Spaeth/Richman Contrast Sensitivity Test (SPARCS)

• ClinicalTrials.gov Identifier: NCT01300949
• Recruitment Status: Completed
• First Posted: February 23, 2011
• Results First Posted: November 8, 2018
• Last Update Posted: December 11, 2018
• Sponsor: Wills Eye
• Collaborator: Pfizer
• Information provided by (Responsible Party): George L. Spaeth MD, Wills Eye

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 disease	Intervention/treatment	Phase
Glaucoma	Diagnostic Test: Spaeth/Richman Contrast Sensitivity Test; Diagnostic Test: Pelli-Robson Contrast Sensitivity Chart	Not Applicable

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 (Clinical Trial)
• 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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test
• Actual Study Start Date: January 2010
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/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 Name: 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 Name: 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 Name: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Wills Eye Institute

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Wills Eye

Pfizer

Investigators

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

More Information

Publications of Results:

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.

• Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT01300949
• Other Study ID Numbers: 10-998
• First Posted: February 23, 2011
• Results First Posted: November 8, 2018
• Last Update Posted: December 11, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Multiple manuscripts have been published.

Keywords provided by George L. Spaeth MD, Wills Eye:

Contrast Sensitivity; Pelli-Robson Test

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases