Imaging immune cells in the human eye using Indocyanine-Green dye
- Conditions
- Eye DiseasesKnown ocular diseases including neovascular age-related macular degeneration, posterior uveitis and central serous retinopathy
- Registration Number
- ISRCTN30128134
- Lead Sponsor
- niversity of Bristol
- Brief Summary
2020 results in https://doi.org/10.1371/journal.pone.0226311 (added 24/02/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visualisation of ICG cell labelling in the eyes of patients with diseases affecting the eye, based upon retinal photograph images assessed by the chief investigator from any session up to the 7 days
- Secondary Outcome Measures
Name Time Method <br> 1. The optimum time after ICG injection for cells to be seen<br> 2. Absence of ICG cell signals in control eyes without disease<br> 3. Detection and characterisation of ICG labelled cells using flow cytometry in peripheral blood samples taken following ICG injection<br>