Trial Outcomes & Findings for Spaeth/Richman Contrast Sensitivity Test (NCT NCT01300949)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

314 participants

Primary outcome timeframe

duration of 1 eye exam, approximately 1 hour

Results posted on

2018-12-11

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spaeth/Richman Contrast Sensitivity Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glaucoma n=154 Participants 154 glaucoma, ocular hypertension and glaucoma suspect patients	Controls n=125 Participants 125 patients with no eye diseases. This included patients with refractive errors (needing glasses) and nuclear sclerosis (cataract).	Age-Related Macular Degeneration (ARMD) n=35 Participants 35 retina patients with age-related macular degeneration (ARMD)	Total n=314 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	49 years n=7 Participants	81 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	65 Participants n=7 Participants	17 Participants n=5 Participants	162 Participants n=4 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	60 Participants n=7 Participants	18 Participants n=5 Participants	152 Participants n=4 Participants
Region of Enrollment United States	154 participants n=5 Participants	125 participants n=7 Participants	35 participants n=5 Participants	314 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glaucoma n=154 Participants 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	Controls n=125 Participants 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	Age-Related Macular Degeneration (ARMD) n=35 Participants 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
Contrast Sensitivity, Another Means of Testing Vision	59.4 units on a scale Standard Deviation 15.3	74.4 units on a scale Standard Deviation 5.0	53.9 units on a scale Standard Deviation 19

Adverse Events

Glaucoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Age-Related Macular Degeneration (ARMD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George L. Spaeth, MD

Wills Eye Hospital

Phone: 215-928-3123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place