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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

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).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000362291
Enrollment
120
Registered
2009-05-26
Start date
2009-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 m

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.

Sponsors

American University of Beirut Medical Center
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026