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.
Status | Completed |
Enrollment | 500 |
Est. completion date | October 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Subjects will include clinic patients selected with priority for those with poor visual acuity and based on maintaining smooth clinic functioning. Subjects will be classified into those with or without ocular disease, high refractive error, AMD, cataract, optic nerve abnormality, corneal abnormality, uveitis, glaucoma, other retinal/choroid abnormality, amblyopia, or a specified other ocular disease. Patients with low vision will be oversampled in order to test within a large range of possible end points. All subjects will have the ability to understand and sign an informed consent form obtained prior to enrollment. Enrolled participants will range in age from 7 years to 90 years. EXCLUSION CRITERIA: Illiteracy (inability to identify letters of the Latin alphabet) Children younger than 7, due to cognitive inability to undergo specific tests and procedures required in the protocol. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Eye Institute (NEI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6. — View Citation
Johnson CA, Samuels SJ. Screening for glaucomatous visual field loss with frequency-doubling perimetry. Invest Ophthalmol Vis Sci. 1997 Feb;38(2):413-25. — View Citation