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Trial registered on ANZCTR
Registration number
ACTRN12613000433707
Ethics application status
Approved
Date submitted
14/04/2013
Date registered
17/04/2013
Date last updated
18/04/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of Ocular Angiography on Intraocular Pressure in Diabetic Patients
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Scientific title
Effects of Fundus Fluorescein Angiography Procedure on Intraocular Pressure and Ocular Pulse Amplitude in Non-Proliferative Diabetic Retinopathy Patients
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Secondary ID [1]
282333
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non - proliferative diabetic retinopathy
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Condition category
Condition code
Eye
289223
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0
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Diseases / disorders of the eye
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Metabolic and Endocrine
289239
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Florescein angiography
(Fluorescite 10% 5 ml Alcon Lab.)
intravenous administration (only once)
Duration of Fundus Fluorescein Angiography (FFA) procedure: 10 minutes
Duration of intravenous fluorescein injection: 2 seconds
FFA procedure occurs after 10 seconds from intravenous fluorescein injection
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Intervention code [1]
286948
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Diagnosis / Prognosis
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Comparator / control treatment
The measurements were done before and after the fluorescein angiography in the same group (diabetic patients)
This is a single group uncontrolled study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Intraocular pressure
Intraocular pressure (IOP) measurements were done with the Pascal dynamic contour tonometer (Pascal DCT, Swiss Microtechnology AG, Port, Switzerland). This is a slit-lamp biomicroscopy mounted, self-calibrating, 7-mm tip diameter, and 1.2-mm pressure sensor diameter device.
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Assessment method [1]
289336
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Timepoint [1]
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5 minutes after intravenous fluorescein dye injection
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Primary outcome [2]
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Ocular pulse amplitude
Ocular pulse amplitude measurements were done with the Pascal dynamic contour tonometer (Pascal DCT, Swiss Microtechnology AG, Port, Switzerland).
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Assessment method [2]
289337
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Timepoint [2]
289337
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5 minutes after intravenous fluorescein dye injection
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Secondary outcome [1]
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intraocular pressure gender difference
This outcome was assessed by Pascal dynamic contour tonometer.
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Assessment method [1]
302259
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Timepoint [1]
302259
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5 minutes after intravenous fluorescein dye injection
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Secondary outcome [2]
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ocular pulse amplitude gender difference
This outcome was assessed by Pascal dynamic contour tonometer.
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Assessment method [2]
302260
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Timepoint [2]
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5 minutes after intravenous fluorescein dye injection
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Eligibility
Key inclusion criteria
Non-proliferative diabetic retinopathy patients
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Minimum age
47
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Having any ocular disease other than non - proliferative diabetic retinopathy
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
paired samples t-test
Sample size was determined by looking at the t-test sample size table (alpha:0.05, beta:0.10, influence quantity:0.80). Also sample size was adjusted in order to perform a parametric statistical analysis.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
10/01/2013
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Actual
11/01/2013
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Date of last participant enrolment
Anticipated
1/03/2013
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Actual
1/03/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5017
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Turkey
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State/province [1]
5017
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Pamukkale University
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Address [1]
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Camlaralti Mah., Kinikli, Denizli (postcode:20070)
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Country [1]
287089
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Turkey
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Primary sponsor type
Individual
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Name
Gokhan Pekel
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Address
Camlaralti Mah., Kinikli, Pamukkale University, Ophthalmology Department, Denizli (postcode:20070)
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Country
Turkey
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Secondary sponsor category [1]
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Individual
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Name [1]
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Ramazan Yagci
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Address [1]
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Camlaralti Mah., Kinikli, Pamukkale University, Ophthalmology Department, Denizli (postcode:20070)
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Country [1]
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Pamukkale University Ethics Committee
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Ethics committee address [1]
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Pamukkale University Faculty of Medicine, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
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Ethics committee country [1]
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Turkey
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Date submitted for ethics approval [1]
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14/12/2012
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Approval date [1]
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25/12/2012
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Ethics approval number [1]
289105
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Summary
Brief summary
In this study, we evaluated the effects of fundus fluorescein angiography procedure, which has been performed for nearly 50 years in order to diagnose retina - choroidal diseases, on intraocular pressure and ocular pulse amplitude in non - proliferative diabetic patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Gokhan Pekel
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Address
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Pamukkale University, Faculty of Medicine, Ophthalmology Department, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
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Country
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Turkey
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Phone
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+90 258 4440728 - 5785
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Gokhan Pekel
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Address
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Pamukkale University, Faculty of Medicine, Ophthalmology Department, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
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Country
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Turkey
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Phone
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+90 258 4440728 - 5785
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Gokhan Pekel
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Address
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Pamukkale University, Faculty of Medicine, Ophthalmology Department, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
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Country
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Turkey
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Phone
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+90 258 4440728 - 5785
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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