CataractNCT03748381
Comparison of 2 Diffractive Trifocal IOLs
A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2018to 1 Apr 2020
- 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 to 105 years
- 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 700)
- 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
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Martin Kronschläger, MD, 01 91021-57572, office@viros.at
Julius Hienert, MD, 01 91021-57564, office@viros.at
About this study
Official title: Comparison of Visual Performance of 2 Diffractive Trifocal Intraocular Lenses: a Randomised Controlled Trial
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.
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 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.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Cataract surgery, Trifocal IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
During cataract surgery patients will be implanted with the AT Zeiss Lisa tri in one eye and the Rayner trifocal in the contralateral eye
| Study group | Role | What they receive |
|---|---|---|
| Trifocal IOL | Experimental | The patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Near Visual Acuity
Uncorrected Near Visual Acuity will be assessed with ETDRS charts
Measured: 12 months
Secondary outcomes (5)
Uncorrected and Best corrected Far and Intermediate Visual Acuity,
Uncorrected and Best corrected Far and Intermediate Visual Acuity will be assessed with ETDRS charts
Measured: 12 months
Halo measurements
Halos will be assessed using the Halometer App on a tablet
Measured: 12 months
Reading speed
Reading speed will be assessed using the Salzburg Reading Desk
Measured: 12 months
Defocus curve
A defocus curve will be done by adding glasses starting from -4.0D to +2.0D to the best corrected far correction
Measured: 12 months
Contrast sensitivity
Contrast sensitivity will be assessed using the Optec Vision tester
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748381
- Sponsor's protocol ID
- Trifocal
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Performance of 2 Diffractive Trifocal Intraocular Lenses: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03748381
- Acronym / sponsor ID
- Trifocal
- Conditions
- Cataract
- Keywords
- Cataract surgery, Trifocal IOL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 20 Nov 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifocal IOL | Experimental | Procedure: Cataract surgeryThe patients will receive two different diffractive trifocal IOLs in each eye (AT Lisa tri vs. Rayner trifocal) during cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- 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 700)
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 |
|---|---|---|
| Cataract surgeryDuring cataract surgery patients will be implanted with the AT Zeiss Lisa tri in one eye and the Rayner trifocal in the contralateral eye | Procedure or surgery | Trifocal IOL |
Primary outcome
Uncorrected Near Visual Acuity
Time frame: 12 months
Uncorrected Near Visual Acuity will be assessed with ETDRS charts
5 secondary outcomes
Uncorrected and Best corrected Far and Intermediate Visual Acuity,
Time frame: 12 months
Halo measurements
Time frame: 12 months
Reading speed
Time frame: 12 months
Defocus curve
Time frame: 12 months
Contrast sensitivity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA 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 23 Nov 2018. 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?
Contact Martin Kronschläger, MD (01 910 21-57572, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Near Visual Acuity (time frame: 12 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 23 Nov 2018.