Rod and Cone Mediated Function in Retinal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 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++.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Participant with changes in pre-retinal media sufficient to obscure a view of the retina.
研究组 & 干预措施
Unaffected
Healthy volunteers
Affected
Participants with retinal disease
结局指标
主要结局
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++.
时间窗: 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++.
次要结局
- 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)