Investigating rod and cone function in retinal diseases
Rod and Cone Mediated Function in Retinal Disease
This study is testing how well the light-sensitive cells in the eyes work in people with retinal diseases and healthy volunteers to help understand vision changes in low light.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 5 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02617966 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the function of rod and cone photoreceptors in individuals with retinal diseases, such as Retinitis Pigmentosa and Stargardt's Disease, as well as in healthy volunteers. Participants aged five and older will undergo various tests, including eye imaging, visual field testing, and electroretinograms, to evaluate their vision under low light conditions. The study seeks to establish normal ranges for dark adaptation kinetics and retinal sensitivity, which could help in detecting and tracking the progression of retinal diseases.
Who should consider this trial
Good fit: Ideal candidates include individuals aged five and older with retinal diseases or those with 20/20 vision or better in at least one eye.
Not a fit: Patients with significant changes in pre-retinal media that obscure the view of the retina may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for assessing the severity and progression of retinal diseases, potentially leading to better management and treatment strategies for affected patients.
How similar studies have performed: Other studies have shown success in assessing retinal function using similar methodologies, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Brett G Jeffrey, Ph.D. — National Eye Institute (NEI)
- Study coordinator: Daniel W Claus, R.N.
- Email: daniel.claus@nih.gov
- Phone: (301) 451-1621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.