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Protocol Details

Rod and Cone Mediated Function in Retinal Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-EI-0024

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Retina;
Retinal Degeneration;
Retinitis Pigmentosa;
Stargardt's Disease;
Dark Adaptation

Recruitment Keyword(s)

None

Condition(s)

Retinal Degeneration;
Retinitis Pigmentosa;
Stargardt's Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

Background:

Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal disease. They want to know if how well a person sees in the dark can test the severity of retinal disease.

Objectives:

To find out if how well a person sees in the dark can test the severity of retinal disease. To find out if this can help detect retinal disease and track its changes.

Eligibility:

People ages 5 and older with:

Retinal disease OR

20/20 vision or better with or without correction in at least one eye

Design:

Participants will be screened with medical and eye history and eye exam. Those with retinal disease will also have:

Eye imaging: Drops dilate the eye and pictures are taken of it.

Visual field testing: Participants look into a bowl and press a button when they see light.

Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the

dark with their eyes patched for 30 minutes. Then they get numbing drops and contact

lenses. Participants watch lights while retina signals are recorded.

Visit 1 will be 3-8 hours. Participants will have up to 6 more visits over 6-12 months. Visits include:

Eye exam and imaging

Time course of dark adaptation: Participants view a background light for 5 minutes then

push a button when they see colored light.

Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button when

they see colored light.

For participants with retinal disease, ERG and visual field testing

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Eligibility

INCLUSION CRITERIA:

-Participant must be five 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.

For Participants with retinal disease only:

-Participant must have retinal disease, defined as evidence of loss of retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.

-Participant must have a measurable visual acuity.

For Healthy Volunteers only:

-Participant must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens) in at least one eye.

EXCLUSION CRITERIA:

-Participant with changes in pre-retinal media sufficient to obscure a view of the retina.


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Citations:

Jackson GR, Owsley C, Curcio CA. Photoreceptor degeneration and dysfunction in aging and age-related maculopathy. Ageing Res Rev. 2002 Jun;1(3):381-96. Review.

Massof RW, Finkelstein D. Rod sensitivity relative to cone sensitivity in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1979 Mar;18(3):263-72.

Birch DG, Wen Y, Locke K, Hood DC. Rod sensitivity, cone sensitivity, and photoreceptor layer thickness in retinal degenerative diseases. Invest Ophthalmol Vis Sci. 2011 Sep 9;52(10):7141-7. doi: 10.1167/iovs.11-7509.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Brett G. Jeffrey, Ph.D.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10C442
10 Center Drive
Bethesda, Maryland 20892
(301) 402-2391
jeffreybg@mail.nih.gov

Daniel W. Claus, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1621
daniel.claus@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02617966

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