Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02627339
Status:
COMPLETED
Last Update Posted:
2016-11-21
First Post:
2015-12-08
Brief Title:
Building a Database of Results From People Without Eye Problems
Sponsor:
Wills Eye
Organization:
Wills Eye
Study Overview
Official Title:
A Prospective Study of Controls to Build a Normative Database for the SpaethRichman Contrast Sensitivity Test SPARCS
Status:
COMPLETED
Status Verified Date:
2016-11
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:
SPARCS
Brief Summary:
The purpose of this study is to build a database of results from a new test that measures contrast sensitivity the Spaeth-Richman Contrast Sensitivity Test SPARCS Contrast sensitivity is an important part of your ability to see When contrast sensitivity decreases you are less able to see objects and detect motion For instance if you have decreased contrast sensitivity you might be less able to read see in the dark drive hit a ball or walk safely Decrease in contrast sensitivity leads to a decrease in quality of life
Detailed Description:
Objective To build a normative database for the Spaeth Richman Contrast Sensitivity Test SPARCS
Background Patients with glaucoma have diminished contrast sensitivity SPARCS is a novel test designed to determine the contrast threshold in the central 5 degrees of vision as well as each of the 4 peripheral quadrants superotemporal superonasal inferotemporal inferonasal It is performed on a standard computer with at least 1024 x 768 monitor resolution The correct testing distance is 50 cm away from the computer screen Appropriate refractive correction is used Testing is performed in a room with standardized lighting 85 cd m2 and no windows in order to minimize glare and reflections Testing is performed monocularly with the non-tested eye covered by an eye patch The purpose of this study is to build a normative database for SPARCS
Study Design Cross sectional observational study
Methods Healthy volunteers will be recruited from the Wills Eye Institute after obtaining informed consent following the principles of the Helsinki Convention Approximately 320 people free of ocular disease will be recruited to form a portion of the normative database for SPARCS A goal of 20 subjects per decade of life 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80 for both Caucasians and African Americans will be recruited Other ethnicities will also be recruited though without specific recruitment goals Future study locations will help diversify the population of the normative database
After agreeing to participate in the study subjects will be assessed to determine if they qualify Potential participants will be asked if they have any known eye diseases or decreased vision Best-corrected monocular visual acuities will be assessed using an ETDRS visual acuity chart A slit lamp examination will be performed to confirm good ocular health Subjects will be excluded if they have any apparent ocular disease that affects visual acuity or visual function For example people with glaucoma macular degeneration or diabetic retinopathy will be excluded Additional exclusion criteria includes visual acuity 2040 or worse cataract grade 2 3 or worse posterior capsular opacity grade 2 3 or worse refractive error greater than 5 or -5 diopters and incisional eye surgery within the prior 3 months
After a person qualifies for the normative database he or she will then take SPARCS A trained technician will position the patient to the correct testing distance check room lighting and then explain the test Subjects will be told to fixate on the central area and when ready click the central area once with a computer mouse Vertical dark bars will briefly appear in 1 of the 5 tested areas on the computer monitor A subject will then move the mouse to the area the image appeared and click it once When the subject is ready for the next image to appear he or she will click again on the central area Subjects are also instructed to guess where the image appeared if unsure Vertical square waves of varying contrast levels will then continue to appear in a random pattern until threshold has been reached for each area After the testing algorithm has been completed the test will automatically end
Each eye of an eligible subject will take the test twice after receiving instructions from a technician The technician will remain in the testing room the first two times SPARCS is taken A half hour later the subject will then take SPARCS again without instructions from the technician and without the technician being present in the room
The mean score and standard deviation of each area and the total score will be analyzed for age gender race and lens status Spearman correlations will be used to examine continuous variables and Kruskal-Wallis analysis for categorical measures Test-retest repeatability will be assessed using the Coefficient of Repeatability and the Intraclass Correlation Coefficient
Background Patients with glaucoma have diminished contrast sensitivity SPARCS is a novel test designed to determine the contrast threshold in the central 5 degrees of vision as well as each of the 4 peripheral quadrants superotemporal superonasal inferotemporal inferonasal It is performed on a standard computer with at least 1024 x 768 monitor resolution The correct testing distance is 50 cm away from the computer screen Appropriate refractive correction is used Testing is performed in a room with standardized lighting 85 cd m2 and no windows in order to minimize glare and reflections Testing is performed monocularly with the non-tested eye covered by an eye patch The purpose of this study is to build a normative database for SPARCS
Study Design Cross sectional observational study
Methods Healthy volunteers will be recruited from the Wills Eye Institute after obtaining informed consent following the principles of the Helsinki Convention Approximately 320 people free of ocular disease will be recruited to form a portion of the normative database for SPARCS A goal of 20 subjects per decade of life 10-19 20-29 30-39 40-49 50-59 60-69 70-79 80 for both Caucasians and African Americans will be recruited Other ethnicities will also be recruited though without specific recruitment goals Future study locations will help diversify the population of the normative database
After agreeing to participate in the study subjects will be assessed to determine if they qualify Potential participants will be asked if they have any known eye diseases or decreased vision Best-corrected monocular visual acuities will be assessed using an ETDRS visual acuity chart A slit lamp examination will be performed to confirm good ocular health Subjects will be excluded if they have any apparent ocular disease that affects visual acuity or visual function For example people with glaucoma macular degeneration or diabetic retinopathy will be excluded Additional exclusion criteria includes visual acuity 2040 or worse cataract grade 2 3 or worse posterior capsular opacity grade 2 3 or worse refractive error greater than 5 or -5 diopters and incisional eye surgery within the prior 3 months
After a person qualifies for the normative database he or she will then take SPARCS A trained technician will position the patient to the correct testing distance check room lighting and then explain the test Subjects will be told to fixate on the central area and when ready click the central area once with a computer mouse Vertical dark bars will briefly appear in 1 of the 5 tested areas on the computer monitor A subject will then move the mouse to the area the image appeared and click it once When the subject is ready for the next image to appear he or she will click again on the central area Subjects are also instructed to guess where the image appeared if unsure Vertical square waves of varying contrast levels will then continue to appear in a random pattern until threshold has been reached for each area After the testing algorithm has been completed the test will automatically end
Each eye of an eligible subject will take the test twice after receiving instructions from a technician The technician will remain in the testing room the first two times SPARCS is taken A half hour later the subject will then take SPARCS again without instructions from the technician and without the technician being present in the room
The mean score and standard deviation of each area and the total score will be analyzed for age gender race and lens status Spearman correlations will be used to examine continuous variables and Kruskal-Wallis analysis for categorical measures Test-retest repeatability will be assessed using the Coefficient of Repeatability and the Intraclass Correlation Coefficient
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