Rod and Cone Mediated Function in Retinal Disease

NCT02617966 | Recruiting

• 2 other identifiers: 16002416-EI-0024
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Degeneration; Retinitis Pigmentosa; Stargardt's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark-adapted retinal sensitivity for the fundus guided and non-guided perimeters and for RF hyperacuity on the Display++.

  The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark-adapted retinal sensitivity for the fundus guided and non-guided perimeters and for RF hyperacuity on the Display++.

  ongoing, up to 10 visits in 5 years

Secondary Outcomes (1)

• Secondary outcomes will be to examine changes in the kinetics of dark adaptation and dark-adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.

  ongoing, up to four visits in 5 years

Study Arms (2)

Affected

Participants with retinal disease

Unaffected

Healthy volunteers

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 250 participants with retinal disease will be enrolled and up to 120 healthy volunteers will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• 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. doi: 10.1016/s1568-1637(02)00007-7.

  PMID: 12067593 BACKGROUND

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

  PMID: 422332 BACKGROUND

• 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.

  PMID: 21810977 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Retinal Degeneration; Retinitis Pigmentosa; Stargardt Disease

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Macular Degeneration

Study Officials

• Brett G Jeffrey, Ph.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel W Claus, R.N.

CONTACT

(301) 451-1621; daniel.claus@nih.gov

Brett G Jeffrey, Ph.D.

CONTACT

(301) 402-2391; jeffreybg@mail.nih.gov

Study Design

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

Study Record Dates

• First Submitted: November 28, 2015
• First Posted: December 1, 2015
• Study Start: March 24, 2016
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04-15

Locations

US (1)