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

NCT ID: NCT02876393

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-01-31

Brief Summary

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

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

Persons with type 1 or type 2 DM with features of DR and or DMO ranging from extremely mild to severe.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Usha Chakravarthy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof Usha Chakravarthy, Phd FRCopth

Role: PRINCIPAL_INVESTIGATOR

Queens University Belfast

Locations

NI clinical Research Facility,51 Lisburn Road

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

14/NI/1025

Identifier Type: -

Identifier Source: org_study_id