Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000176763
Ethics application status
Approved
Date submitted
2/02/2013
Date registered
13/02/2013
Date last updated
13/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing The Effect Of Intraocular Lenses On Optical Aberrations In Bilaterally Operated Eyes For Cataract
Scientific title
Comparing The Effect Of Intraocular Lenses On Optical Aberrations In Bilaterally Operated Eyes For Cataract
Secondary ID [1] 281883 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cataract 288276 0
Condition category
Condition code
Eye 288627 288627 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
cataract surgery

a)phacoemulsification and intraocular lens implantation

b) hydrophobic acrylic AMO Sensar AR40E and hydrophobic acrylic Alcon AcrySof SA60AT intraocular lenses
c) 15 minutes is approximite duration of the procedure
Intervention code [1] 286447 0
Treatment: Surgery
Intervention code [2] 286460 0
Treatment: Devices
Comparator / control treatment

Standard treatment will consist of treatment of cataract by surgery and intraocular hydrofobic acrylic lenses are implanted, which will take 15 minutes
Control group
Active

Outcomes
Primary outcome [1] 288778 0
There was no significant difference between group 1 and 2 in terms of optical aberration values recorded before surgery and on the month 1 and 2 after surgery (p>0.05)

On the month 1 and 2 after surgery, aberration measurements were recorded by using Nidek OPD SCAN-ARK 1000.
Timepoint [1] 288778 0
1 and 2 month after surgery
Secondary outcome [1] 300958 0
No preoperative or postoperative complication was occurred in any case. No decentralization was detected in any IOL implanted.
This complications were assessed including what methods were used to slit lamp biomicroscope
Timepoint [1] 300958 0
2 month after surgery

Eligibility
Key inclusion criteria
This study were included patients with bilateral cataract.
Minimum age
31 Years
Maximum age
82 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients previously underwent intraocular surgery, those with corneal opacity or irregularity, those with preoperative and postoperative complications, and those lost in follow-up were excluded.

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
1/12/2006
Actual
10/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4834 0
Turkey
State/province [1] 4834 0
Kayseri

Funding & Sponsors
Funding source category [1] 286668 0
University
Name [1] 286668 0
Medical Faculty of the Erciyes University
Country [1] 286668 0
Turkey
Primary sponsor type
University
Name
Medical Faculty of the Erciyes University
Address
From the Department of Ophthalmology, Medical Faculty of the Erciyes University, 38039 Kayseri
Country
Turkey
Secondary sponsor category [1] 285444 0
None
Name [1] 285444 0
Address [1] 285444 0
Country [1] 285444 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Objective: To assess the optical aberration results of hydrophobic acrylic AMO Sensar AR40E and hydrophobic acrylic Alcon AcrySof SA60AT intraocular lenses after implantation in cases with bilateral cataract.
Material and Method: Cases diagnosed as bilateral cataract were included to the study and preoperative aberration measurements were recorded by using Nidek OPD SCAN-ARK 1000. Groups were created by implanting AMO Sensar AR40E to one eye of the patients, while Alcon AcrySof SA60AT into the other in a prospective and randomized manner. On the month 1 and 2 after surgery, aberration measurements were recorded by using Nidek OPD SCAN-ARK 1000.
Findings: Overall, 40 eyes in 20 patients (11 women and 9 men) were included to the study. All patients underwent bilateral phacoemulsification surgery due to cataract. There were 20 eyes in both groups. Mean age was 62.4 (range: 31-82) years. There was no significant difference in aberrations recorded before surgery and on the month 1 and 2 after surgery between groups (p<0.05).
Conclusion: It was seen that there was no difference among spherical intraocular lenses used in this study.
Keywords: cataract, intraocular lenses, optical aberration
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37570 0
Dr Esra Ayhan Tuzcu
Address 37570 0
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University, 31034, Hatay
Country 37570 0
Turkey
Phone 37570 0
+903262291000
Fax 37570 0
Email 37570 0
[email protected]
Contact person for public queries
Name 37571 0
Dr Esra Ayhan Tuzcu
Address 37571 0
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University,31034, Hatay
Country 37571 0
Turkey
Phone 37571 0
+903262291000
Fax 37571 0
Email 37571 0
[email protected]
Contact person for scientific queries
Name 37572 0
Dr Esra Ayhan Tuzcu
Address 37572 0
From the Department of Ophthalmology, Medical Faculty of the Mustafa Kemal University,31034, Hatay
Country 37572 0
Turkey
Phone 37572 0
+903262291000
Fax 37572 0
Email 37572 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.