A Systematic Study of Retinal Structure and Function in Diabetic Macular Oedema

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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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Macular Edema Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NI clinical Research Facility,51 Lisburn Road

Belfast, BT9 7AB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1 (Healthy controls without DM):

Persons older than 18 years without DM
Fundus free of any signs of retinal disease
Best Corrected Visual Acuity of 20/40 (73 ETDRS letters) in both eyes

Group 2 (Persons with DM with no retinopathy):

Persons with Type 1 or type 2 diabetes older than 18 years
Normal fundus, Absence of features of DR or DMO in both eyes
Best Corrected Visual Acuity 20/40 (73 ETDRS letters) in at least one eye

Group 3:

Persons with Type 1 or type 2 diabetes 18 years and older
Fundus signs of mild, moderate or severe DR and or DMO
Best Corrected Visual Acuity 20/200 (33 ETDRS letters) or better

Exclusion criteria

Recent ocular surgical procedures performed within the previous 3 months
Presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis
Serious life threatening conditions that would preclude attendance in the longitudinal part of the study
Neurological conditions that can impair vision

Treatment and study plan

Primary outcomes

Presence of DMO evaluated from the optical coherence tomography (OCT) images

Time frame: The outcome measures will be assessed at the end of 3 months

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Aug 23, 2016
Registry last updated: Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed