Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000875101
Ethics application status
Approved
Date submitted
3/06/2019
Date registered
19/06/2019
Date last updated
19/06/2019
Date data sharing statement initially provided
19/06/2019
Date results provided
19/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Toric phakic intraocular lens implantation in eyes with astigmatism using image guided system.
Scientific title
Evaluation of axis alignment and Refractive results of Toric Phakic IOL using Image- Guided System in patients with moderate to high astigmatism.
Secondary ID [1] 298400 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Astigmatism 313097 0
Condition category
Condition code
Eye 311579 311579 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
toric phakic posterior lens implantation to correct astigmatism
done by surgeons who have at least 20 years of experience. The approximate duration of surgery is 10 minutes for each eye. operation was done in the OR of an eye hospital.The current V4C ICL design was used. Under local anesthesia, dilating agents were administered. Preoperative digital reference imaging was obtained by Verion unit. In a temporal approach, after injection of viscoelastic material (Provisc, Alcon), a small 3.2 mm clear corneal incision was made and the ICL was injected through this incision into the anterior chamber and allowed to slowly unfold.After the injection and unfolding of the toric ICL into the anterior chamber, haptics were tucked under the iris. TICL was aligned to the desired axis by the guide of VERION digital marking.
Intervention code [1] 314644 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320285 0
toric ICL axis alignment evaluated by OPD machine
Timepoint [1] 320285 0
one week post operative
Secondary outcome [1] 371077 0
visual acuity with logMAR chart
Timepoint [1] 371077 0
one week postoperative
Secondary outcome [2] 371078 0
residual astigmatism with manifest refraction
Timepoint [2] 371078 0
one week postoperative

Eligibility
Key inclusion criteria
patients age 21 to 45 years old
astigmatism more than 1.5 D
free from other eye diseases
Minimum age
21 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients younger than 21 according to manufacturer recommendation
patients with cataract or retina disease that can affect visual outcome
patients with AC depth less than 3 mm and WtW less than 10.6 mm or endothelial cell count less than 2000 cells / mm3

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



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
18/09/2017
Date of last participant enrolment
Anticipated
Actual
1/05/2019
Date of last data collection
Anticipated
15/08/2019
Actual
Sample size
Target
30
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 21555 0
United Arab Emirates
State/province [1] 21555 0
Dubai

Funding & Sponsors
Funding source category [1] 302941 0
Hospital
Name [1] 302941 0
Magrabi eye hospital
Country [1] 302941 0
United Arab Emirates
Primary sponsor type
Hospital
Name
Magrabi eye hospital
Address
Dubai health care city
Magrabi eye hospital
ALRAzi building #64 Block E 2nd floor
Dubai-UAE
Country
United Arab Emirates
Secondary sponsor category [1] 302904 0
Individual
Name [1] 302904 0
Sherif Emerah
Address [1] 302904 0
Dubai health care city
Magrabi eye hospital
ALRAzi building #64 Block E 2nd floor
Dubai-UAE
Country [1] 302904 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303503 0
Magrabi eye hospital ethics committee
Ethics committee address [1] 303503 0
Ethics committee country [1] 303503 0
United Arab Emirates
Date submitted for ethics approval [1] 303503 0
01/08/2017
Approval date [1] 303503 0
04/09/2017
Ethics approval number [1] 303503 0

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

Contacts
Principal investigator
Name 93890 0
Dr Sherif Emerah
Address 93890 0
Dubai health care city
ALRazi building #64
Block E
2nd floor
Magrabi eye hospital
Country 93890 0
United Arab Emirates
Phone 93890 0
+971566538724
Fax 93890 0
Email 93890 0
[email protected]
Contact person for public queries
Name 93891 0
Sherif Emerah
Address 93891 0
Dubai health care city
ALRazi building #64
Block E
2nd floor
Magrabi eye hospital
Country 93891 0
United Arab Emirates
Phone 93891 0
+971566538724
Fax 93891 0
Email 93891 0
[email protected]
Contact person for scientific queries
Name 93892 0
Sherif Emerah
Address 93892 0
Dubai health care city
ALRazi building #64
Block E
2nd floor
Magrabi eye hospital
Country 93892 0
United Arab Emirates
Phone 93892 0
+971566538724
Fax 93892 0
Email 93892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Emerah S. Evaluation of axis alignment and refract... [More Details] 377708-(Uploaded-20-05-2020-11-06-09)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEvaluation of axis alignment and refractive results of toric phakic IOL using image-guided system2020https://doi.org/10.18240/ijo.2020.04.21
N.B. These documents automatically identified may not have been verified by the study sponsor.