Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013936
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-04-03
Brief Title:
A Novel Acuity Testing Method
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Novel Acuity Testing Method
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Institutes 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
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
Detailed Description:
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 retinalchoroid 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 subjects responses and communicate with a PCmonitor 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 25 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
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 retinalchoroid 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 subjects responses and communicate with a PCmonitor 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-EI-0136 | None | None | None |