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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
Scientific title
Effects of Fundus Fluorescein Angiography Procedure on Intraocular Pressure and Ocular Pulse Amplitude in Non-Proliferative Diabetic Retinopathy Patients
Secondary ID [1] 282333 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non - proliferative diabetic retinopathy 288880 0
Condition category
Condition code
Eye 289223 289223 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 289239 289239 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 286948 0
Diagnosis / Prognosis
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
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289336 0
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.
Timepoint [1] 289336 0
5 minutes after intravenous fluorescein dye injection
Primary outcome [2] 289337 0
Ocular pulse amplitude
Ocular pulse amplitude measurements were done with the Pascal dynamic contour tonometer (Pascal DCT, Swiss Microtechnology AG, Port, Switzerland).
Timepoint [2] 289337 0
5 minutes after intravenous fluorescein dye injection
Secondary outcome [1] 302259 0
intraocular pressure gender difference
This outcome was assessed by Pascal dynamic contour tonometer.
Timepoint [1] 302259 0
5 minutes after intravenous fluorescein dye injection
Secondary outcome [2] 302260 0
ocular pulse amplitude gender difference
This outcome was assessed by Pascal dynamic contour tonometer.
Timepoint [2] 302260 0
5 minutes after intravenous fluorescein dye injection

Eligibility
Key inclusion criteria
Non-proliferative diabetic retinopathy patients
Minimum age
47 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having any ocular disease other than non - proliferative diabetic retinopathy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5017 0
Turkey
State/province [1] 5017 0

Funding & Sponsors
Funding source category [1] 287089 0
University
Name [1] 287089 0
Pamukkale University
Address [1] 287089 0
Camlaralti Mah., Kinikli, Denizli (postcode:20070)
Country [1] 287089 0
Turkey
Primary sponsor type
Individual
Name
Gokhan Pekel
Address
Camlaralti Mah., Kinikli, Pamukkale University, Ophthalmology Department, Denizli (postcode:20070)
Country
Turkey
Secondary sponsor category [1] 285865 0
Individual
Name [1] 285865 0
Ramazan Yagci
Address [1] 285865 0
Camlaralti Mah., Kinikli, Pamukkale University, Ophthalmology Department, Denizli (postcode:20070)
Country [1] 285865 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289105 0
Pamukkale University Ethics Committee
Ethics committee address [1] 289105 0
Pamukkale University Faculty of Medicine, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
Ethics committee country [1] 289105 0
Turkey
Date submitted for ethics approval [1] 289105 0
14/12/2012
Approval date [1] 289105 0
25/12/2012
Ethics approval number [1] 289105 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39270 0
A/Prof Gokhan Pekel
Address 39270 0
Pamukkale University, Faculty of Medicine, Ophthalmology Department, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
Country 39270 0
Turkey
Phone 39270 0
+90 258 4440728 - 5785
Fax 39270 0
Email 39270 0
gkhanpekel@yahoo.com
Contact person for public queries
Name 39271 0
A/Prof Gokhan Pekel
Address 39271 0
Pamukkale University, Faculty of Medicine, Ophthalmology Department, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
Country 39271 0
Turkey
Phone 39271 0
+90 258 4440728 - 5785
Fax 39271 0
Email 39271 0
gkhanpekel@yahoo.com
Contact person for scientific queries
Name 39272 0
A/Prof Gokhan Pekel
Address 39272 0
Pamukkale University, Faculty of Medicine, Ophthalmology Department, Camlaralti Mah., Kinikli, Denizli (postcode:20070)
Country 39272 0
Turkey
Phone 39272 0
+90 258 4440728 - 5785
Fax 39272 0
Email 39272 0
gkhanpekel@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary