An observational study in Retinal Degeneration, Retinitis Pigmentosa and Stargardt's Disease, sponsored by National Eye Institute (NEI). Recruiting at 1 site in United States. Open to participants aged 5 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Eye Institute (NEI) · Observational
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
...
Objective: The objective of this protocol is to investigate local changes in rod and cone photoreceptor function across the retina in healthy volunteers and participants with retinal disease.
Study Population: Up to 250 healthy volunteers and 250 participants, age five or older, with retinal disease.
Design: This single-center, observational, case-control study will be comprised of three related Aims that assess rod and cone function with commercial perimeters and/or a commercial Cambridge Research Systems computer monitor (Display++) specialized for displaying stimuli at low light intensities. For Aim 1 the normal retinal sensitivity ranges will be established for both fundus-guided and non-guided perimeters. For Aim 2, the normal range for describing the kinetics of dark adaptation following bleaching of retinal rhodopsin will be established for the fundus-guided and non-guided perimeters. For Aim 3, local changes in rod and cone photoreceptor function across the retina in participants with retinal disease will be examined from measurement of the kinetics of dark adaptation, scotopic and photopic retinal sensitivity, and/or Radial Frequency (RF) hyperacuity on the Display++ monitor. Testing may also include patient reported outcome (PRO) questionnaires to assess vision problems under low luminance conditions. For Aim 4, a subset of retinal disease participants (approximately 40) will complete two electroretinogram (ERG) sessions to develop a scaling factor to allow comparison with historical clinical data. The scaling factor will be used in the NEI ophthalmology clinic to account for changes in ERG parameters in patients tested using the current system compared to older clinical results.
Outcome Measures: The primary outcome for this study is to establish normal ranges for A) the kinetics of dark adaptation (time), B) retinal sensitivity (dB) for the fundus-guided and non-guided perimeters, and C) RF hyperacuity on the Display++ monitor. The secondary outcomes will be to examine changes in the kinetics of dark adaptation, scotopic and photopic retinal sensitivity, and/or RF hyperacuity in participants with retinal disease and potentially correlate these clinical measures with patients self-reported evaluation of their vision under low luminance conditions. An exploratory outcome will be to define a scaling factor for ERGs recorded with the RM electrode on the MonCV electrophysiology systems (MonCvONE and MonPackONE, Metrovision France) with the ERG data previously recorded with the Burian-Allen (BA) electrode on the commercial UTAS(TM) electrophysiology system.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 500 is above the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Compared within Retinitis Pigmentosa, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Retinal Degeneration. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Up to 250 participants with retinal disease will be enrolled and up to 120 healthy volunteers will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Participants with retinal disease only:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with retinal disease
Healthy volunteers
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++.
Time frame: ongoing, up to 10 visits in 5 years
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.
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.
Time frame: ongoing, up to four visits in 5 years
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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