Spaeth/Richman Contrast Sensitivity Test (SPARCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Wills Eye
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01300949
First received: February 22, 2011
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast sensitivity. The test is performed on any standard computer with internet access. Patients will be tested with SPARCS and with the standard Pelli-Robson contrast test.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Contrast Sensitivity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    If this instrument is a user-friendly, highly specific and sensitive method of determining contrast sensitivity, without influence of acuity, a major advance will be made. It is conceivable that the test could be used for detection of visual disease globally because of ease of operation and availability. Increasing numbers of studies are showing that contrast sensitivity is highly related to patients' ability to perform activities of daily living. It is anticipated that using this technique may become the standard way of assessing visual ability.


Estimated Enrollment: 315
Study Start Date: January 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Objective: To test a new method of determining contrast sensitivity that does not require visual acuity and tests various areas of the visual field.

Hypothesis: A method of determining contrast sensitivity that does not require letter recognition (as in the Pelli-Robson test) eliminates the confounders of literacy and pattern recognition, and will 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Glaucoma Service, Wills Eye Institute Cataract and Primary Care Service, Wills Eye Institute Retina Service, Wills Eye Institute

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300949

Contacts
Contact: Sheryl S Wizov, COA 215-928-3221 swizov@willseye.org
Contact: Jeanne Molineaux, COA 215-825-4713 jmolineaux@willseye.org

Locations
United States, Pennsylvania
Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sheryl S Wizov, COA    215-928-3221    swizov@willseye.org   
Contact: Jeanne Molineaux, COA    215-825-3417    jmolineaux@willseye.org   
Principal Investigator: George L Spaeth, MD         
Sub-Investigator: L Jay Katz, MD         
Sub-Investigator: Marlene R Moster, MD         
Sub-Investigator: Jonathan S Myers, MD         
Sub-Investigator: Michael J Pro, MD         
Sub-Investigator: Courtland Schmidt, MD         
Sub-Investigator: Scott J Fudemberg, MD         
Sponsors and Collaborators
Wills Eye
Pfizer
Investigators
Principal Investigator: George L Spaeth, MD Glaucoma Service, Wills Eye Institute
  More Information

No publications provided

Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01300949     History of Changes
Other Study ID Numbers: 10-998
Study First Received: February 22, 2011
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wills Eye:
Contrast Sensitivity
Pelli-Robson Test

ClinicalTrials.gov processed this record on September 16, 2014