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Trial registered on ANZCTR


Registration number
ACTRN12610001053011
Ethics application status
Not yet submitted
Date submitted
25/11/2010
Date registered
1/12/2010
Date last updated
1/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgery for intermittent Divergent squint: A Comparison of Outcomes Following Two Different Surgical Techniques
Scientific title
Surgery for intermittent Exotropia: A Comparison of Outcomes Following Two Different Surgical Techniques
Secondary ID [1] 253175 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Divergent squint [ intermittent exotropia] 258717 0
Condition category
Condition code
Eye 258871 258871 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery for intermittent exotropia, Bilateral lateral recti recession or recession/ resection. the recession of the lateral recti muscle involves weakening the muscle by pulling it back few mm [ each mm will weaken the muscle by 3 diopters] so the amount will depend on the degree of divergent squint. e.g to correct 30 diopters of divergent squint will need to weaken each lateral recti muscle by 5 mm on each side so in total 10 mm = 30 Diopters.
for the medial rectus resection means strengthening the muscle by cutting it { each mm will strengthen the muscle by 4 mm] and that is again depend on the amount of squint.
the duration of each procedure will be approximately 20 min / muscle.
Intervention code [1] 257669 0
Treatment: Surgery
Comparator / control treatment
Active control, lateral recti recession procedure is the standard procedure for the intermittent divegernt squint. however some advocate recession/ resection procedure. so the aim is to compare the outcome of both techniques.
Control group
Active

Outcomes
Primary outcome [1] 259731 0
Comparison between two techniques for intermittent exotropia.,{Bilateral lateral recti reccession or medial/ lateral rectus recession/ resection regarding the success rate. and this is measured by diopter [ the surgery considered successful if the residul squint is less than 10 Diopters
Timepoint [1] 259731 0
At 2 years after randomization
Secondary outcome [1] 266464 0
Does the patch test alter the distance measurements and therefore the surgical target the effect of patch test.
we patch the involved eye for 20, 40 ,60 min at different intervals and do measure amount of squint in diopters
Timepoint [1] 266464 0
At 2 years after randomization

Eligibility
Key inclusion criteria
Age 3-18 years
History of intermittent exotropia intermittent at either near or distance
Full eye movements
Visual acuity 6/9 or better each eye best corrected with crowded test by the time of surgery
Any myopic refractive error, anisometropia or astigmatism of 1 dioptre or greater or hyperopia which is reducing the vision to less than 6/9 must be treated prior to inclusion.
Basic exotropia with difference between near and distance measurements <10 dioptres, or simulated divergence excess with difference between near and distance measurement <10 dioptres after +3.00 test and/or patch test.
Able to obtain full informed consent from the family for randomisation
Able to obtain accurate prism cover test measurements (distance and near cover test within 5^ on at least 2 visits)
Minimum age
3 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to obtain accurate prism cover test measurement
Convergence insufficiency exotropia or true divergence excess
Anyone with neurological/systemic abnormalities as the surgical result can be unpredictable
Anyone requiring oblique muscle surgery
Previous eye muscle surgery
Adjustables
“A” greater than 10 or “ V” greater than 15dioptres
Anyone unwilling to be randomized

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)
Patients have intermittent exotropia who need surgical intervention and have been referred to the eye clinic by ophthalmologist or orthoptist will be randomized to treatment and allocation is concealed via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients with intermittent divergent squint who need surgery will be randomized [via computerized sequence generation ] into 2 groups : group one will have bilateral ( both right and left eye) lateral rect recession. group 2 will have lateral rectus recession and medial rectus resection on the same eye.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 3069 0
New Zealand
State/province [1] 3069 0

Funding & Sponsors
Funding source category [1] 258145 0
Hospital
Name [1] 258145 0
Auckland District health board
Country [1] 258145 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District health board
Address
Greenlane clinical center
Green lane west 1051
Auckland
Country
New Zealand
Secondary sponsor category [1] 257312 0
Hospital
Name [1] 257312 0
Green lane clinical centre.
Address [1] 257312 0
Green lane clinical centre, greenlane west 1051 Auckland
Country [1] 257312 0
New Zealand
Secondary sponsor category [2] 257333 0
Hospital
Name [2] 257333 0
Auckland eye Hospital
Address [2] 257333 0
8 Mark street
Remuera, Auckland P O Box 99311, Newmarket,
Auckland, NZ
Country [2] 257333 0
New Zealand
Secondary sponsor category [3] 257334 0
Hospital
Name [3] 257334 0
Ascot Hospital, Remuera
Address [3] 257334 0
90 Greenlane Road East, Remuera
Auckland
posta address:
Private Bag Remuera
Auckland
Country [3] 257334 0
New Zealand
Secondary sponsor category [4] 257335 0
Hospital
Name [4] 257335 0
Super-clinic , CMHB.
Address [4] 257335 0
901 Great south Rd, Auckland,
PO Box 98743 Manukau City
Manukau 2241
Auckland
Country [4] 257335 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260123 0
Ethics committee address [1] 260123 0
Ethics committee country [1] 260123 0
Date submitted for ethics approval [1] 260123 0
01/12/2010
Approval date [1] 260123 0
Ethics approval number [1] 260123 0

Summary
Brief summary
the aim of this study is :
1. To compare BLR recession and recess/resect for basic (N=D angle) intermittent exotropia
2. To compare BLR recession and recess/resect for and simulated divergence (N=D with +3’s)
3. To assess 20, 40, 60 mins patch tests to determine whether these are equivalent.
4. Does the patch test alter the distance measurements and therefore the surgical target
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 31957 0
Address 31957 0
Country 31957 0
Phone 31957 0
Fax 31957 0
Email 31957 0
Contact person for public queries
Name 15204 0
Rasha Altaie
Address 15204 0
Department of ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 15204 0
New Zealand
Phone 15204 0
0064 21220 586
Fax 15204 0
Email 15204 0
[email protected]
Contact person for scientific queries
Name 6132 0
Rasha Altaie
Address 6132 0
Department of ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 6132 0
New Zealand
Phone 6132 0
0064 21220 586
Fax 6132 0
Email 6132 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.