Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000050055
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
18/01/2010
Date last updated
18/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
laser correction of far sightness using different laser parameters
Scientific title
Correlation of refractive outcomes with increasing optical zone diameter in hyperopic Lasik in patients with bilateral hyperopia
Secondary ID [1] 1292 0
None
Universal Trial Number (UTN)
U1111-1113-3327
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyper metropia 256541 0
Condition category
Condition code
Eye 256714 256714 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hyperopic lasik correction for hyperopia more than +4 diopters using 2 optical zones diameter ,6 mm and 6.5 mm. we compare the 6.5 mm to the standdred 6.00 mm regarding efficacy,stability and saftey. this is a one off intervention and each patient is his own controll
Intervention code [1] 255818 0
Treatment: Other
Comparator / control treatment
The comparator is the fellow eye of the same patient receiving 6.0 mm optical zone diameter.
Control group
Active

Outcomes
Primary outcome [1] 257599 0
Patients refraction in diopters as a measure of predictability of the treatment (1 ry outcome). This is measured by objective cycloplegic refraction by retinoscopy a and verified by subjective refraction and measurement of visual acuity using the snellens chart
Timepoint [1] 257599 0
one week post treatment
Secondary outcome [1] 262870 0
Patients refraction in diopters after 6 months as a measure of stability of the treatment (2ry outcome.This is measured by objective cycloplegic refraction by retinoscopy a and verified by subjective refraction and measurement of visual acuity using the snellens chart
Timepoint [1] 262870 0
6 months post treatment

Eligibility
Key inclusion criteria
Bilateral hyperopia > 4 diopters.
Minimum age
29 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Amblyopia
central keratometry >45 diopters
central pcchymetry < 500 microns
associated ocular disease as glaucoma , cataract corneal dystrophies and retinal diseases

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)
patients were assigned to do a bilateral hyper opic lasik.
The rigth eyes of all patients had a 6 mm diameter optical zone treatment. while left eyes recieved a 6.5 mm optical zone diameter treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 2405 0
Egypt
State/province [1] 2405 0

Funding & Sponsors
Funding source category [1] 256310 0
Self funded/Unfunded
Name [1] 256310 0
Mostaf A EL-Helw
Country [1] 256310 0
Egypt
Primary sponsor type
Individual
Name
Mostaf A EL-Helw
Address
52 Manyal street, Manyal 11451
Cairo, Egypt
Country
Egypt
Secondary sponsor category [1] 251629 0
Hospital
Name [1] 251629 0
Al-Nour eye Hospital
Address [1] 251629 0
93 Mostafa El Nahas street. Nasr city,
Cairo, Egypt
Country [1] 251629 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258392 0
Al-Nour eye hospital ethical committe
Ethics committee address [1] 258392 0
Ethics committee country [1] 258392 0
Egypt
Date submitted for ethics approval [1] 258392 0
Approval date [1] 258392 0
15/04/2008
Ethics approval number [1] 258392 0

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

Contacts
Principal investigator
Name 30702 0
Address 30702 0
Country 30702 0
Phone 30702 0
Fax 30702 0
Email 30702 0
Contact person for public queries
Name 13949 0
Mostafa Aly EL-Helw
Address 13949 0
52 manyal street, manyal 11451
Cairo, Egypt
Country 13949 0
Egypt
Phone 13949 0
+20101228920
Fax 13949 0
Email 13949 0
[email protected]
Contact person for scientific queries
Name 4877 0
Mostafa Aly EL-Helw
Address 4877 0
52 manyal street, manyal 11451
Cairo, Egypt
Country 4877 0
Egypt
Phone 4877 0
+20101228920
Fax 4877 0
Email 4877 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.