Vision Disorder Clinical Trial
Official title:
A Novel Acuity Testing Method
The purpose of this protocol is to develop a valid, reliable, better standardized, and more
efficient test of visual acuity (ability to see fine details) for use in clinical trials.
Recent improvements in computer video hardware permit calibration, characterization, and
accurate rendering of eye-chart-quality letters. The computer can then be used to measure
acuity. The modified binary search (MOBS) testing strategy is one method of computer-based
testing. This study will compare the accuracy, precision, stability and utility of the MOBS
technique with the eye chart method used in the National Eye Institute's Early Treatment for
Diabetic Retinopathy Study (ETDRS). The ETDRS method is currently the gold standard for
acuity testing in clinical trials.
Study subjects will include NEI clinic patients between 7 and 90 years of age with or
without eye disease. Eye diseases include poor visual acuity, age-related macular
degeneration, cataract, optic nerve abnormality, corneal abnormality, uveitis, glaucoma,
other retinal or choroid abnormality, amblyopia or other eye disease.
Participants will have their vision tested in each eye using both the ETDRS eye chart method
and the MOBS method. The ETDRS method will require subjects to read all the letters on the
chart until they can no longer see the details. For the MOBS method, they will read a single
letter at a time that will appear on the computer screen. After reading each letter, a new
letter will be presented that is either bigger or smaller in size. After completing the last
acuity test, participants will fill out a questionnaire regarding their preference for one
test type over the other.
The primary objective of the project is to develop a valid, reliable, better standardized
and more efficient test of visual acuity for use in clinical trials. Accuracy, precision,
stability, and utility of the test will be assessed for non-inferiority with Early Treatment
for Diabetic Retinopathy Study (ETDRS) protocol, the gold standard for acuity testing in
clinical trials.
The experimental protocol (EVA-MOBS {Electronic Visual Acuity - Modified Binary Search})
utilizes a testing strategy that would appear to increase the efficiency and standardization
of acuity threshold determination. A more efficient test is justified on the basis of
reducing subject burden. Increased measurement efficiency may also reduce both subject- and
tester-based bias, while allowing a better means to assess measurement stability through the
collection of repeated measures data.
As part of the standard eye examination, replicated visual acuity assessments will be made
during regularly-scheduled Clinic visits. Up to 500 opportunistically-sampled subjects from
the National Eye Institute will be tested both with the ETDRS and EVA-MOBS protocols over a
12 month study period. Similar testing will take place at two other institutions (Devers Eye
Institute, Portland, OR; The Retina Foundation of the Southwest, Dallas, TX) and the data
from all three institutions will be combined and analyzed at the JAEB Center (Tampa, FL).
Subjects will range in age from 7 years to 90 years and will be classified by clinical
diagnosis (normal, high refractive error, age-related macular degeneration, cataract, optic
nerve abnormality, corneal abnormality, uveitis, glaucoma, retinal/choroid abnormality,
amblyopia and other criteria). First, those with poor acuity will be oversampled by
increasing the chance that they will be selected for this testing. Second, patients will
only be selected for this extra testing if it will not seriously delay clinic operations on
any given day. Order of acuity test type will be randomized. It is estimated that up to 10
patients per day can have this testing performed without compromising clinic operations.
The experimental protocol runs on a Palm handheld that is used to provide instructions to
the tester, record the subject's responses, and communicate with a PC/monitor at a test
distance of 3 meters. Stimuli are high contrast black-and-white ETDRS letters presented on
an ultra high resolution FD Trinitron monitor, that subtend 2.5 to 200 min of arc; each
letter appears in isolation under equiluminant conditions, and is flanked with black bars to
simulate visual crowding.
Acuity scores will be compared, with the ETDRS score serving as the reference standard.
Stability of the acuity estimates from the EVA-MOBS protocol will be assessed with data from
repeated measures. A short questionnaire will be administered, following the last acuity
test, to determine whether a test type preference exists.
If results indicate that the protocol is well tolerated by clinical populations and that
thresholds are accurate, precise, and stable, the method will be standardized for use in
future trials. Use of stimuli to test visual resolution acuity, such as the Landolt-C, may
subsequently be evaluated.
;
N/A