Diabetic Macular Oedema: the Retinal Thickness as a Function of Changes in Plasma Osmolality Evaluated by OCT.
Sponsor study identifier
interventional
15
1 country
1
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2006
Actual (reported)Study Completion
April 2007
Actual (reported)Diabetic macular oedema is characterized by fluid accumulation in the retinal tissue from leaking retinal vessels, the capillaries. This state can lead to severe visual loss and blindness. According to basic physiologic rules several factors influence the fluid transport between the capillaries and the surrounding tissue. One of these factors is the balance between the large molecules within the vessel lumen and the retinal tissue. Some drugs change this balance, the osmotic balance, by moving the fluid from the tissue to the vessel lumen. In relation to diabetic macular oedema, treatment with such a drug potentially would reduce the retinal thickness because it extracts fluid from the retinal tissue. Glycerol has this potential. If reduction of the thickness with glycerol is confirmed, then it proves the significance of the osmotic balance in the basic nature of diabetic macular oedema. In this study we therefore examine the time dependent change in retinal thickness after glycerol intake by an instrument called optical coherence tomography (OCT). The participants drink glycerol and the thickness of the retina is then monitored closely by OCT during the following three hours. Since diabetic changes in the retina are focal pr. definition, the secondary purpose of the study is to find any regional differences in the response. The examinations are repeated at a second visit where the patient drink another dose of glycerol, because we also want to analyse for a dose dependent response. Which dose is given at each visit is randomised on beforehand. In addition to measuring the retinal thickness a variety of examinations are performed both before and during the study, e.g. blood samples and systemic blood pressure measurements.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 2006
Actual (reported)June 2, 2006
Actual (reported)June 6, 2006
Actual (reported)April 2007
Actual (reported)Retinal thickness by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol.
Regional differences in response by fast retinal thickness mapping by optical coherence tomography at times 0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 minutes after the last swallow of glycerol
dose dependent differences in the same time spectrum.
Department of Ophthalmology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75
Herlev, DK-2730, Denmark
Thornit DN, Vinten CM, Sander B, Lund-Andersen H, la Cour M. Blood-retinal barrier glycerol permeability in diabetic macular edema and healthy eyes: estimations from macular volume changes after peroral glycerol. Invest Ophthalmol Vis Sci. 2010 Jun;51(6):2827-34. doi: 10.1167/iovs.09-4172. Epub 2009 Dec 30.
Dorte Nellemann Thornit, MD
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
15 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2006
First Posted
June 6, 2006
Study Start
December 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2006
Actual (reported)Study Completion
April 2007
Actual (reported)Last Updated
September 19, 2012
Record last verified: 2012-09
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