CataractNCT02155348
Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision
A study testing Bilateral cataract surgery with implantation of multifocal IOLs, Bilateral cataract surgery with monovision and Lentis LS-313 in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Bilateral cataract surgery with implantation of multifocal IOLs, Bilateral cataract surgery with monovision and Lentis LS-313
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, State of Vienna, 1140
Oliver Findl, MD, MBA, +43 1 91021 ext. 84611, oliver@findl.at
Nino Hirnschall, MD
About this study
Official title: Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision: a Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Bilateral cataract surgery with implantation of multifocal IOLs, Bilateral cataract surgery with monovision, Lentis LS-313
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral cataract surgery with implantation of multifocal IOLsProcedure or surgery
Lentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D
Bilateral cataract surgery with monovisionProcedure or surgery
Lentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D
Lentis LS-313Device
| Study group | Role | What they receive |
|---|---|---|
| Multifocal group | Active comparator | Bilateral cataract surgery with implantation of multifocal IOLs Receives: Procedure: Bilateral cataract surgery with implantation of multifocal IOLs; Device: Lentis LS-313 |
| Monovision | Active comparator | Bilateral cataract surgery with monovision Receives: Procedure: Bilateral cataract surgery with monovision; Device: Lentis LS-313 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectacle independence of patients with bilateral multifocal intraocular lenses in comparison to patients with pseudophakic monovision evaluated using a questionnaire
Measured: 3 months
Secondary outcomes (3)
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
Measured: 3 months
Reading Speed
Measured: 3 months
Stereo Vision and Contrast Sensibility
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155348
- Sponsor's protocol ID
- Lentis
- Status last verified
- Jun 2014
- First submitted
- 2 Jun 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bilateral Multifocal Intraocular Lenses and Pseudophakic Monovision: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02155348
- Acronym / sponsor ID
- Lentis
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal group | Active comparator | Procedure: Bilateral cataract surgery with implantation of multifocal IOLs, Device: Lentis LS-313Bilateral cataract surgery with implantation of multifocal IOLs |
| Monovision | Active comparator | Procedure: Bilateral cataract surgery with monovision, Device: Lentis LS-313Bilateral cataract surgery with monovision |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- Retinitis pigmentosa
- Chronic uveitis
- Amblyopia
- Pupil decentration > 1mm center shift
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral cataract surgery with implantation of multifocal IOLsLentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D | Procedure or surgery | Multifocal group |
| Bilateral cataract surgery with monovisionLentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D | Procedure or surgery | Monovision |
| Lentis LS-313 | Device | Monovision, Multifocal group |
Primary outcome
Spectacle independence of patients with bilateral multifocal intraocular lenses in comparison to patients with pseudophakic monovision evaluated using a questionnaire
Time frame: 3 months
3 secondary outcomes
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
Reading Speed
Time frame: 3 months
Stereo Vision and Contrast Sensibility
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral cataract surgery with implantation of multifocal IOLs, Bilateral cataract surgery with monovision and Lentis LS-313 in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectacle independence of patients with bilateral multifocal intraocular lenses in comparison to patients with pseudophakic monovision evaluated using a questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014; AzTrials last refreshed its copy on 1 Nov 2026.