Glaucoma
Conditions
Keywords
Contrast Sensitivity, Pelli-Robson 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.
Interventions
DIAGNOSTIC_TESTSpaeth/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.
DIAGNOSTIC_TESTPelli-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.
Sponsors
Pfizer
Wills Eye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Sensitivity, Another Means of Testing Vision | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glaucoma 154 glaucoma, ocular hypertension and glaucoma suspect patients | 154 |
| Controls 125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract). | 125 |
| Age-Related Macular Degeneration (ARMD) 35 retina patients with age-related macular degeneration (ARMD) | 35 |
| Total | 314 |
Baseline characteristics
| Characteristic | Glaucoma | Controls | Age-Related Macular Degeneration (ARMD) | Total |
|---|---|---|---|---|
| Age, Continuous | 68 years | 49 years | 81 years | 62 years |
| Region of Enrollment United States | 154 participants | 125 participants | 35 participants | 314 participants |
| Sex: Female, Male Female | 80 Participants | 65 Participants | 17 Participants | 162 Participants |
| Sex: Female, Male Male | 74 Participants | 60 Participants | 18 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 125 | 0 / 35 |
| other Total, other adverse events | 0 / 154 | 0 / 125 | 0 / 35 |
| serious Total, serious adverse events | 0 / 154 | 0 / 125 | 0 / 35 |
Outcome results
Primary
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.
Time frame: duration of 1 eye exam, approximately 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glaucoma | Contrast Sensitivity, Another Means of Testing Vision | 59.4 units on a scale | Standard Deviation 15.3 |
| Controls | Contrast Sensitivity, Another Means of Testing Vision | 74.4 units on a scale | Standard Deviation 5 |
| Age-Related Macular Degeneration (ARMD) | Contrast Sensitivity, Another Means of Testing Vision | 53.9 units on a scale | Standard Deviation 19 |