Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Bilateral cataract surgery with implantation of multifocal IOLs
Bilateral cataract surgery with monovision
Lentis LS-313
Sponsored by

About this trial
This is an interventional treatment trial for Cataract
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 500)
- 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
- VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Multifocal group
Monovision
Arm Description
Bilateral cataract surgery with implantation of multifocal IOLs
Bilateral cataract surgery with monovision
Outcomes
Primary Outcome Measures
Spectacle independence of patients with bilateral multifocal intraocular lenses in comparison to patients with pseudophakic monovision evaluated using a questionnaire
Secondary Outcome Measures
Uncorrected and Best Corrected Distance Visual Acuity, Uncorrected and Distance Corrected Intermediate Visual Acuity, Uncorrected and Distance Corrected Near Visual Acuity between the test and the control group
Reading Speed
Stereo Vision and Contrast Sensibility
Full Information
NCT ID
NCT02155348
First Posted
June 2, 2014
Last Updated
June 3, 2014
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT02155348
Brief Title
Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision
Official Title
Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
More and more patients like to achieve complete spectacle independence after cataract surgery. Two possibilities that are particularly often used today are on the one hand multifocal lenses, and on the other hand the concept of monovision (in doing so one eye is adjusted for closeness and the other focuses for distance). The drawback with multifocal lenses is that some patients are bothered by glare phenomena, the disadvantage of monovision is that some patients lose a little of their stereo vision.
The aim of this study is a direct comparison of these two methods. Therefore 70 patients are included in 2 groups. In one group, patients receive on both sides a multifocal IOL with a near addition of +1.5 D and the patients in the second group receive monovision. One hour, 1 week and 3 months after surgery, patients are invited and tests for visual accuity are performed for near vision (40cm), intermediate vision (80cm) and distant vision (400cm). Furthermore, contrast sensitivity and stereopsis of patients is assesed. Additional measurements for detecting the tilt of the lens will be performed.
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 current technique available to surgeons to reduce spectacle dependence is to use bilateral multifocal IOLs. However, a variable number of patients do complain of problems with glare, haloes and lights especially in the hours of darkness (dysphotopsia symptoms). Dysphotopsia symptoms may vary significantly from patient to patient. The real incidence of dysphotopsia like symptoms after cataract surgery and multifocal IOL is unknown 6 and the implantation of multifocal IOLs is a commonly accepted contraindication in patients who are night drivers.
Another option to allow spectacle independence is monovision. Monovision is where one eye can see clearly in the distance and the other eye is intentionally made short-sighted so that it has either near reading vision (full monovision) or intermediate (arms length) or distance vision (limited monovision). Monovision has two major advantages, very little dysphotopsia and it is cheaper compared to multifocal IOLs. However, disadvantages are a reduced stereopsis and there is a need for neuroadaptation.
The rationale of this trial was to compare bilateral multifocal intraocular lenses (MIOLs) with monovision after cataract surgery concerning visual function and spectacle independence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multifocal group
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with implantation of multifocal IOLs
Arm Title
Monovision
Arm Type
Active Comparator
Arm Description
Bilateral cataract surgery with monovision
Intervention Type
Procedure
Intervention Name(s)
Bilateral cataract surgery with implantation of multifocal IOLs
Intervention Description
Lentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D
Intervention Type
Procedure
Intervention Name(s)
Bilateral cataract surgery with monovision
Intervention Description
Lentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D
Intervention Type
Device
Intervention Name(s)
Lentis LS-313
Primary Outcome Measure Information:
Title
Spectacle independence of patients with bilateral multifocal intraocular lenses in comparison to patients with pseudophakic monovision evaluated using a questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Uncorrected and Best Corrected Distance Visual Acuity, Uncorrected and Distance Corrected Intermediate Visual Acuity, Uncorrected and Distance Corrected Near Visual Acuity between the test and the control group
Time Frame
3 months
Title
Reading Speed
Time Frame
3 months
Title
Stereo Vision and Contrast Sensibility
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 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 500)
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
Facility Information:
Facility Name
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, MBA
Phone
+43 1 91021
Ext
84611
Email
oliver@findl.at
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
First Name & Middle Initial & Last Name & Degree
Sophie Maedel, MD
First Name & Middle Initial & Last Name & Degree
Maria Weber, MD
First Name & Middle Initial & Last Name & Degree
Jörg Wiesinger, MD
First Name & Middle Initial & Last Name & Degree
Petra Draschl, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision
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