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Spaeth/Richman Contrast Sensitivity Test (SPARCS)

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spaeth/Richman Contrast Sensitivity Test
Pelli-Robson Contrast Sensitivity Chart
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Contrast Sensitivity, Pelli-Robson Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wills Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Glaucoma

Controls

Age-Related Macular Degeneration (ARMD)

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Contrast Sensitivity, Another Means of Testing Vision
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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2011
Last Updated
November 16, 2018
Sponsor
Wills Eye
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01300949
Brief Title
Spaeth/Richman Contrast Sensitivity Test
Acronym
SPARCS
Official Title
Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Contrast Sensitivity, Pelli-Robson Test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Age-Related Macular Degeneration (ARMD)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spaeth/Richman Contrast Sensitivity Test
Other Intervention Name(s)
SPARCS
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pelli-Robson Contrast Sensitivity Chart
Intervention Description
wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.
Primary Outcome Measure Information:
Title
Contrast Sensitivity, Another Means of Testing Vision
Description
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.
Time Frame
duration of 1 eye exam, approximately 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L Spaeth, MD
Organizational Affiliation
Glaucoma Service, Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Multiple manuscripts have been published.
Citations:
PubMed Identifier
25053760
Citation
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.
Results Reference
result
PubMed Identifier
25658175
Citation
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.
Results Reference
result
PubMed Identifier
26758536
Citation
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.
Results Reference
result
PubMed Identifier
28106888
Citation
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.
Results Reference
result

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Spaeth/Richman Contrast Sensitivity Test

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