NCT01300949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

November 8, 2018

Completed
Last Updated

December 11, 2018

Status Verified

November 1, 2018

Enrollment Period

4.2 years

First QC Date

February 22, 2011

Results QC Date

November 22, 2017

Last Update Submit

November 16, 2018

Conditions

Keywords

Contrast SensitivityPelli-Robson Test

Outcome Measures

Primary Outcomes (1)

  • 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.

    duration of 1 eye exam, approximately 1 hour

Study Arms (3)

Glaucoma

ACTIVE COMPARATOR

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 TestDiagnostic Test: Pelli-Robson Contrast Sensitivity Chart

Controls

ACTIVE COMPARATOR

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 TestDiagnostic Test: Pelli-Robson Contrast Sensitivity Chart

Age-Related Macular Degeneration (ARMD)

ACTIVE COMPARATOR

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 TestDiagnostic Test: Pelli-Robson Contrast Sensitivity Chart

Interventions

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.

Also known as: SPARCS
Age-Related Macular Degeneration (ARMD)ControlsGlaucoma

wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.

Age-Related Macular Degeneration (ARMD)ControlsGlaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age and older
  • able to provide fully informed consent
  • 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+.
  • 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.
  • 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.
  • 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.
  • 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.

You may not qualify if:

  • any other diseases affecting visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
George L. Spaeth, MD
Organization
Wills Eye Hospital

Study Officials

  • George L Spaeth, MD

    Glaucoma Service, Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

January 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 11, 2018

Results First Posted

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Multiple manuscripts have been published.

Locations