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

April 2, 2019 updated by: Usha Chakravarthy, Queen's University, Belfast
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • NI clinical Research Facility,51 Lisburn Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The outcome measures will be assessed at the end of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University, Belfast

Investigators

  • Principal Investigator: Prof Usha Chakravarthy, Phd FRCopth, Queens University Belfast

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/NI/1025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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