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

Sponsor
Queen's University, Belfast (Other)
Overall Status
Completed
CT.gov ID
NCT02876393
Collaborator
(none)
172
Enrollment
1
Location
26
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    172 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Systematic Study of Retinal Structure and Function in Diabetic Macular Oedema
    Actual Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Presence of DMO evaluated from the optical coherence tomography (OCT) images [The outcome measures will be assessed at the end of 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NI clinical Research Facility,51 Lisburn Road Belfast United Kingdom BT9 7AB

    Sponsors and Collaborators

    • Queen's University, Belfast

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Usha Chakravarthy, Professor, Queen's University, Belfast
    ClinicalTrials.gov Identifier:
    NCT02876393
    Other Study ID Numbers:
    • 14/NI/1025
    First Posted:
    Aug 23, 2016
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:
    Macular Edema
    Diabetic Retinopathy
    Edema

    Study Results

    No Results Posted as of Apr 4, 2019