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Trial registered on ANZCTR


Registration number
ACTRN12607000550404
Ethics application status
Approved
Date submitted
9/10/2007
Date registered
25/10/2007
Date last updated
25/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study of visual and refractive outcomes of conventional coaxial phacoemulsification and microincision coaxial phacoemulsification
Scientific title
Double blind randomized clinical trial of comparative study of surgically induced astigmatism, visual acuity, endothelial cell loss of conventional coaxial phacoemulsification and microincision coaxial phacoemulsification
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 2436 0
Cataract surgery 2465 0
Condition category
Condition code
Eye 2564 2564 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Microincision coaxial phacoemulsification: cataract surgery using phacoemulsification through 2.2 millimeters incision performed by Alcon Legacy machine.This procedure is done intra operatively
Intervention code [1] 2194 0
Treatment: Surgery
Comparator / control treatment
Conventional coaxial phacoemulsification: cataract surgery performed through 2.8 millimeters incision using Alcon Legacy machine.This procedure is done intra operatively
Control group
Active

Outcomes
Primary outcome [1] 3469 0
Surgically induced astigmatism/keratometry/topography
Timepoint [1] 3469 0
1 month after surgery, 3months after surgery
Secondary outcome [1] 5722 0
Visual acuity using "EDTRS" (early treatment diabetic retinopaty study) chart
Timepoint [1] 5722 0
First day, 3 days, 1 month, 3 months after surgery
Secondary outcome [2] 5723 0
Endothelial cell loss using specular microscopy
Timepoint [2] 5723 0
3 months after surgery
Secondary outcome [3] 5724 0
Corneal thickness using pachymetry
Timepoint [3] 5724 0
First day, 3 days, 1 months, 3 months after surgery
Secondary outcome [4] 5725 0
Time of surgery
Timepoint [4] 5725 0
Intra operative
Secondary outcome [5] 5726 0
Intra operative used BSS (Balanced Salt Solution) volume
Timepoint [5] 5726 0
Intra operatively
Secondary outcome [6] 5727 0
Corneal thickness using pachy metry
Timepoint [6] 5727 0
First day, 3 day ,1 month, 3 months after surgery
Secondary outcome [7] 5728 0
Effective phacoemulsification time
Timepoint [7] 5728 0
Intra operatively

Eligibility
Key inclusion criteria
Senile cataract, no history of ocular surgery,
no central corneal opacity, 7 milimeters or more pupil dilatation in preoperative exam, normal fundus exam, endothelial cell count more than 1600
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
More than 3 diopters astigmaism, expected visual scuity less than 20/40, zonulolysis, diabetes mellitus or other known metabolic disorders, pupil anomalies or posterior synechia, ocular disorders such as glaucoma, optic atrophy or intra ocular tumors
any drug abuse,
use of systemic corticosteroids or NSAIDS (non steroidal antiinflammatory drugs )since 1 month of surgery,
corneal opacity,
anyrenal ,hepatic ,endocrine ,pulmunar ,rheumatologic, neurologic and psycologic disorders

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 envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 620 0
Iran, Islamic Republic Of
State/province [1] 620 0

Funding & Sponsors
Funding source category [1] 2686 0
University
Name [1] 2686 0
Tehran University of Medical Science
Country [1] 2686 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran university of medical science
Address
Tehran University of Medical Science
Enghelab Street
Tehran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 2430 0
Hospital
Name [1] 2430 0
Noor Ophthalmology Research Center
Address [1] 2430 0
No 106 Esfandiar Blvd.
Vali'asr Ave.
Tehran
Country [1] 2430 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 28100 0
Address 28100 0
Country 28100 0
Phone 28100 0
Fax 28100 0
Email 28100 0
Contact person for public queries
Name 11257 0
Narges Zandvakil
Address 11257 0
Farabi Eye Hospital
Ghazvin Sq
Karegar Ave
Tehran
Country 11257 0
Iran, Islamic Republic Of
Phone 11257 0
+98 21 88697000
Fax 11257 0
Email 11257 0
zandvakil@razi.tums.ac.ir
Contact person for scientific queries
Name 2185 0
Narges Zandvakil
Address 2185 0
Farabi Eye Hospital
Ghazvin Sq
Karegar Ave
Tehran
Country 2185 0
Iran, Islamic Republic Of
Phone 2185 0
+98 21 88697000
Fax 2185 0
Email 2185 0
zandvakil@razi.tums.ac.ir

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.