Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000775718
Ethics application status
Approved
Date submitted
8/07/2013
Date registered
11/07/2013
Date last updated
11/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of enoxaparin-containing irrigation fluid during cataract surgery on post-operative inflammation in patients with diabetes
Scientific title
The effect of enoxaparin-containing irrigation fluid during cataract surgery on post-operative inflammation in patients with diabetes; a randomized controlled clinical trial
Secondary ID [1] 282795 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative inflammation after cataract surgery in patients with diabetes 289568 0
Condition category
Condition code
Eye 289896 289896 0 0
Diseases / disorders of the eye
Surgery 289902 289902 0 0
Other surgery
Metabolic and Endocrine 289903 289903 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1; Drug: Enoxaparin. It is administered during the cataract surgery. The mode of the administration is intraocular infusion.

Enoxaparin 40 mg/500 ml in Balanced Salt Solution
Other name: clexane (Aventis)
Intervention code [1] 287480 0
Treatment: Drugs
Comparator / control treatment
Arm 2; Balanced Salt Solution is used for the intraocular infusion during the cataract surgery.

Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eye.

Balanced Salt Solution is a sterile solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2·6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2·3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7·2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

Intraocular infusion of Balanced Salt Solution
Other name:BSS
Control group
Placebo

Outcomes
Primary outcome [1] 289957 0
Anterior segment inflammation.
This is assessed by slit-lamp biomicroscopy.
Timepoint [1] 289957 0
Time frame: 1week
Secondary outcome [1] 303660 0
Anterior segment inflammation
This is assessed by slit-lamp biomicroscopy.
Timepoint [1] 303660 0
Time frame: 1month, 2 months

Eligibility
Key inclusion criteria
The study included non-insulin-dependent diabetes mellitus (NIDDM) patients that had moderate non-proliferative diabetic retinopathy (NPDR) according to Early Treatment Diabetic Retinopathy Study (ETDRS) and had grade 2-3 nuclear cataracts based on the classification of Lens Opacity Classification System III (LOCS III)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who underwent laser photocoagulation in the previous three months and patients with small pupils, posterior synechia and history of uveitis were excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation; coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the absence of available literature, we used data from a pilot study of 10 patients (10 eyes in each group) to arrive the sample size. The main outcome measure was the presence of grade 2 anterior chamber cells in the first week after the surgery. In the first week, cells with grade 2 were seen 10% of the eyes in group1 (enoxaparin group), 50% of the eyes in group 2 (no enoxaparin group). To detect the difference of 35% between two groups, using the test of proportions at 5% level of significance, a sample size of 30 in each group was necessary to achieve 80% power

Mann-Whitney U test and the chi-square test are used to investigate differences in terms of gender and age. Fisher's exact test, chi-square test and Mann-Whitney U test are used to compare post-operative inflammation between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2010
Actual
11/08/2010
Date of last participant enrolment
Anticipated
28/09/2012
Actual
23/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5169 0
Turkey
State/province [1] 5169 0
Hatay

Funding & Sponsors
Funding source category [1] 287573 0
Self funded/Unfunded
Name [1] 287573 0
None
Country [1] 287573 0
Primary sponsor type
Individual
Name
Ozgur Ilhan
Address
Mustafa Kemal University, Faculty of Medicine, Tayfur Ata Sokmen Campus, 31120, Serinyol, Antakya, Hatay
Country
Turkey
Secondary sponsor category [1] 286324 0
None
Name [1] 286324 0
None
Address [1] 286324 0
None
Country [1] 286324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289548 0
The Ethics Committee of the Medical Faculty of the Mustafa Kemal University
Ethics committee address [1] 289548 0
Ethics committee country [1] 289548 0
Turkey
Date submitted for ethics approval [1] 289548 0
21/05/2010
Approval date [1] 289548 0
11/06/2010
Ethics approval number [1] 289548 0
None

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41282 0
Dr Ozgur Ilhan
Address 41282 0
Mustafa Kemal University, Faculty of Medicine, Department of Ophthalmology, Tayfur Ata Sokmen Campus, 31120 Serinyol, Antakya, Hatay
Country 41282 0
Turkey
Phone 41282 0
+90 326 2291000
Fax 41282 0
Email 41282 0
[email protected]
Contact person for public queries
Name 41283 0
Ozgur Ilhan
Address 41283 0
Mustafa Kemal University, Faculty of Medicine, Department of Ophthalmology, Tayfur Ata Sokmen Campus, 31120 Serinyol, Antakya, Hatay
Country 41283 0
Turkey
Phone 41283 0
+90 326 2291000
Fax 41283 0
Email 41283 0
[email protected]
Contact person for scientific queries
Name 41284 0
Ozgur Ilhan
Address 41284 0
Mustafa Kemal University, Faculty of Medicine, Department of Ophthalmology, Tayfur Ata Sokmen Campus, 31120 Serinyol, Antakya, Hatay
Country 41284 0
Turkey
Phone 41284 0
+90 326 2291000
Fax 41284 0
Email 41284 0
[email protected]

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.