SPARCS: Spaeth/Richman Contrast Sensitivity Test

Sponsor
Wills Eye (Other)
Overall Status
Completed
CT.gov ID
NCT01300949
Collaborator
Pfizer (Industry)
314
Enrollment
1
Location
3
Arms
51
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast sensitivity. The test, another way to measure vision, is performed on any standard computer with internet access. Patients will be tested with SPARCS and with the standard Pelli-Robson contrast test.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Spaeth/Richman Contrast Sensitivity Test
  • Diagnostic Test: Pelli-Robson Contrast Sensitivity Chart
N/A

Detailed Description

Contrast Sensitivity is another way to test vision. It uses black on a white background and minimally decreases the black (grey) until it blends with the white. The least amount of contrast (faint grey) seen translates into amount of vision. This new method of determining contrast sensitivity uses black and white vertical bars and does not require recognizing letters in the alphabet. It tests various areas of the visual field and central vision. The test takes approximately 3 minutes per eye.

Pelli-Robson is a commonly used contrast sensitivity test that uses black letters on a white background. The letter size stays the same, only the amount of black changes, becoming greyer, making letters hard to see. The test takes approximately 1 minute per eye.

Hypothesis: A method of determining contrast sensitivity that does not require letter recognition (as does the Pelli-Robson test) eliminates the barriers of literacy and pattern recognition, to permit a more valid determination of contrast sensitivity.

Patients will perform SPARCS and Pelli-Robson twice; once each with two separate observers for reproducibility and intra-observer reliability. The order of testing will be randomized to SPARCS, Pelli, Pelli, SPARCS or Pelli, SPARCS, SPARCS, Pelli.

Study Design

Study Type:
Interventional
Actual Enrollment :
314 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Contrast sensitivity, another means of testing vision, will be measured two ways for each participant. One method uses the Pelli-Robson Contrast Sensitivity Chart which is mounted on the wall, the other method uses a new computerized program called Spaeth/Richman Contrast Sensitivity Test also known as SPARCS.Contrast sensitivity, another means of testing vision, will be measured two ways for each participant. One method uses the Pelli-Robson Contrast Sensitivity Chart which is mounted on the wall, the other method uses a new computerized program called Spaeth/Richman Contrast Sensitivity Test also known as SPARCS.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Glaucoma

154 glaucoma, ocular hypertension and glaucoma suspect patients will have contrast sensitivity measured by Spaeth/Richman Contrast Sensitivity Test (SPARCS) and Pelli-Robson Contrast Sensitivity Chart.

Diagnostic Test: Spaeth/Richman Contrast Sensitivity Test
internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes that decrease in contrast by fading to a white background.
Other Names:
  • SPARCS
  • Diagnostic Test: Pelli-Robson Contrast Sensitivity Chart
    wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.

    Active Comparator: Controls

    125 patients with no eye diseases will have contrast sensitivity measured by Spaeth/Richman Contrast Sensitivity Test (SPARCS) and Pelli-Robson Contrast Sensitivity Chart. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).

    Diagnostic Test: Spaeth/Richman Contrast Sensitivity Test
    internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes that decrease in contrast by fading to a white background.
    Other Names:
  • SPARCS
  • Diagnostic Test: Pelli-Robson Contrast Sensitivity Chart
    wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.

    Active Comparator: Age-Related Macular Degeneration (ARMD)

    35 retina patients with age-related macular degeneration (ARMD) will have contrast sensitivity measured by Spaeth/Richman Contrast Sensitivity Test (SPARCS) and Pelli-Robson Contrast Sensitivity Chart.

    Diagnostic Test: Spaeth/Richman Contrast Sensitivity Test
    internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes that decrease in contrast by fading to a white background.
    Other Names:
  • SPARCS
  • Diagnostic Test: Pelli-Robson Contrast Sensitivity Chart
    wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.

    Outcome Measures

    Primary Outcome Measures

    1. Contrast Sensitivity, Another Means of Testing Vision [duration of 1 eye exam, approximately 1 hour]

      Contrast Sensitivity, a vision measurement, is performed with the Spaeth Richmond Contrast Sensitivity (SPARCS) test. This is a computerized measurement of vision in the central and peripheral fields using black and white stripes. Black stripes decrease in contrast becoming fainter and harder to see until they blend with the white background. Measurements are assessed in five areas of the visual field . Test results are reported for each area ranging from 0 to 20 (0 means can't see stripes; 20 means sees all stripes). Results from all 5 areas are added making the total SPARCS score range 0 - 100 where 0 means poor vision and 100 means best vision. The test takes an average of 3 minutes per eye. The eye not being tested is covered with a patch.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 yrs of age and older

    • able to provide fully informed consent

    70 controls (patients with no ocular disease affecting visual acuity or visual function), 10 from each decade of life: 20-30, 30-40, 40-50, 50-60, 60-70, 70-80, 80+.

    105 patients with ocular hypertension or any type of glaucoma (15 subjects per age decade). Glaucoma patients will not have macular degeneration or visual acuity affected by any function other than glaucoma.

    40 patients with macular degeneration: 10 with visual acuity 20/40 or better, 10 with visual acuity between 20/40 and 20/60, 10between 20/100 and 20/400, and 10 with 20/400 or worse.

    40 patients with cataracts: 10 with lens opacity 1+nuclear sclerosis, 10 with 2 + nuclear sclerosis, 10 with 3 + nuclear sclerosis, 10 with 4 + nuclear sclerosis.

    60 patients with refractive error: 10 with myopia -5 diopters or greater, 10 with myopia between -5 and -2.5, 10 with myopia between -2.5 and -0.5, 10 with myopia between -0.5 and 0.5, 10 with myopia between 0.5 and 2.5, and 10 with myopia > 2.5.

    Exclusion Criteria:
    • any other diseases affecting visual acuity

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Wills Eye InstitutePhiladelphiaPennsylvaniaUnited States19107

    Sponsors and Collaborators

    • Wills Eye
    • Pfizer

    Investigators

    • Principal Investigator: George L Spaeth, MD, Glaucoma Service, Wills Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George L. Spaeth MD, Principal Investigator, Wills Eye
    ClinicalTrials.gov Identifier:
    NCT01300949
    Other Study ID Numbers:
    • 10-998
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Dec 11, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by George L. Spaeth MD, Principal Investigator, Wills Eye
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleGlaucomaControlsAge-Related Macular Degeneration (ARMD)
    Arm/Group Description154 glaucoma, ocular hypertension and glaucoma suspect patients125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).35 retina patients with age-related macular degeneration (ARMD)
    Period Title: Overall Study
    STARTED15412535
    COMPLETED15412535
    NOT COMPLETED000

    Baseline Characteristics

    Arm/Group TitleGlaucomaControlsAge-Related Macular Degeneration (ARMD)Total
    Arm/Group Description154 glaucoma, ocular hypertension and glaucoma suspect patients125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).35 retina patients with age-related macular degeneration (ARMD)Total of all reporting groups
    Overall Participants15412535314
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    68
    49
    81
    62
    Sex: Female, Male (Count of Participants)
    Female
    80
    51.9%
    65
    52%
    17
    48.6%
    162
    51.6%
    Male
    74
    48.1%
    60
    48%
    18
    51.4%
    152
    48.4%
    Region of Enrollment (participants) [Number]
    United States
    154
    100%
    125
    100%
    35
    100%
    314
    100%

    Outcome Measures

    1. Primary Outcome
    TitleContrast Sensitivity, Another Means of Testing Vision
    DescriptionContrast Sensitivity, a vision measurement, is performed with the Spaeth Richmond Contrast Sensitivity (SPARCS) test. This is a computerized measurement of vision in the central and peripheral fields using black and white stripes. Black stripes decrease in contrast becoming fainter and harder to see until they blend with the white background. Measurements are assessed in five areas of the visual field . Test results are reported for each area ranging from 0 to 20 (0 means can't see stripes; 20 means sees all stripes). Results from all 5 areas are added making the total SPARCS score range 0 - 100 where 0 means poor vision and 100 means best vision. The test takes an average of 3 minutes per eye. The eye not being tested is covered with a patch.
    Time Frameduration of 1 eye exam, approximately 1 hour

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleGlaucomaControlsAge-Related Macular Degeneration (ARMD)
    Arm/Group Description154 glaucoma, ocular hypertension and glaucoma suspect patients Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract). Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background35 retina patients with age-related macular degeneration (ARMD) Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background
    Measure Participants15412535
    Mean (Standard Deviation) [units on a scale]
    59.4
    (15.3)
    74.4
    (5.0)
    53.9
    (19)

    Adverse Events

    Time Frameduration of 1 eye exam, approximately 1 hour
    Adverse Event Reporting Description
    Arm/Group TitleGlaucomaControlsAge-Related Macular Degeneration (ARMD)
    Arm/Group Description154 glaucoma, ocular hypertension and glaucoma suspect patients125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).35 retina patients with age-related macular degeneration (ARMD)
    All Cause Mortality
    GlaucomaControlsAge-Related Macular Degeneration (ARMD)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/154 (0%) 0/125 (0%) 0/35 (0%)
    Serious Adverse Events
    GlaucomaControlsAge-Related Macular Degeneration (ARMD)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/154 (0%) 0/125 (0%) 0/35 (0%)
    Other (Not Including Serious) Adverse Events
    GlaucomaControlsAge-Related Macular Degeneration (ARMD)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/154 (0%) 0/125 (0%) 0/35 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleGeorge L. Spaeth, MD
    OrganizationWills Eye Hospital
    Phone215-928-3123
    Emailgspaeth@willseye.org
    Responsible Party:
    George L. Spaeth MD, Principal Investigator, Wills Eye
    ClinicalTrials.gov Identifier:
    NCT01300949
    Other Study ID Numbers:
    • 10-998
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Dec 11, 2018
    Last Verified:
    Nov 1, 2018