Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001042235
Ethics application status
Approved
Date submitted
26/11/2009
Date registered
7/12/2009
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical study of vitreous surgery with direct central retinal artery massage for the treatment of central retinal artery occlusion
Scientific title
In patients with central retinal artery occlusion, is vitreous surgery with direct central retinal artery massage superior to traditional treatment in improving circulation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
central retinal artery occlusion 252296 0
Condition category
Condition code
Surgery 252477 252477 0 0
Surgical techniques
Eye 252507 252507 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After standard 3 port pars plana vitrectomy(PPV),a probe specialy desinged for the surgery was used to penitrate into the optic nerve head along the central retinal artery, at the same time, diretcly massaging along the central retinal artery wall (5-6 times, about 3 minutes).If the circulation did not recover, then a scleral depressor was used to press the optic nerve slightly retrobulbarly 5-6 times (about 2 minutes).
Intervention code [1] 241614 0
Treatment: Surgery
Comparator / control treatment
central retinal artery occlusion with traditional treatments:ocular massage for 20 minutes, sublingual isosorbide dinitrate 10 mg and oral acetazolamide 500 mg daily for 3-4 days, oral asparine 100mg daily for at least 2 months.
Control group
Active

Outcomes
Primary outcome [1] 253354 0
circulation recovery is accessed by observing the vessel caliber of the retina by ophthalmoscope and fluorescein angiography
Timepoint [1] 253354 0
immedietly after operation, 1 or 2 days after operation, 1 months and 2 months after operation
Primary outcome [2] 253355 0
retinal edema decrease is accessed by observing the color of the retina and fluorescein angiography
Timepoint [2] 253355 0
one week , 2 weeks and 3 weeks after operation
Secondary outcome [1] 262441 0
visual acuity recovery (Snellen eye chart.)
Timepoint [1] 262441 0
1 week , 1 month and 2 months after operation

Eligibility
Key inclusion criteria
tipical central retinal artery occlusion occurred within 4 days
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
with other eye diseases that affect vision

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After the diagnosis of central retinal artery occlusion was made, a detailed explanation of the possible results of the surgery and traditional treatment ( including all the complications) was made. Then the patients were asked to select one of the treatments
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
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2343 0
China
State/province [1] 2343 0
Beijing

Funding & Sponsors
Funding source category [1] 256094 0
Hospital
Name [1] 256094 0
Beijing Tongren Eye Center
Country [1] 256094 0
China
Primary sponsor type
Hospital
Name
Beijing Tongren Eye Center
Address
Dongjiao Min Xiang No.1, East City District, Beijing
Country
China
Secondary sponsor category [1] 251437 0
None
Name [1] 251437 0
Address [1] 251437 0
Country [1] 251437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258183 0
Beijing Tongren Hospital
Ethics committee address [1] 258183 0
Dongjiao Min Xiang No.1, East City District, Beijing
Ethics committee country [1] 258183 0
China
Date submitted for ethics approval [1] 258183 0
Approval date [1] 258183 0
01/01/2005
Ethics approval number [1] 258183 0

Summary
Brief summary
The purpose of the study is to evaluate the effect and safty of vitreous surgery with direct central retinal artery massage for central retinal artery occlusion. Pressing the central retinal artery in the optic nerve head
with a probe or retrobulbarly with a sclera
depressor led to deformation and bending of the blood vessel wall. During the mechanical movement of the vessels
induced by the probe, the embolus may be
broken into smaller pieces and then be dislodged, followed by curculation recovery. More than 15 cases received the sugical treatment, and more than 100 patients received the traditional treatments.
Trial website
Trial related presentations / publications
Vitreous surgery with direct central retinal artery massage for central retinal artery occlusion.Eye (Lond). 2009 Apr;23(4):867-72. Epub 2008 May 16.
Public notes

Contacts
Principal investigator
Name 30556 0
Address 30556 0
Country 30556 0
Phone 30556 0
Fax 30556 0
Email 30556 0
Contact person for public queries
Name 13803 0
Hong-shu Zhao
Address 13803 0
Dongjiao Min Xiang No.1,East City District, Beijing
Country 13803 0
China
Phone 13803 0
086-010-58269508
Fax 13803 0
86-010-65131244
Email 13803 0
hongshuz@yahoo.com.cn
Contact person for scientific queries
Name 4731 0
Hong-shu Zhao
Address 4731 0
Dongjiao Min Xiang No.1,East City District, Beijing
Country 4731 0
China
Phone 4731 0
086-010-58269508
Fax 4731 0
86-010-65131244
Email 4731 0
hongshuz@yahoo.com.cn

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No Supporting Document Provided



Results publications and other study-related documents

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