ISRCTN30128134已完成未知
Prospective clinical study of Indocyanine-Green dye immune cell imaging in the human eye
niversity of Bristol0 个研究点目标入组 12 人开始时间: 2017年4月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
2020 results in https://doi.org/10.1371/journal.pone.0226311 (added 24/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 18 years of age or over with legal capacity to consent
- •2. Able to travel and attend the full programme within the funded travel cost budget
- •In addition, ocular inclusion criteria must be met:
- •Cohort 1 - recruitment of 8 patients:
- •1. With likely or suspected Choroidal Neovascular Membrane or Central Serous Retinopathy that clinically requires ICG angiography (with or without combined fluorescein angiography)
- •2. Macular sub-retinal fluid is present and at least 500µm in diameter on a spectral-domain OCT scan
- •3. Any obscuring haemorrhage should not exceed more than 50% of the area of the sub-retinal fluid
- •4. Not due for intravitreal injection or photodynamic therapy within the first 48 hours of the study period
- •Cohort 2 - recruitment of 4 patients:
- •1. With likely or suspected posterior uveitis or panuveitis that clinically requires ICG angiography (with or without combined fluorescein angiography)
- •2. Clinically suspected vasculitis
- •3. No intravitreal therapy has been administered within 3 months prior or will be administered during the study period
- •4. Mild vitritis only (with a SUN Haze score =2)
- •Cohort 3 - recruitment of 3 healthy control volunteers:
- •1. No known ocular pathology
- •2. No known refractive error larger than +3.00 dioptres or -3.00 dioptres spherical equivalent in either eye
- •3. Self reported normal community optometry examination within one year prior to recruitment
- •4. Normal colour fundal photography at start of study
- •Cohort 4 - recruitment of 3 patients:
- •1. Known ocular pathology where ICG angiography is not normally indicated
- •2. Diagnoses can include Diabetic Macular Oedema, Proliferative Diabetic Retinopathy, cystoid macular oedema, geographic atrophy or other forms of uveitis not included in Cohort 2
- •3. Patients meeting the criteria for Cohorts 1 and 2 may also be included, but given ICG alone without combined Fluorescein as in the usual standard of care
排除标准
- •1. Known fluorescein, ICG, iodine or shellfish allergy
- •2. Any known contraindication to topical Tropicamide and Phenylephrine dilating drops
- •3. Known renal (eGFR =80 mL/min/1.73m2) or hepatic dysfunction or active disease that in the opinion of the investigator will contraindicate the administration of ICG
- •4. Unable to be easily imaged on Spectralis, Optos or Topcon retinal imaging machines (e.g. marked kyphosis or physical impairment)
- •5. Significant media opacity leading to poor image quality. (e.g. vitreous haemorrhage or cataract)
- •6. Unable to donate a peripheral blood sample or known HIV, Hep B or C
- •7. Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation. A pregnancy test will be performed on all female participants of childbearing age prior to ICG injection
- •8. Each participant may only enter the study once and cannot currently be enrolled in another research trial
研究者
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