The Effect of Dopamine on Diabetic Retinopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Contrast Sensitivity assessed by the Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
研究概览
简要总结
The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device.
Investigators also seek to assess if a medication called Sinemet™ CR can improve the electrical functions of the eye in participants with diabetes mellitus. This study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be randomized to a low or high dose Sinemet CR group.
详细描述
The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device.
Investigators also seek to assess if a medication called Sinemet™ CR can improve the electrical functions of the eye in participants with diabetes mellitus. This study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be randomized to a low or high dose Sinemet™ CT group.
Age-matched controls will not receive Sinemet Ct drug treatment.
The study involves four visits over the course of 4 weeks, each visit consisting of 2-3 hours. Visual testing will be performed at 1 day and 2 weeks following treatment. The drug treatment will be halted and testing repeated again after a 2 week wash-out period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Diabetes Group - Low Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
干预措施: Low Dose Sinemet CR (Drug)
Diabetes Group - Low Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
干预措施: RETeval Electroretinogram (ERG) Testing (Device)
Diabetes Group - Low Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
干预措施: Contrast Sensitivity Testing (Other)
Diabetes Group - Low Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive low dose Sinemet CR twice daily for two weeks.
干预措施: Visual Acuity Testing (Other)
Diabetes Group - High Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
干预措施: High Dose Sinemet CR (Drug)
Diabetes Group - High Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
干预措施: RETeval Electroretinogram (ERG) Testing (Device)
Diabetes Group - High Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
干预措施: Contrast Sensitivity Testing (Other)
Diabetes Group - High Dose Sinemet CR
Participants with diabetes mellitus type-2 and electroretinogram (ERG) delays will receive high dose Sinemet CR twice daily for two weeks.
干预措施: Visual Acuity Testing (Other)
Diabetes Group - No Electroretinogram (ERG) Delays
Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
干预措施: RETeval Electroretinogram (ERG) Testing (Device)
Diabetes Group - No Electroretinogram (ERG) Delays
Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
干预措施: Contrast Sensitivity Testing (Other)
Diabetes Group - No Electroretinogram (ERG) Delays
Participants with diabetes mellitus type-2 who do not have electroretinogram (ERG) delays. Participants in this group will have one baseline visit only.
干预措施: Visual Acuity Testing (Other)
Age-Matched Controls
Participants will serve as age-matched controls for participants with diabetes. This group will participate in the baseline, week 2, and week 4 visits only.
干预措施: RETeval Electroretinogram (ERG) Testing (Device)
Age-Matched Controls
Participants will serve as age-matched controls for participants with diabetes. This group will participate in the baseline, week 2, and week 4 visits only.
干预措施: Contrast Sensitivity Testing (Other)
Age-Matched Controls
Participants will serve as age-matched controls for participants with diabetes. This group will participate in the baseline, week 2, and week 4 visits only.
干预措施: Visual Acuity Testing (Other)
结局指标
主要结局
Change in Contrast Sensitivity assessed by the Contrast Sensitivity Function v1.0 (CSF v1.0) Tablet Application
时间窗: Baseline, Week 4
Participants will view the screen monocularly while wearing their normal correction. A drifting grating will be presented at 60 cm for 3, 6, 12 and 18 c/d. Following photopic testing (100 lux), the participant will be dark-adapted and a neutral density filter will be applied to the tablet screen to produce luminance of \~1 lux.
Change in Retinal Function assessed by Electroretinogram (ERG) Device
时间窗: Baseline, Week 4
The RETeval device consists of a hand-held wand with a pupil tracker. A skin electrode placed below the eye or DTL fiber records the response to flash stimuli. The pupil tracker provides feedback to the system so that the flash stimuli can compensate for the pupil size and produce the proper illumination to the retina. RETeval is intended to generate photopic signals and measure and display the electrical response signals generated by the retina and the visual nervous system using flash stimuli.
Change in Contrast Sensitivity assessed by the Sine Wave Grafting Test (CSV-1000E)
时间窗: Baseline, Week 4
The CSV-1000E is self-illuminated (85 cd/m2). A drifting grating will be presented at 60 cm for 3, 6, 12 and 18 c/d. The participant will view the chart from 2.5m. The intensity of the CSV-1000 will be reduced to 1 lux with neutral density filters for scotopic testing.
Change in Visual Acuity assessed by the Standard Snellen Static Chart
时间窗: Baseline, Week 4
The common Snellen chart is printed with eleven lines of block letters. The first line consists of one very large letter, which may be one of several letters, for example E, H, or N. Subsequent rows have increasing numbers of letters that decrease in size. Participants will cover one eye from 6 metres or 20 feet away, and read aloud the letters of each row, beginning at the top. The smallest row that can be read accurately indicates the visual acuity in that specific eye. The test will be repeated covering the opposite eye.
次要结局
未报告次要终点
研究者
Machelle Pardue
Adjunct Professor
Emory University