Misc Flashcards
clinical trials - phase 0
subjects: humans
microdosing for safety
clinical trials - phase 1
subjects: healthy volunteers
safety, s/e, pharmacokinets and dynamics
clinical trials - phase 2
subjects: target patients
IIA dosing
IIb efficacy
clinical trails - phase 3
subjects: larger groups of paitents
Effectivenss vs gold standard (RCTS)
clinical trials - phase 4
subjects: target group
post-marketing survelliance and yellow card scheme
visual standards group 1 entitlement - VA
Best corrected VA in good lighting sufficient to read a vehicle registration plate at
20 metres (where the figures are 5cm wide)
The equivalent of this is approximately 6/9 and 6/12 Snellen VA
visual standards group 1 entitlement - binocular field
There should be no major binocular field defect: no more than 3 contiguous points
missed in
At least 120 degrees on the horizontal scale
And within 20 degrees above and below fixation in the vertical
The Esterman protocol is commonly used for binocular testing: uses a target
equivalent to the white Goldmann III4e setting
visual standards group 1 entitlement - diplopia
New diplopia is a contraindication
Diplopia must be controlled and the patient must have adapted
when to inform DVLA
The DVLA should be informed about significant visual loss in one eye even if the
other meets the standard for driving
visual standards group 2 entitlement
Best corrected VA at least 6/9 in the stronger eye
Best corrected VA no worse than 6/12 in the other eye
Uncorrected visual acuity must be at least 3/60 in both eyes
NB: one eye with VA less than 3/60 is a contraindication to driving lorries,
buses
Normal binocular field of vision
New onset diplopia is a contraindication
Diplopia must be controlled with prisms only (not with patching) and the
patient must have adapted
blind registration
Best corrected visual acuity is less than 3/60; or,
Best corrected visual acuity is between 6/60 and 3/60 with field constriction; or,
Best corrected visual acuity is between 6/18 and 6/60 with severe field constriction
pelli-robson test purpose
Measures contrast sensitivity
o Method: Uses a single, large letter size (20/60 optotype).
o Contrast Variation: Across different groups of letters.
pelli-robson test procedure
o Starting Point: Patients read letters starting from the highest contrast.
o Continue until unable to correctly read 2 or 3 letters in a group.
pelli-robson test scoring
o Basis: Based on the contrast of the last group where 2 or 3 letters were correctly read.
o Logarithmic Measure: The score represents the subject’s contrast sensitivity.
o Example: A score of 2 indicates the ability to read at least 2 out of 3 letters at a contrast level of 1%(100% contrast sensitivity or log10 2), signifying normal contrast sensitivity.
pelli-robson test interpretation
o Less than 1.5: Consistent with visual impairment.
o Less than 1.0: Represents visual disability.
photostress recovery testing
- Differentiate between vision loss caused by macular lesion/ ocular ischaemia versus optic neuropathy
- Patient with optic neuropathy have normal photostress recovery time
- The theory behind this is that resythesis of visual pigments is required by
photostress recovery testing abnormal time
o age macular degeneration
o central serous retinopathy
o diabetic retinopathy
o digitalis toxicity
photostress recovery testing method
o test the eye monocularly
o patient gazes into bright light 2-3 cm from the eye for 10 seconds
o as soon as light is removed, patient attempts to read the larger Snellen visual acuity line above the line representing the patient’s visual acuity prior to the bright light
o normal photostress recovery time is approximately 30 seconds or more
photostress maculopathy results
severe ocular ischaemia can have recovery times of 90-180 seconds
non-organic visual loss
o Spiraling, Crossing, Stacking of Isoptres on Goldmann Visual Field
o Clover leaf visual field defect on HVF 24-2
tests that do not rely on patients interpretation
o Swinging light test
o Optokinetic nystagmus drum response used to elicit optokinetic nystagmus ( smooth pursuit with refixation saccade)
* Mirror test: when distracting a patient by holding conversation, move a mirror across their field of vision. It is difficult for patient to avoid looking at their own reflection
ishihara plates
screening test for red-green colour deficiency.
o Protan: red
o Deutan: Greeen