Clinical trial NCT01300949: Spaeth/Richman Contrast Sensitivity Test
Official title: Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Contrast Sensitivity
Pelli-Robson Test
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-02-23
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Contrast Sensitivity, Another Means of Testing Vision
timeFrame: duration of 1 eye exam, approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Glaucoma Service, Wills Eye Institute
name: George L Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.