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Diabetic retinopathy(DR) is a sight threatening condition that occurs in persons with diabetes. DR arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. An eye with DR will have abnormal appearing retinal blood vessels which become engorged and dilated, leaky and fragile or undergo closure. The net result is a picture of haemorrhage and or ischaemia (lack of blood supply). A particular feature of DR is the accumulation of fluid in the macula which is the central part of the retina and responsible for detailed eye sight. This peculiar form of DR is called Diabetic Macular Oedema (DMO). DMO can occur in isolation without other features of DR. DMO is commoner in type 2 diabetes where insulin resistance and abnormalities of blood fats are found. The investigators wish to study DR and DMO using high resolution retinal imaging and functional tests in normal participants, those participants with diabetes without any overt signs of disease and those with DR and DMO in order to understand how the condition develops and whether there are any unique risk factors that can be identified
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Persons with type 1 or type 2 DM with features of DR and or DMO ranging from extremely mild to severe. | ||
| Control definition | Persons with a history of type 1 or type 2 DM without any clinical features of DR or DMO in either eye or persons without a history of DM and without retinal disease in either eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of DMO evaluated from the optical coherence tomography (OCT) images | The outcome measures will be assessed at the end of 3 months |
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Inclusion Criteria:
Group 1 (Healthy controls without DM):
Group 2 (Persons with DM with no retinopathy):
Group 3:
Exclusion Criteria:
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Potential participants with DR of different severity levels ranging from minimal DR to severe DR with or without DMO who attend the diabetic clinics will be invited to participate. Opportunistic sampling will be used to ensure that the different severity levels of DR and or DMO will be adequately represented.The Northern Ireland Cohort Longitudinal Study On ageing (NICOLA), a non-interventional epidemiological study of healthy ageing in older adults aged 50 years and above has commenced and is currently recruiting some 8500 participants. Participants in NICOLA who are known to have DM or have been recently diagnosed with DM will be approached and asked if willing to return for detailed functional testing of the eye. This will supplement the group with DM but with no changes of DR.
Control participants with DM but without DR will be recruited from the metabolic clinics of the Belfast Trust.
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| Name | Affiliation | Role |
|---|---|---|
| Prof Usha Chakravarthy, Phd FRCopth | Queens University Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NI clinical Research Facility,51 Lisburn Road | Belfast | BT9 7AB | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 3, 2022 | |
| Reset | May 19, 2022 | |
| Release | Sep 7, 2022 | |
| Reset | Jul 26, 2023 | |
| Release | Apr 20, 2024 | |
| Reset | Sep 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 3, 2022 | May 19, 2022 | |||
| Sep 7, 2022 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Jul 26, 2023 |
| Apr 20, 2024 | Sep 16, 2024 |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |