Status:
COMPLETED
Quantification of Rising the Osmotic Pressure in Diabetic Intraretinal Fluid Accumulation (Diabetic Macular Oedema)
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
In general, when oedema is present, increasing the osmotic pressure in the retinal capillaries by an osmotic drug induces transcapillary fluid transport from the retinal tissue to the vascular lumen, ...
Eligibility Criteria
Inclusion
- Diabetic significant macular oedema (by biomicroscopy or OCT)
- Visual acuity of minimum 60 letters by the ETDRS chart (4 m distance)
- ETDRS grade between 35 and 53, both stages included
- baseline blood pressure of max. 160/90 mmHg
- informed consent
Exclusion
- another macular disease than diabetic macular oedema to explain the symptoms, incl. prior laser photocoagulation
- pregnancy
- moderate to severe heart or lung disease (crural oedemas, dyspnoea during low activity, or basal crackles by lung stethoscopy
- renal insufficiency with albumin excretion larger than 300 g/day
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00333671
Start Date
December 1 2004
End Date
April 1 2007
Last Update
September 19 2012
Active Locations (1)
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1
Department of Ophthalmology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75
Herlev, Denmark, DK-2730