Color Vision as a Measure for Inherited Retinal Diseases

NCT01878032 | Completed

• 2 other identifiers: 13015413-EI-0154
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer; Retinal Disease; Inherited Retinal Degeneration

Keywords

Retinal Disease; Inherited Retinal Degeneration

Outcome Measures

Primary Outcomes (1)

• For both the CCT and LvCCT, a quantitative measure of color vision will be obtained from the calculation of achromatic area.

  Ongoing

Secondary Outcomes (4)

• Determination of variabilities of the two tests

  Ongoing

• Establishment of the normal range of color discrimination thresholds

  Ongoing

• Evaluation of effects of disease on color discrimination thresholds

  Ongoing

• Evaluation of sensitivity of the CCT and LVCCT

  Ongoing

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 5 years of age or older.
• Participant (or legal guardian) must understand and sign the protocol s informed consent document.
• Participant must be able to cooperate with the testing required for this study.
• Participant s eyes must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography.
• For IRD Participants only:
• 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.
• Participant must have a measurable visual acuity.
• For Healthy Volunteers only:
• Participant must have visual acuity of 20/20 or better.

You may not qualify if:

• Participant is taking medications known to alter color vision, such as hydroxychloroquine (Plaquenil ), sildenafil (Viagra ), ethambutol, chloroquine amiodarone, and pamidronate disodium.
• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Jacobson SG, Cideciyan AV, Ratnakaram R, Heon E, Schwartz SB, Roman AJ, Peden MC, Aleman TS, Boye SL, Sumaroka A, Conlon TJ, Calcedo R, Pang JJ, Erger KE, Olivares MB, Mullins CL, Swider M, Kaushal S, Feuer WJ, Iannaccone A, Fishman GA, Stone EM, Byrne BJ, Hauswirth WW. Gene therapy for leber congenital amaurosis caused by RPE65 mutations: safety and efficacy in 15 children and adults followed up to 3 years. Arch Ophthalmol. 2012 Jan;130(1):9-24. doi: 10.1001/archophthalmol.2011.298. Epub 2011 Sep 12.

  PMID: 21911650 BACKGROUND

• Schwartz SD, Hubschman JP, Heilwell G, Franco-Cardenas V, Pan CK, Ostrick RM, Mickunas E, Gay R, Klimanskaya I, Lanza R. Embryonic stem cell trials for macular degeneration: a preliminary report. Lancet. 2012 Feb 25;379(9817):713-20. doi: 10.1016/S0140-6736(12)60028-2. Epub 2012 Jan 24.

  PMID: 22281388 BACKGROUND

• Birch DG. A randomized placebo-controlled clinical trial of docosahexaenoic acid (DHA) supplementation for X-linked retinitis pigmentosa. Retina. 2005 Dec;25(8 Suppl):S52-S54. doi: 10.1097/00006982-200512001-00023. No abstract available.

  PMID: 16374336 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Brett G Jeffrey, Ph.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: June 3, 2013
• Primary Completion: April 14, 2017
• Study Completion: April 14, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-04-14

Locations

US (1)