-field 35-mm photography and retinal specialist examination for evaluation of diabetic retinopathy. Am J Ophthalmol. 2012 Sep;154(3):549-559.e2. doi: 10.1016/j.ajo.2012.03.019. Epub 2012 May 23.
Silva PS, Cavallerano JD, Sun JK, Soliman AZ, Aiello LM, Aiello LP Peripheral lesions identified by mydriatic ultrawide field imaging: distribution and potential impact on diabetic retinopathy severity. Ophthalmology. 2013 Dec;120(12):2587-2595. doi: 10.1016/j.ophtha.2013.05.004. Epub 2013 Jun 15.
Wessel MM, Nair N, Aaker GD, Ehrlich JR, D'Amico DJ, Kiss S Peripheral retinal ischaemia, as evaluated by ultra-widefield fluorescein angiography, is associated with diabetic macular oedema. Br J Ophthalmol. 2012 May;96(5):694-8. doi: 10.1136/bjophthalmol-2011-300774. Epub 2012 Mar 15.
World Medical Association . World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373-4. Epub 2003 Jul 2. No abstract available.
Diabetic Retinopathy Classification: ETDRS 7-fields vs Widefield Imaging (Clarus 500 and Optos California)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.