Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000057088
Ethics application status
Approved
Date submitted
18/01/2010
Date registered
19/01/2010
Date last updated
19/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing 2 different methods for correction of very high degrees of short sightness. by either exchanging the normal lens with an aritifical one or implanting an artificial lens on top of the natural one
Scientific title
Comparison of Clear Lens extraction and Intraocular contact lens implantation in the treatment of high myopia regarding saftey and accuracy
Secondary ID [1] 1303 0
None
Universal Trial Number (UTN)
U1111-1113-3781
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Myopia 256569 0
Condition category
Condition code
Eye 256740 256740 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Myopics younger than 40 years old with more than 12 dioptres of myopia or who were not fit for Lassie assisted in situ keratomieusis (LASIK) were included . Group A was the Clear lens extraction with foldable intraocular lens implantation this is a one off intervention lasting approximately one half hour, and Group B was the Visian intra ocular contact lens (ICL) implantation this is a one off intervention lasting approximately one half hour . Patients were evaluated for visual and anatomic outcome, and complications
Intervention code [1] 255839 0
Treatment: Surgery
Comparator / control treatment
The 2 groups were compared to each other
Control group
Active

Outcomes
Primary outcome [1] 257626 0
Patients subjective and objective refraction measured in diopters using the retinoscope and autorefractor. and verified by visual acuity testing using the snellens chart
Timepoint [1] 257626 0
2 weeks post surgery
Secondary outcome [1] 262899 0
saftey of the procedure regarding retinal problems or intra ocular infections in group1
in group 2 complications as cataract ,glaucoma
these outcome are detected and measured by clinical examination by the slit lamp and ophthalmoscope
Timepoint [1] 262899 0
one year post surgery

Eligibility
Key inclusion criteria
-Myopia more than 12 diopters,
-Myopia of less than 12 diopters if the patients were unsuitable for LASIK due to topography or pachymetry results,
-Age less than 45 years
Minimum age
21 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
_ Intraocular Pressure (IOP) outside the statistically normal range (more than 21 mmHg),
-Presence of iris transillumination defects,
-Retinal pathology

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 with high myopia >12 diopters who were motivated to correct their condition.
were assigned to either group depending on their ocular condition,
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
Active, not recruiting
Date of first participant enrolment
Anticipated
22/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2415 0
Egypt
State/province [1] 2415 0

Funding & Sponsors
Funding source category [1] 256329 0
Hospital
Name [1] 256329 0
Al-Nour eye hospital
Country [1] 256329 0
Egypt
Primary sponsor type
Hospital
Name
Al-Nour eye hospital
Address
93 Mostafa EL-Nahas street nasr city,11371
Cairo,Egypt
Country
Egypt
Secondary sponsor category [1] 251647 0
Individual
Name [1] 251647 0
Mostafa Aly EL-Helw
Address [1] 251647 0
52 Manyal street,Manyal 11451
Cairo,Egypt
Country [1] 251647 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258410 0
Al-Nour eye hospital ethical committe
Ethics committee address [1] 258410 0
Ethics committee country [1] 258410 0
Egypt
Date submitted for ethics approval [1] 258410 0
Approval date [1] 258410 0
29/10/2005
Ethics approval number [1] 258410 0

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

Contacts
Principal investigator
Name 30720 0
Address 30720 0
Country 30720 0
Phone 30720 0
Fax 30720 0
Email 30720 0
Contact person for public queries
Name 13967 0
Mostafa Aly EL-Helw
Address 13967 0
52 Manyal street,Manyal 11451
Cairo,Egypt
Country 13967 0
Egypt
Phone 13967 0
+20101228920
Fax 13967 0
Email 13967 0
[email protected]
Contact person for scientific queries
Name 4895 0
Ahmed M Emarah
Address 4895 0
6 hegaz street, heliopolis 11341
Cairo,Egypt
Country 4895 0
Egypt
Phone 4895 0
+20122235511
Fax 4895 0
Email 4895 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.