- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300949
Spaeth/Richman Contrast Sensitivity Test (SPARCS)
Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Wills Eye Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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:
wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.
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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).
|
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:
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.
|
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:
wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Contrast Sensitivity, Another Means of Testing Vision
Time Frame: duration of 1 eye exam, approximately 1 hour
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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.
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duration of 1 eye exam, approximately 1 hour
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Collaborators and Investigators
Publications and helpful links
General Publications
- Richman J, Zangalli C, Lu L, Wizov SS, Spaeth E, Spaeth GL. The Spaeth/Richman contrast sensitivity test (SPARCS): design, reproducibility and ability to identify patients with glaucoma. Br J Ophthalmol. 2015 Jan;99(1):16-20. doi: 10.1136/bjophthalmol-2014-305223. Epub 2014 Jul 22.
- Faria BM, Duman F, Zheng CX, Waisbourd M, Gupta L, Ali M, Zangalli C, Lu L, Wizov SS, Spaeth E, Richman J, Spaeth GL. EVALUATING CONTRAST SENSITIVITY IN AGE-RELATED MACULAR DEGENERATION USING A NOVEL COMPUTER-BASED TEST, THE SPAETH/RICHMAN CONTRAST SENSITIVITY TEST. Retina. 2015 Jul;35(7):1465-73. doi: 10.1097/IAE.0000000000000474.
- Sun Y, Erdem E, Lyu A, Zangalli C, Wizov SS, Lo D, Spaeth EE, Richman J, Spaeth GL. The SPARCS: a novel assessment of contrast sensitivity and its reliability in patients with corrected refractive error. Br J Ophthalmol. 2016 Oct;100(10):1421-6. doi: 10.1136/bjophthalmol-2015-307378. Epub 2016 Jan 12.
- Gupta L, Cvintal V, Delvadia R, Sun Y, Erdem E, Zangalli C, Lu L, Wizov SS, Richman J, Spaeth E, Spaeth GL. SPARCS and Pelli-Robson contrast sensitivity testing in normal controls and patients with cataract. Eye (Lond). 2017 May;31(5):753-761. doi: 10.1038/eye.2016.319. Epub 2017 Jan 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-998
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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