Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000663055
Ethics application status
Approved
Date submitted
1/07/2010
Date registered
16/08/2010
Date last updated
16/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Accommodation Capabilities of Three Different Intraocular Lenses
Scientific title
A Comparison of Accommodation Amplitudes of Three Different Acrylic Intraocular Lenses in patients who have undergone uneventful phacoemulsification and intraocular lens implantation surgery
Secondary ID [1] 252143 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cataract 257683 0
Condition category
Condition code
Eye 257858 257858 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We compared three different types of intraocular lenses (IOL), AcrySof MA60BM, Sensar AR40e, and the Rayner C-Flex 2. These lenses are intraocular, so participants will be wearing the lenses for wholelife. There are three different groups of participants who wear one type of lens only. The AcrySof MA60BM (Alcon Inc, Fort Worth, TX, USA) is a 3-piece hydrophobic acrylic IOL with flexible polymethyl methacrylate (PMMA) C-loop haptics with 10-degree angulation. Its overall length is 13.0 mm, with a biconvex optic having a diameter of 6.0 mm. The Sensar AR40e (Abbott Medical Optics, Santa Ana, CA, USA) is a 3-piece hydrophobic acrylic IOL with flexible PMMA C-loop haptics with 5-degree angulation. Its overall length is 13.0 mm, with a biconvex optic having a diameter of 6.0 mm. The Rayner C-Flex (Rayner Intraocular Lenses Limited, East Sussex, UK) is a 1-piece hydrophilic acrylic IOL. This lens has a plate-haptic configuration without angulation. It has a body diameter of 5.75 mm and overall length of 12.00 mm.

Overall duration of this observational study is 6 months
Intervention code [1] 256744 0
Not applicable
Comparator / control treatment
Three different types of intraocular lenses were compared
Control group
Active

Outcomes
Primary outcome [1] 258720 0
To assess the accommodative amplitudes of three different foldable acrylic intraocular lenses (IOLs) by measuring with photorefractor Plusoptix CR03
Timepoint [1] 258720 0
at one month following surgery
Secondary outcome [1] 264760 0
nil
Timepoint [1] 264760 0
nil

Eligibility
Key inclusion criteria
Patients who have undergone uneventfull phacoemulsification and IOL implantation surgery were included in the study. Accomodation measurements were taken 1 month after the surgery
Minimum age
40 Years
Maximum age
83 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
clinically significant IOL decentration, more than 1.0 D of corneal astigmatism, postoperative inflammation causing posterior or anterior synechia formation or any eye pathology affecting complete visual acuity

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment outside Australia
Country [1] 2741 0
Turkey
State/province [1] 2741 0

Funding & Sponsors
Funding source category [1] 257238 0
Self funded/Unfunded
Name [1] 257238 0
Country [1] 257238 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] 256483 0
None
Name [1] 256483 0
Address [1] 256483 0
Country [1] 256483 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Accommodation is ability of the eye to adjust to an object at any given distance, projecting this object onto the retina where it creates a focused image. So, we can see near objects through accommodation ability. Patients who have undergone phacoemulsification and IOL implantation surgery (pseudophakic) loss the accommodation ability and need correction with glasses. But, some pseudophakic patients with monofocal IOLs have good near visual acuity without correction.

Our hypothesis is monofocal IOLs either monoblock or three piece may have some degree of accommodative amplitudes in vivo. Our purpose is to assess the accommodative amplitudes of three different foldable acrylic IOLs by measuring with photorefractor Plusoptix CR03 (Plusoptix GmbH, Nuernberg, Germany). The second aim of the study is to compare the accomodative amplitudes of the monoblock or three piece foldable acrylic IOLs if any
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31358 0
Address 31358 0
Country 31358 0
Phone 31358 0
Fax 31358 0
Email 31358 0
Contact person for public queries
Name 14605 0
Ramazan Yagci
Address 14605 0
Fatih University, Medical School
Alparslan Turkes C. No:57 06510 Emek/Ankara
Country 14605 0
Turkey
Phone 14605 0
+903122035091
Fax 14605 0
Email 14605 0
[email protected]
Contact person for scientific queries
Name 5533 0
Ramazan Yagci
Address 5533 0
Fatih University, Medical School
Alparslan Turkes C. No:57 06510 Emek/Ankara
Country 5533 0
Turkey
Phone 5533 0
+903122035091
Fax 5533 0
Email 5533 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
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