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Trial registered on ANZCTR


Registration number
ACTRN12609000362291
Ethics application status
Approved
Date submitted
18/05/2009
Date registered
26/05/2009
Date last updated
5/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial to determine if the review of non-mydriatic retinal images can contribute to a reduction in glycosylated hemoglobin in patients with poor control of their blood sugar diabetic retinopathy
Scientific title
A Prospective randomized control trial to determine if the review of nonmydriatic retinal images in poorly controlled diabetic patients with diabetic retinopathy at the time of endocrinology visit can lower glycosylated hemoglobin (HbA1C).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy 4814 0
Condition category
Condition code
Eye 237156 237156 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 237203 237203 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The “intervention” group will have a nonmydriatic imaging of each retina (45 degrees one field centered between fovea and optic nerve head) following their endocrinologist exam, followed by a brief discussion by a retina specialist about the findings. The patients will be shown their images during this discussion and the following topics will be explicitly discussed with each patient: First, a series of images comprising a spectrum starting from a normal appearing fundus to images of mild and moderate nonproliferative diabetic retinopathy (DR), active proliferative DR and tractional retinal detachment. Second, ongoing blood glucose control will be stressed in order to delay or avoid worsening of their retinopathy and finally a brief summary of the results of the Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) regarding HbA1C control and DR.
Intervention code [1] 4588 0
Early detection / Screening
Comparator / control treatment
The “control” group would differ in that they will not have the imaging following their endocrinologist exam and will not have a discussion with the retinal specialist. These patients will be evaluated according to their previously determined, regularly scheduled ophthalmology follow up. Diabetic eye care will be otherwise the same in both groups.
Control group
Active

Outcomes
Primary outcome [1] 237974 0
blood analysis of HbA1C at study entry and at 3 months follow up level
Timepoint [1] 237974 0
Baseline and at 3 months following treatment
Secondary outcome [1] 242079 0
none
Timepoint [1] 242079 0
n/a

Eligibility
Key inclusion criteria
patients with type 1 or type 2 diabetes mellitus, as defined by the expert committee on the diagnosis and classification of Diabetes Mellitus, patients with documented poor glycemic control as reflected in a HbA1C> or = 8.0% within 1 month of baseline, patients with recently recognized clinical changes of DR in their medical record (Early Treatment Diabetic Retinopathy Study scores of 20 and above), and ability to obtain nonmydriatic retinal images
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
gestational diabetes mellitus, media clarity inadequate for nonmydriatic retinal imaging, poor visual acuity (Early Treatment Diabetic Retinopathy Study Visual Acuity < 20/100) and patients using pupillary constricting agents as a treatment modality for glaucoma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized by having every other patient enroll to the intervention arm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1783 0
Lebanon
State/province [1] 1783 0

Funding & Sponsors
Funding source category [1] 4975 0
Self funded/Unfunded
Name [1] 4975 0
Address [1] 4975 0
Country [1] 4975 0
Primary sponsor type
Hospital
Name
American University of Beirut Medical Center
Address
Bliss Street PoBox 110236
Beirut
Country
Lebanon
Secondary sponsor category [1] 4500 0
None
Name [1] 4500 0
Address [1] 4500 0
Country [1] 4500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7079 0
institutional review board-membership complies with US code of federal regulation (21CFR56 and 45 CFR46) of the Food and Drug Administration (FDA).
Ethics committee address [1] 7079 0
Ethics committee country [1] 7079 0
Lebanon
Date submitted for ethics approval [1] 7079 0
Approval date [1] 7079 0
Ethics approval number [1] 7079 0

Summary
Brief summary
To evaluate the addition of discussing retinal images and their findings during an endocrinology evaluation of poorly controlled diabetic patients with diabetic retinopathy on follow up blood glucose control measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29620 0
Address 29620 0
Country 29620 0
Phone 29620 0
Fax 29620 0
Email 29620 0
Contact person for public queries
Name 12867 0
Haytham Salti
Address 12867 0
American University of Beirut Medical (AUBMC) Center Bliss street, PoBox 11 0236
Country 12867 0
Lebanon
Phone 12867 0
+961 3776683
Fax 12867 0
Email 12867 0
hs06@aub.edu.lb
Contact person for scientific queries
Name 3795 0
Ibrahim Salti
Address 3795 0
AUBMC Bliss Street, Riad El Solh PoBox 110236
Beirut
Country 3795 0
Lebanon
Phone 3795 0
+961 3344994
Fax 3795 0
Email 3795 0
isalti@aub.edu.lb

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary