The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000863831
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
15/08/2012
Date last updated
16/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes of total antioxidant capacity and total oxidant status of aqueous humor in different stages of diabetic retinopathy and non-diabetic patients.
Scientific title
Aqueous humor sampling during cataract surgery in diabetic retinopathy and non-diabetic patients and measuring total antioxidant capacity and total oxidant status of aqeous humor to define early diabetic retinopathy progression.
Secondary ID [1] 281025 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy 287158 0
Condition category
Condition code
Eye 287479 287479 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-Collecting aqueous humor during cataract surgery of diabetic retinopathy patients.
Aqueous humor collected just beginning of cataract surgery. corneal side insicion have been done with MVR knife and 0,1-,0,2 cc aqueous humor aspirated via 26 gauge insulin syringe then cataract surgery continued with the enjection of viscoelastic substance into anterior chamber.


2-Measuring Total antioxidant capacity and total oxidant status in collected aqueous humor.
Aqeous humor immediately stored at -80 celcius and all samples measured at the same time via Erel method. (at January 2011, one month before end of study)


Measurements of total antioxidant capacity and total oxidant status performed with Erel method. It is a new calorimetric method. This method spectrophotometrically measures changes of oxidant and antioxidant ions present in the sample.
Intervention code [1] 285485 0
Early detection / Screening
Comparator / control treatment
1-Collecting aqueous humor during cataract surgery of non-diabetic patients

2-Measuring Total antioxidant capacity and total oxidant status in collected aqueous humor
Control group
Active

Outcomes
Primary outcome [1] 287744 0
1- Total antioxidant status and total oxidant satus of all aqueous humor samples measured.
Measurements of total antioxidant capacity and total oxidant status performed via new calorimetric method known as Erel method.
Timepoint [1] 287744 0
1-At january 2011, at the end of data collection, one month before end of study.
Secondary outcome [1] 298761 0
1-Measured oxidative and antioxidative stress markers compared with diabetic retinopathy levels.

Statistical analysis was done via SPSS Windows 15.0 program.
Basicly Sperman and Pearson correlation tests were used for analysis.
Timepoint [1] 298761 0
1-at one month after data collection

Eligibility
Key inclusion criteria
Inclusion criteria included diabetic patients who had diagnosis of senile cataracts. For non-diabetic patients inclusion criteria was presence of cataract.
Minimum age
35 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included patients who had dense cataract which hinder retinopathy staging, previous ocular surgery, type 1 diabetes, history of glaucoma, retinal vein occlusion, uveitis, any other posterior segment pathologies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / 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] 4485 0
Turkey
State/province [1] 4485 0

Funding & Sponsors
Funding source category [1] 285811 0
Self funded/Unfunded
Name [1] 285811 0
Emrullah Beyazyildiz
Address [1] 285811 0
Ulucanlar Goz egitim ve arastirma hastanesi No: 59 Ankara
Country [1] 285811 0
Turkey
Primary sponsor type
Hospital
Name
Ulucanlar eye research and training hospital
Address
silahtar caddesi No:2 Gazi/Ankara
Country
Turkey
Secondary sponsor category [1] 284636 0
Hospital
Name [1] 284636 0
Numune research and training hospital
Address [1] 284636 0
Ulku mahallesi Talatpasa bulvari no:5 Altindag/Ankara
Country [1] 284636 0
Turkey

Ethics approval
Ethics application status
Approved

Summary
Brief summary
There are no sensitive markers that can predict or quantify total oxidant status and total antioxidant capacity in DR patients. The lack of reliable biomarkers prevents early, cost-effective measures to target those who might benefit from intensive diabetic therapy. We aimed to observe changes of total oxidant status (TOS) and total antioxidant capacity (TAC) of aqueous humor between stages of diabetic retinopathy patients. If these biomarkers works, it will be very usefull method to detect diabetic retinopathy progression risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34574 0
Address 34574 0
Country 34574 0
Phone 34574 0
Fax 34574 0
Email 34574 0
Contact person for public queries
Name 17821 0
Emrullah Beyazyildiz
Address 17821 0
Gazi Mustafa Kemal devlet hastanesi silahtar caddesi no:2
Gazi Mahallesi/Yenimahalle
Country 17821 0
Turkey
Phone 17821 0
+905057669783
Fax 17821 0
+903122126675
Email 17821 0
emrllh@yandex.com.tr
Contact person for scientific queries
Name 8749 0
Emrullah Beyazyildiz
Address 8749 0
Gazi Mustafa Kemal devlet hastanesi silahtar caddesi no:2
Gazi Mahallesi/Yenimahalle
Country 8749 0
Turkey
Phone 8749 0
+905057669783
Fax 8749 0
+903122126675
Email 8749 0
dremrullah@hotmail.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