A Novel Acuity Testing Method

NCT00013936 | Completed

• 2 other identifiers: 01013601-EI-0136
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vision Disorder

Keywords

Instrument Development; Psychophysical Methods; ETDRS; Computer-Based Methods; Validation Study; Visual Acuity; Vision Tests/Instrumentation; Psychophysics; Modified Binary Search; Visual Acuity Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Johnson CA, Samuels SJ. Screening for glaucomatous visual field loss with frequency-doubling perimetry. Invest Ophthalmol Vis Sci. 1997 Feb;38(2):413-25.

  PMID: 9040475 BACKGROUND

• 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.

  PMID: 7091289 BACKGROUND

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 3, 2001
• First Posted: April 4, 2001
• Study Start: March 1, 2001
• Study Completion: October 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-10

Locations

US (1)