Retinal DegenerationNCT02617966
Rod and Cone Mediated Function in Retinal Disease
An observational study of Retinal Degeneration and Retinitis Pigmentosa, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Degeneration, Retinitis Pigmentosa, Stargardt's Disease
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2016to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Up to 250 participants with retinal disease will be enrolled and up to 120 healthy volunteers will be enrolled.
Who may be able to join
- 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.
Who cannot join
- -Participant with changes in pre-retinal media sufficient to obscure a view of the retina.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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
Read the detailed description
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.
- Keywords
- Retina, Retinal Degeneration, Retinitis Pigmentosa, Stargardt's Disease, Dark Adaptation
- Medical subject headings
- Retinal Degeneration, Retinitis Pigmentosa, Stargardt Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected | Participants with retinal disease | |
| Unaffected | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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++.
Measured: 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.
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.
Measured: ongoing, up to four visits in 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start24 Mar 2016
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brett G Jeffrey, Ph.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617966
- Sponsor's protocol ID
- 160024
- Other IDs
- 16-EI-0024
- Status last verified
- 18 Aug 2026
- First submitted
- 28 Nov 2015
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12067593Massof RW, Finkelstein D. Rod sensitivity relative to cone sensitivity in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1979 Mar;18(3):263-72.
PubMed 422332Birch 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.
PubMed 21810977
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rod and Cone Mediated Function in Retinal Disease
- ClinicalTrials.gov ID
- NCT02617966
- Acronym / sponsor ID
- 160024
- Keywords
- Retina, Retinal Degeneration, Retinitis Pigmentosa, Stargardt's Disease, Dark Adaptation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected | – | –Participants with retinal disease |
| Unaffected | – | –Healthy volunteers |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 250 participants with retinal disease will be enrolled and up to 120 healthy volunteers will be enrolled.
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- -Participant with changes in pre-retinal media sufficient to obscure a view of the retina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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++.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 12067593Jackson 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.
- Background: PubMed 422332Massof RW, Finkelstein D. Rod sensitivity relative to cone sensitivity in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1979 Mar;18(3):263-72.
- Background: PubMed 21810977Birch 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Retinal Degeneration
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Active, not recruitingObservational study
Natural History of Eye Diseases Related to ABCA4 Mutations
Retinal Degeneration, ABCA4-Related Retinopathies
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
Enrolling by invitation
Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
Geographic Atrophy
Not yet recruitingPhase 1/2
Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA-Associated Inherited Retinal Degeneration (LCA-IRD)
Leber Congenital Amaurosis, Leber Congenital Amaurosis (LCA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brett G Jeffrey, Ph.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Degeneration and Retinitis Pigmentosa, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel W Claus, R.N. ((301) 451-1621, daniel.claus@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617966, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.