Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333671
Status:
COMPLETED
Last Update Posted:
2012-09-19
First Post:
2006-06-02
Brief Title:
Quantification of Rising the Osmotic Pressure in Diabetic Intraretinal Fluid Accumulation Diabetic Macular Oedema
Sponsor:
Glostrup University Hospital Copenhagen
Organization:
Glostrup University Hospital Copenhagen
Study Overview
Official Title:
Diabetic Macular Oedema the Retinal Thickness as a Function of Changes in Plasma Osmolality Evaluated by OCT
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 eg blood samples and systemic blood pressure measurements
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 eg blood samples and systemic blood pressure measurements
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 according to the Starling equation Theoretically in diabetic macular oedema the event would lead to reduction of the retinal thickness which could then be visualised by Optical Coherence Tomography The main purpose of this trial is therefore to evaluate and quantify the changes in retinal thickness of the oedema after increasing the intracapillary osmotic pressure with glycerol ingestion A reduction of the retinal thickness will confirm the application of the Starling osmotic forces on diabetic macular oedema Secondly we want to describe any regional differences in the retinal response and analyse for dose dependent variations
Principles of material and methods A prospective randomized clinical trial on 15 patients with diabetic significant macular oedema At baseline the patients undergo a thorough ophthalmologic examination including ETDRS visual acuity slit lamp biomicroscopy Optical Coherence Tomography Stratus-OCT 7-field fundus photography followed by fluorescein angiography In addition the systemic blood pressure is measured and blood samples are taken to rule out severe renal insufficiency and to estimate glycosylated haemoglobin
The patients are all randomised to drink either 15 or 3 mL glycerolkg body weight max 250 mL pr day on the first of two visit dates The last dose is given at the second visit In the following three hours the retinal thickness is then monitored closely by Stratus-OCT after the glycerol ingestion
The plasma osmolality and plasma triglyceride an indirect indicator of glycerol are confirmed by venous blood samples also at predetermined times after the last swallow of glycerol In addition the systemic blood pressure and the capillary blood glucose are monitored closely during the visit
Principles of material and methods A prospective randomized clinical trial on 15 patients with diabetic significant macular oedema At baseline the patients undergo a thorough ophthalmologic examination including ETDRS visual acuity slit lamp biomicroscopy Optical Coherence Tomography Stratus-OCT 7-field fundus photography followed by fluorescein angiography In addition the systemic blood pressure is measured and blood samples are taken to rule out severe renal insufficiency and to estimate glycosylated haemoglobin
The patients are all randomised to drink either 15 or 3 mL glycerolkg body weight max 250 mL pr day on the first of two visit dates The last dose is given at the second visit In the following three hours the retinal thickness is then monitored closely by Stratus-OCT after the glycerol ingestion
The plasma osmolality and plasma triglyceride an indirect indicator of glycerol are confirmed by venous blood samples also at predetermined times after the last swallow of glycerol In addition the systemic blood pressure and the capillary blood glucose are monitored closely during the visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None