Color Vision as a Measure for Inherited Retinal Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier:
NCT01878032
First received: June 12, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

Background:

- The purpose of this study is to find out whether color vision measured with the Cambridge Color Test is a good way to examine the severity of inherited retinal diseases (IRDs). IRDs are a major cause of vision loss worldwide, but very little is known about how the diseases affect color vision over time. This study will tell us if color vision may be used to track changes in inherited retinal diseases over time.

Objectives:

- To improve understanding of color vision as a way to measure changes in inherited retinal diseases.

Eligibility:

  • People 5 years of age or older who have an IRD.
  • Healthy volunteers at least 5 years of age.

Design:

  • Participants will make at least one visit to the National Eye Institute clinic. If they sign up for more tests, they may have up to three visits to the NEI clinic.
  • Participants will be asked questions about their medical and eye history.
  • Participants will be given an eye exam, including eye drops to dilate their pupils. They will take the Cambridge Color Test, which includes looking at a monitor and pressing a button, and arranging colored circles. Several other tests may be offered, but participants can decline to take them.
  • Treatment will not be provided as part of this study.

Condition
Healthy Volunteer
Retinal Disease
Inherited Retinal Degeneration

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Color Vision as an Outcome Measure for Clinical Trials of Inherited Retinal Degenerations

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluate the sensitivity of the Cambridge Color Test to the severity of inherited retinal disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 233
Study Start Date: June 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Objective: The aims of this study are to 1) examine the sensitivity of the Cambridge Color Test (CCT) and the low vision CCT (LvCCT) to the severity of retinal disease in inherited retinal degeneration (IRD) by comparing color vision status with changes in photoreceptor structure and function, 2) examine the effects of eccentric fixation and reduction in visual acuity on color discrimination thresholds obtained with the CCT and LvCCT, and 3) establish normal ranges for the CCT and the LvCCT and determine the intra-session and inter-session variabilities for these tests.

Study Population: Up to 89 healthy volunteers and 144 IRD participants age 5 or older will be enrolled in this study. The IRD participants participating in Aim 1 may participate in Aim 3 as well, and healthy volunteers may elect to participate in one or more of the aims. As such, there will be overlap in the population accrued for each aim.

Design: This study will be comprised of three related projects. For Aim 1, color discrimination thresholds (CCT and LvCCT) and assessments of retinal structure (imaging) and function (perimetry/microperimetry and electroretinogram) will be measured in 30 healthy volunteers and 120 IRD participants with varying retinal phenotypes and visual acuities. IRD participants will be divided into four major categories: 1) cone & cone-rod dystrophies, 2) rod-cone dystrophies, 3) inherited maculopathies, and 4) inherited retinal dysfunction syndromes. The fourth category will be used for IRDs that do not match the description for categories 1-3 (i.e., x-linked retinoschisis, congenital stationary night blindness). Degree of severity of retinal dysfunction in IRD participants will be determined relative to the normal ranges obtained from the healthy volunteers. For Aim 2 color discrimination thresholds (CCT and LvCCT) will be measured in one eye from 12 healthy volunteers in order to examine the effects of eccentric fixation and reduced visual acuity on color thresholds independent of retinal pathology. Between one and three study visits will be required for this aim. Aim 3 will be comprised of two parts. For Aim 3a, color thresholds will be collected from both eyes (for intraocular variability) of 35 healthy volunteers age 5 or older. For Aim 3B, color discrimination thresholds (CCT and LvCCT) will measured twice in one session and then again at a second visit occurring within two months of the initial visit to determine intra-session and inter-session variability. Variability will be determined from 12 healthy volunteers and 24 IRD participants.

Outcome Measures: For both the CCT and LvCCT, an overall quantitative measure of color vision will be obtained from the calculation of achromatic area. The sensitivity of CCT and LvCCT will be examined by comparing achromatic area for IRD participants with varying levels of phenotype severity defined by measures of retinal structure and function. Secondary outcomes for this study include: 1) evaluation of sensitivity of the CCT and LvCCT to disease severity, 2) evaluation of the effects of decreased visual acuity and eccentricity on color discrimination nthresholds (CCT and LvCCT), 3) establishment of the normal range of color discrimination thresholds (CCT and LvCCT) as a function of age, and 4) determination of intra- and intersession variabilities of the two tests.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Participants must be 5 years of age or older.
    2. Participant (or legal guardian) must understand and sign the protocol s informed consent document.
    3. Participant must be able to cooperate with the testing required for this study.
    4. Participant s eyes must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography.
    5. For IRD Participants only:

      1. Participant must have IRD, defined as evidence of retinal rod- and cone-mediated

        dysfunction and degeneration established by standard clinical methods including field tests, ERG, and imaging.

      2. Participant must have a measurable visual acuity.
    6. For Healthy Volunteers only:

      1. Participant must have visual acuity of 20/20 or better.

EXCLUSION CRITERIA:

  1. Participant is taking medications known to alter color vision, such as hydroxychloroquine (Plaquenil ), sildenafil (Viagra ), ethambutol, chloroquine amiodarone, and pamidronate disodium.
  2. Participant has another ocular disease that may confound the study results, such as diabetic retinopathy, vascular occlusions, retinopathy related to drug toxicity, optic neuropathy, or central serous chorioretinopathy.
  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: NCT01878032

Contacts
Contact: Allison T Bamji, R.N. (301) 451-3437 bamjia@nei.nih.gov
Contact: Brett G Jeffrey, Ph.D. (301) 402-2391 jeffreybg@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Brett G Jeffrey, Ph.D. National Eye Institute (NEI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT01878032     History of Changes
Other Study ID Numbers: 130154, 13-EI-0154
Study First Received: June 12, 2013
Last Updated: April 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Retinal Disease
Inherited Retinal Degeneration

Additional relevant MeSH terms:
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014