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Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
- any other diseases affecting visual acuity
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Spaeth/Richman Contrast Sensitivity Test | ||||
| Official Title ICMJE | Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | 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 | ||||
| Condition ICMJE | Glaucoma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 314 | ||||
| Original Estimated Enrollment ICMJE | 315 | ||||
| Actual Study Completion Date ICMJE | April 2014 | ||||
| Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01300949 | ||||
| Other Study ID Numbers ICMJE | 10-998 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | George L. Spaeth MD, Wills Eye | ||||
| Study Sponsor ICMJE | Wills Eye | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| PRS Account | Wills Eye | ||||
| Verification Date | November 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||