Going Beyond Gullstand

Are LASIK ablations good enough, or could they be improved by using more accurate individual-patient parameters? Arthur Cummings, MD, FRCS, believes outcomes can be made more accurate, and he notes that current ablations are based on the Gullstrand Eye model that assumes 43 D cornea and an axial length of 24 mm. “Irrespective of how sophisticated the data is that you’re going to use to drive the treatment, when you enter it into the laser, the laser thinks you are treating Gullstrand’s Eye,” Dr Cummings said.

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Implications for Ophthalmology of the Just-released FDA Draft Guidance on Imaging in Clinical Trials

Implications for Ophthalmology of the Just-released FDA Draft Guidance on Imaging in Clinical Trials

The evolution of diagnostic imaging technologies across medicine has been rapid, and a number of companies seeking approval for novel drugs and devices have been using and want to use imaging data as study endpoints in clinical trials. To assist these companies, the U.S. Food and Drug Administration (FDA) recently released a new draft guidance on the use of images in clinical trials. 

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