Comparison of 2 Diffractive Trifocal IOLs
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract surgery, Trifocal IOL
Eligibility Criteria
Inclusion Criteria:
- Age-related cataract
- Scheduled for bilateral cataract extraction
- Motivated to be less spectacle dependant
- Age 21 and older
- Corneal astigmatism ≤ 1.5 D (Keratometry, IOL Master 700)
- written informed consent prior to recruitment
Exclusion Criteria:
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- Retinitis pigmentosa
- Chronic uveitis
- Amblyopia
- Pupil decentration > 1mm center shift
- preceded retinal surgery
- preceded Laser-in-situ-Keratomileusis (LASIK)
- Any ophthalmic abnormality that could compromise visual function or the measurements
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trifocal IOL
Arm Description
The patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery
Outcomes
Primary Outcome Measures
Uncorrected Near Visual Acuity
Uncorrected Near Visual Acuity will be assessed with ETDRS charts
Secondary Outcome Measures
Uncorrected and Best corrected Far and Intermediate Visual Acuity,
Uncorrected and Best corrected Far and Intermediate Visual Acuity will be assessed with ETDRS charts
Halo measurements
Halos will be assessed using the Halometer App on a tablet
Reading speed
Reading speed will be assessed using the Salzburg Reading Desk
Defocus curve
A defocus curve will be done by adding glasses starting from -4.0D to +2.0D to the best corrected far correction
Contrast sensitivity
Contrast sensitivity will be assessed using the Optec Vision tester
Full Information
NCT ID
NCT03748381
First Posted
November 19, 2018
Last Updated
November 20, 2018
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03748381
Brief Title
Comparison of 2 Diffractive Trifocal IOLs
Official Title
Comparison of Visual Performance of 2 Diffractive Trifocal Intraocular Lenses: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Compare two commercially available bilateral implanted diffractive trifocal lenses (Zeiss AT Lisa tri vs. Rayner trifocal) after cataract surgery concerning visual function and spectacle independence.
Detailed Description
Spectacle independence is a central aim in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satisfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result.
The option commonly used to achieve spectacle independence are multifocal intraocular lenses (IOLs). Multifocal IOLs either use a refractive or diffractive design or a combination of both or segmented asymmetric optics. The principal of the refractive design is based on changing the route of light rays by thickness, curvature and optical density of the lens. The principal of diffractive design is based on scattering of light rays when passing an edge in the material of the lens. One potentially negative aspect of multifocal refractive IOLs is pupil size dependence, another is loss of light energy to higher order diffraction which is not useful to the patient. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and lens photopic phenomena (dysphotopsia such as halos and glare) than in refractive lenses.
Until recently multifocal lenses were typically bifocal with a focus assigned to near and a focus assigned to far vision. However, the intermediate working distance is poorly covered by that multifocal design. Since objects commonly viewed in this distance include computer displays and tablets, the intermediate distance has become a crucial part in daily life. As a consequence of poor intermediate visual acuity there is a need for spectacles for intermediate vision. Variations in the addition of power chosen for near vision provided some intermediate visual acuity but still suboptimal.
Therefore, a new concept of multifocality has been recently introduced, i.e. the trifocal lens. Trifocal lenses provide three focal distances, far, intermediate and near. This ideally results in even less spectacle dependence, including computer work. There are currently 3 trifocal designs available and are being used readily. One potential disadvantage of trifocal compared to bifocal IOLs is that near vision may be slightly poorer with the need for reading glasses with prolonged fine near work.
A slightly modified trifocal design has been recently introduced, that appears to have even better near vision than other trifocal designs as well as the potential for less dysphotopsia with a dilated pupil such as during the night.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract surgery, Trifocal IOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trifocal IOL
Arm Type
Experimental
Arm Description
The patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
During cataract surgery patients will be implanted with the AT Zeiss Lisa tri in one eye and the Rayner trifocal in the contralateral eye
Primary Outcome Measure Information:
Title
Uncorrected Near Visual Acuity
Description
Uncorrected Near Visual Acuity will be assessed with ETDRS charts
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Uncorrected and Best corrected Far and Intermediate Visual Acuity,
Description
Uncorrected and Best corrected Far and Intermediate Visual Acuity will be assessed with ETDRS charts
Time Frame
12 months
Title
Halo measurements
Description
Halos will be assessed using the Halometer App on a tablet
Time Frame
12 months
Title
Reading speed
Description
Reading speed will be assessed using the Salzburg Reading Desk
Time Frame
12 months
Title
Defocus curve
Description
A defocus curve will be done by adding glasses starting from -4.0D to +2.0D to the best corrected far correction
Time Frame
12 months
Title
Contrast sensitivity
Description
Contrast sensitivity will be assessed using the Optec Vision tester
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age-related cataract
Scheduled for bilateral cataract extraction
Motivated to be less spectacle dependant
Age 21 and older
Corneal astigmatism ≤ 1.5 D (Keratometry, IOL Master 700)
written informed consent prior to recruitment
Exclusion Criteria:
Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
Retinitis pigmentosa
Chronic uveitis
Amblyopia
Pupil decentration > 1mm center shift
preceded retinal surgery
preceded Laser-in-situ-Keratomileusis (LASIK)
Any ophthalmic abnormality that could compromise visual function or the measurements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Kronschläger, MD
Phone
01 910 21-57572
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Julius Hienert, MD
Phone
01 910 21-57562
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kronschläger, MD
Phone
01 91021-57572
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Julius Hienert, MD
Phone
01 91021-57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of 2 Diffractive Trifocal IOLs
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