SPARCS: Spaeth/Richman Contrast Sensitivity Test

• Sponsor: Wills Eye (Other)
• Overall Status: Completed
• CT.gov ID: NCT01300949
• Collaborator: Pfizer (Industry)
• Enrollment: 314
• Location: 1
• Arms: 3
• Actual Duration (Months): 51
• Patients Per Site Per Month: 6.2

Study Details

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	N/A

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
• 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.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: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 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 Names: 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 Names: 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 Names: 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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
• ClinicalTrials.gov Identifier: NCT01300949
• Other Study ID Numbers: 10-998
• First Posted: Feb 23, 2011
• Last Update Posted: Dec 11, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by George L. Spaeth MD, Principal Investigator, Wills Eye: Contrast Sensitivity; Pelli-Robson Test
• Additional relevant MeSH terms: Hypersensitivity

Study Results

Participant Flow

Arm/Group Title	Glaucoma	Controls	Age-Related Macular Degeneration (ARMD)
Arm/Group Description	154 glaucoma, ocular hypertension and glaucoma suspect patients	125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).	35 retina patients with age-related macular degeneration (ARMD)
Period Title: Overall Study
STARTED	154	125	35
COMPLETED	154	125	35
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Glaucoma	Controls	Age-Related Macular Degeneration (ARMD)	Total
Arm/Group Description	154 glaucoma, ocular hypertension and glaucoma suspect patients	125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).	35 retina patients with age-related macular degeneration (ARMD)	Total of all reporting groups
Overall Participants	154	125	35	314
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68	49	81	62
Sex: Female, Male (Count of Participants)
Female	80 51.9%	65 52%	17 48.6%	162 51.6%
Male	74 48.1%	60 48%	18 51.4%	152 48.4%
Region of Enrollment (participants) [Number]
United States	154 100%	125 100%	35 100%	314 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glaucoma	Controls	Age-Related Macular Degeneration (ARMD)
Arm/Group Description	154 glaucoma, ocular hypertension and glaucoma suspect patients Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background	125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract). Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background	35 retina patients with age-related macular degeneration (ARMD) Spaeth/Richman Contrast Sensitivity Test: internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes Pelli-Robson Contrast Sensitivity Chart: chart measuring central vision with black letters fading to white on a white background
Measure Participants	154	125	35
Mean (Standard Deviation) [units on a scale]	59.4 (15.3)	74.4 (5.0)	53.9 (19)

Adverse Events

Time Frame	duration of 1 eye exam, approximately 1 hour
Arm/Group Title	Glaucoma		Controls		Age-Related Macular Degeneration (ARMD)
Arm/Group Description	154 glaucoma, ocular hypertension and glaucoma suspect patients		125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).		35 retina patients with age-related macular degeneration (ARMD)
All Cause Mortality
	Glaucoma		Controls		Age-Related Macular Degeneration (ARMD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/125 (0%)		0/35 (0%)
Serious Adverse Events
	Glaucoma		Controls		Age-Related Macular Degeneration (ARMD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/125 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Glaucoma		Controls		Age-Related Macular Degeneration (ARMD)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/154 (0%)		0/125 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.