Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000909224
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
30/05/2018
Date last updated
30/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Visual and Refractive Outcomes Of posterior chamber phakic IOL In stable keratoconus
Scientific title
Visual and Refractive Outcomes Of posterior chamber phakic IOL In stable keratoconus
Secondary ID [1] 294993 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
keratoconus 308008 0
Condition category
Condition code
Eye 307047 307047 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
phakic posterior lens implantation to correct refractive error in cases of stable keratoconus
done by surgeons who have at least 20 years of experience.In this study,

the current V4C ICL design was used. Under local anesthesia, dilating agents were administered. For the toric ICL implantation, the axis was marked using Neuhann-Nuijts One-Step Toric Marker (ASICO) while the patient was lying upright to prevent cyclotorsion. 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 and the TICL was aligned to the desired axis.
Intervention code [1] 301333 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306021 0
visual acuity before and after lens implantation using LogMAR chart
Timepoint [1] 306021 0
6 months post surgery
Primary outcome [2] 306055 0
quality of vision using OPD scan II
Timepoint [2] 306055 0
6 months post surgery
Secondary outcome [1] 347364 0
any residual spherical and/or cylindrical error after surgery
and comparing between target and achieved
with subjective refraction
Timepoint [1] 347364 0
6 months post surgery

Eligibility
Key inclusion criteria
patients age 21 to 45 years old
stable keratoconus
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
very irregular cornea by topography
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/06/2015
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
30/11/2017
Sample size
Target
20
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 10506 0
United Arab Emirates
State/province [1] 10506 0
Dubai

Funding & Sponsors
Funding source category [1] 299578 0
Hospital
Name [1] 299578 0
Magrabi eye hospital
Country [1] 299578 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] 298892 0
Individual
Name [1] 298892 0
Sherif Emerah
Address [1] 298892 0
Dubai health care city
Magrabi eye hospital
ALRAzi building #64 Block E 2nd floor
Dubai-UAE
Country [1] 298892 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300480 0
Magrabi eye hospital ethics committee
Ethics committee address [1] 300480 0
Ethics committee country [1] 300480 0
United Arab Emirates
Date submitted for ethics approval [1] 300480 0
04/04/2016
Approval date [1] 300480 0
04/05/2016
Ethics approval number [1] 300480 0

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

Contacts
Principal investigator
Name 83790 0
Dr Sherif Emerah
Address 83790 0
Dubai health care city
ALRazi building #64
Block E
2nd floor
Magrabi eye hospital
Country 83790 0
United Arab Emirates
Phone 83790 0
+971566538724
Fax 83790 0
Email 83790 0
[email protected]
Contact person for public queries
Name 83791 0
Sherif Emerah
Address 83791 0
Dubai health care city
ALRazi building #64
Block E
2nd floor
Magrabi eye hospital
Country 83791 0
United Arab Emirates
Phone 83791 0
+971566538724
Fax 83791 0
Email 83791 0
[email protected]
Contact person for scientific queries
Name 83792 0
Sherif Emerah
Address 83792 0
Dubai health care city
ALRazi building #64
Block E
2nd floor
Magrabi eye hospital
Country 83792 0
United Arab Emirates
Phone 83792 0
+971566538724
Fax 83792 0
Email 83792 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.