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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 21555 0
United Arab Emirates
State/province [1] 21555 0

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

Ethics approval
Ethics application status
Ethics committee name [1] 303503 0
Magrabi eye hospital ethics committee
Ethics committee address [1] 303503 0
Dubai health care city
ALRazi building #64 Block E 2nd floor
Magrabi eye hospital
Ethics committee country [1] 303503 0
United Arab Emirates
Date submitted for ethics approval [1] 303503 0
Approval date [1] 303503 0
Ethics approval number [1] 303503 0

Brief summary
Toric phakic IOLs are a largely reversible treatment option for patients who are not good candidates for laser refractive surgery and have significant astigmatism. Good alignment of toric IOL is crucial to achieve effective astigmatism correction. One degree of misalignment reduces the astigmatic correction by 3.3%. More than 30 degree of misalignment increasing the amount of preoperative astigmatism. Purpose of our study is to evaluate the accuracy of axis alignment , visual and refractive outcomes after toric phakic Visian toric implantable in patients with astigmatism more than 1.5D. METHODS: this retrospective study investigated toric ICL implantation in 24 eyes of 15 patients . Data were collected one week after toric ICL implantation.
Trial website
Trial related presentations / publications
Public notes

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
Fax 93890 0
Email 93890 0
Contact person for public queries
Name 93891 0
Dr 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
Fax 93891 0
Email 93891 0
Contact person for scientific queries
Name 93892 0
Dr 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
Fax 93892 0
Email 93892 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary