Rod and Cone Mediated Function in Retinal Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 1/25/2019 |
| Start Date: | November 28, 2015 |
| End Date: | December 31, 2022 |
| Contact: | Daniel W Claus, R.N. |
| Email: | daniel.claus@nih.gov |
| Phone: | (301) 496-9058 |
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
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 120 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 the recently released commercial Medmont
Dark Adapted Chromatic (DAC) perimeter and/or a commercial Cambridge Research Systems
computer monitor (Display++) specialized for displaying stimuli at low light intensities. For
Aim 1 the normal ranges will be established for dark-adapted retinal sensitivities to blue
and red stimuli of the DAC perimeter, and for radial frequency (RF) hyperacuity on the
Display++ monitor. For Aim 2, the normal range will be established for describing the
kinetics of dark adaptation following bleaching of retinal rhodopsin for the DAC perimeter.
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, dark-adapted retinal sensitivity to the DAC blue and red stimuli, and/or RF
hyperacuity on the Display++ monitor.
Outcome Measures: The primary outcome for this study is to establish normal ranges for A) the
kinetics of dark adaptation (time), B) dark adapted retinal sensitivity (dB) for the Medmont
DAC blue and red stimuli, and C) RF hyperacuity on the Display++ monitor. The secondary
outcomes will be to examine changes in the kinetics of dark adaptation, dark adapted retinal
sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.
photoreceptor function across the retina in healthy volunteers and participants with retinal
disease.
Study Population: Up to 120 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 the recently released commercial Medmont
Dark Adapted Chromatic (DAC) perimeter and/or a commercial Cambridge Research Systems
computer monitor (Display++) specialized for displaying stimuli at low light intensities. For
Aim 1 the normal ranges will be established for dark-adapted retinal sensitivities to blue
and red stimuli of the DAC perimeter, and for radial frequency (RF) hyperacuity on the
Display++ monitor. For Aim 2, the normal range will be established for describing the
kinetics of dark adaptation following bleaching of retinal rhodopsin for the DAC perimeter.
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, dark-adapted retinal sensitivity to the DAC blue and red stimuli, and/or RF
hyperacuity on the Display++ monitor.
Outcome Measures: The primary outcome for this study is to establish normal ranges for A) the
kinetics of dark adaptation (time), B) dark adapted retinal sensitivity (dB) for the Medmont
DAC blue and red stimuli, and C) RF hyperacuity on the Display++ monitor. The secondary
outcomes will be to examine changes in the kinetics of dark adaptation, dark adapted retinal
sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.
- INCLUSION CRITERIA:
- Participant must be 5 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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