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The most common agents used to dilate the pupil are phenylephrine (2.5% in pediatrics or 10% in adults) and tropicamide (0.5% or 1%). While phenylephrine stimulates receptors that contract the dilator muscle of the pupil, [6] tropicamide blocks stimulation of the pupillary sphincter muscle to allow for relaxation. [7]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Ophthalmic drug administration is the administration of a drug to the eyes, most typically as an eye drop formulation. Topical formulations are used to combat a multitude of diseased states of the eye. These states may include bacterial infections, eye injury, glaucoma, and dry eye. [1]
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
ICH E6 includes details of only a minimum list of contents and no other regulation or guideline provides a comprehensive list of TMF content. As a result of the inconsistencies that were developing across the sector, an industry group comprising 7 members from the GCP-RMA (Good Clinical Practice Records Managers Association) decided to develop ...
A swinging-flashlight test may also be desirable if neurologic damage is suspected. The swinging-flashlight test is the most useful clinical test available to a general physician for the assessment of optic nerve anomalies. This test detects the afferent pupil defect, also referred to as the Marcus Gunn pupil. It is conducted in a semidarkened ...
This type of perimetry is the most commonly used in clinical practice, and in research trials where loss of visual field must be measured. [4] However, the sensitivity of white-on-white perimetry is low, and the variability is relatively high; as many as 25–50 percent of the photoreceptor cells may be lost before changes in visual field ...
small curved canula the size of a syringe needle used to introduce fluids or drugs into the nasolacrimal passage to test its patency or during surgery (dacrocystography, dacrocystectomy, dacryocystorhinostomy(DCR), etc. Lang's lacrimal dissector with scoop: for blunt dissections and cleaning during operations like dacryocystorhinostomy: Rougine