Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000913875
Ethics application status
Approved
Date submitted
23/08/2012
Date registered
28/08/2012
Date last updated
28/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of visual quality achieved with the Rayner intraocular lenses
Scientific title
Comparison of postimplantation visual quality achieved with the Rayner aspheric intraocular lenses versus spherical lenses in patients who have undergone uneventful phacoemulsification and intraocular lens implantation surgery
Secondary ID [1] 281082 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cataract 287236 0
Condition category
Condition code
Eye 287560 287560 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were implanted with an aspheric intraocular lens (IOL) Rayner 920H in one eye and a spherical IOL Rayner 620H in the fellow eye. These lenses are intraocular, so participants will be wearing the lenses for wholelife. IOL implantation is a single session going for 30 minutes. The eye implanted with the aspheric IOL was chosen at random for each patient. Rayner IOLs are single piece lenses composed of foldable hydrophilic acrylic material (refractive index, 1.46) with an overall length of 12.5 mm and optic diameter of 6.25 mm.

Recruitment period of the study is 1 year.
Intervention code [1] 285536 0
Treatment: Devices
Comparator / control treatment
Two different types of same intraocular lens (IOL) were compared. Spherical Rayner IOL group was the control group.
Control group
Active

Outcomes
Primary outcome [1] 287831 0
contrast sensitivity was assessed Hamilton-Veale contrast sensitivity test
Timepoint [1] 287831 0
at one month following surgery
Primary outcome [2] 287832 0
ocular wavefront higher order aberrations were assessed with the Schwind aberrometer
Timepoint [2] 287832 0
at one month following surgery
Secondary outcome [1] 298898 0
nil
Timepoint [1] 298898 0
nil

Eligibility
Key inclusion criteria
Patients who have undergone uneventfull phacoemulsification and IOL implantation surgery were included in the study
Minimum age
56 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included the presence of surgical complications or any ocular disease, such as corneal opacities or irregularity, amblyopia, anisometropia, glaucoma or retinal abnormalities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
3/05/2010
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] 4506 0
Turkey
State/province [1] 4506 0

Funding & Sponsors
Funding source category [1] 285867 0
Self funded/Unfunded
Name [1] 285867 0
Country [1] 285867 0
Primary sponsor type
Individual
Name
Ramazan Yagci
Address
Fatih University, Medical School
Alparslan Turkes C. No:57 06510 Emek/Ankara
Country
Turkey
Secondary sponsor category [1] 284689 0
None
Name [1] 284689 0
Address [1] 284689 0
Country [1] 284689 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 34611 0
Address 34611 0
Country 34611 0
Phone 34611 0
Fax 34611 0
Email 34611 0
Contact person for public queries
Name 17858 0
Ramazan Yagci
Address 17858 0
Fatih University, Medical School
Alparslan Turkes C. No:57 06510 Emek/Ankara
Country 17858 0
Turkey
Phone 17858 0
+903122035091
Fax 17858 0
Email 17858 0
[email protected]
Contact person for scientific queries
Name 8786 0
Ramazan Yagci
Address 8786 0
Fatih University, Medical School
Alparslan Turkes C. No:57 06510 Emek/Ankara
Country 8786 0
Turkey
Phone 8786 0
+903122035091
Fax 8786 0
Email 8786 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.