CataractNCT03117426
A Randomised Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLs
A study testing SYMFONY IOL and AT LISA tri 839MP IOL in people with Cataract and Presbyopia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- SYMFONY IOL and AT LISA tri 839MP IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2017to 30 Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 21 years of age
- Bilateral cataract
- Bilateral implantation of Tecnis Symfony IOL or AT LISA IOL (same lens model in both eyes)
- Expected postoperative astigmatism ≤ 1.00 D (combination with FLACS AK is tolerated up to 1.5 D preoperative astigmatism)
- IOL power calculation between +10.00 D and 32.00 D
- Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
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- Availability to undergo second eye surgery within 2 weeks of the first eye surgery
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent.
Who cannot join
- Previous corneal surgery and/or reshaping
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Irregular astigmatism
- Keratoconus
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen)
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- Extensive visual field loss (e.g., glaucoma, history of cerebral vascular accidents, etc.)
- Extensive diabetic macular disease
- History of amblyopia and/or strabismus
- Pseudoexfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- Cognitive, cerebral or concentration disorders (e.g. dementia, Parkinson, history of CVA, etc.)
- Suturing of incision required at time of surgery
- Complications during surgery of the first eye.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Official title: A Randomised, Subject-masked Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLs: the Symfony-study
Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.
The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.
Read the detailed description
Rationale: Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.
The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.
Objective: The primary objective of this study is to compare the postoperative visual outcomes in a series of patients bilaterally implanted with the AT LISA IOL versus those bilaterally implanted with the Symfony IOL.
Study design: Single-centre randomised clinical trial. Study population: 30 patients (60 eyes) with bilateral cataract who require cataract surgery.
Intervention (if applicable): Cataract surgery with bilateral implantation of either a Symfony IOL or an AT LISA IOL.
Main study parameters/endpoints: The primary endpoint is the binocular uncorrected visual acuity at 66 cm distance under both photopic and mesopic conditions 13 weeks postoperatively. Secondary endpoints are: binocular (un)corrected visual acuity at far (4 meters) and near (40 cm) under both photopic and mesopic conditions, reading performance, patient satisfaction, and complication profile.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both lens models used in this study are CE-marked and commercially available. The pre- and postoperatively examinations to be performed in this study are part of the regular medical treatment of patients with cataract who need cataract surgery. There is one more postoperative visit compared to standard cataract surgery. Potential risks, such as postoperative residual refractive error, halo's and glare, associated with multifocal IOL implantation are expected to be comparable or even lower after implantation of Symfony IOL. Spectacle-independency and high quality visual acuity postoperatively are the expected major benefits of implantation of the Symfony IOL.
- Conditions
- Cataract, Presbyopia
- Being tested
- SYMFONY IOL, AT LISA tri 839MP IOL
- Keywords
- Symfony Extended Range of Vision IOL, AT LISA tri 839MP IOL, Trifocal IOL, Extended depth of focus IOLs
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYMFONY IOLDevice
Also called EDOF IOL
IOL for presbyopic treatment in patients undergoing cataract surgery. EDOF IOL.
AT LISA tri 839MP IOLDevice
Also called Trifocal IOL
IOL for presbyopic treatment in patients undergoing cataract surgery. Trifocal IOL
| Study group | Role | What they receive |
|---|---|---|
| SYMFONY IOL | Experimental | The unique design of this IOL merges two complementary enabling technologies: (1) its diffractive echelette design feature extends the range of vision, and (2) achromatic technology corrects chromatic aberration for enhanced contrast sensitivity. Theoretically, combining these two mechanism of action results in a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs (see figure 2).
Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag. Receives: Device: SYMFONY IOL |
| AT LISA tri 839MP IOL | Active comparator | This trifocal IOL provides three useful focal distances, far, intermediate, and near, and therefore aims to provide functional visual restoration after cataract surgery.
Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag. Receives: Device: AT LISA tri 839MP IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions.
The mean binocular uncorrected intermediate visual acuity at 66 cm under both photopic and mesopic conditions at 13 weeks (3 months) postoperatively
Measured: 3 months / 13 weeks
Secondary outcomes (3)
Binocular visual acuity
At 4 meter, 40 cm, including reading speed
Measured: 3 months / 13 weeks
Quality of Life
QoL questionnaires
Measured: pre-op and 3 months/13 weeks
Contrast sensitivity
Measured: 3 months/13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Jan 2017
- Primary completion30 Sep 2017
- Study completion30 Oct 2017
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Optics
- Responsible party
- Sponsor
- Investigators
- Rudy Nuijts, MD PhD, Principal investigator, University Eye Clinic Maastricht, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117426
- Sponsor's protocol ID
- NL56878.068.16
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Subject-masked Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLs: the Symfony-study
- ClinicalTrials.gov ID
- NCT03117426
- Acronym / sponsor ID
- NL56878.068.16
- Conditions
- Cataract, Presbyopia
- Keywords
- Symfony Extended Range of Vision IOL, AT LISA tri 839MP IOL, Trifocal IOL, Extended depth of focus IOLs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Abbott Medical Optics
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 18 Apr 2017 (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.
Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.
The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.
Detailed description
Rationale: Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.
The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.
Objective: The primary objective of this study is to compare the postoperative visual outcomes in a series of patients bilaterally implanted with the AT LISA IOL versus those bilaterally implanted with the Symfony IOL.
Study design: Single-centre randomised clinical trial. Study population: 30 patients (60 eyes) with bilateral cataract who require cataract surgery.
Intervention (if applicable): Cataract surgery with bilateral implantation of either a Symfony IOL or an AT LISA IOL.
Main study parameters/endpoints: The primary endpoint is the binocular uncorrected visual acuity at 66 cm distance under both photopic and mesopic conditions 13 weeks postoperatively. Secondary endpoints are: binocular (un)corrected visual acuity at far (4 meters) and near (40 cm) under both photopic and mesopic conditions, reading performance, patient satisfaction, and complication profile.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both lens models used in this study are CE-marked and commercially available. The pre- and postoperatively examinations to be performed in this study are part of the regular medical treatment of patients with cataract who need cataract surgery. There is one more postoperative visit compared to standard cataract surgery. Potential risks, such as postoperative residual refractive error, halo's and glare, associated with multifocal IOL implantation are expected to be comparable or even lower after implantation of Symfony IOL. Spectacle-independency and high quality visual acuity postoperatively are the expected major benefits of implantation of the Symfony IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYMFONY IOL | Experimental | Device: SYMFONY IOLThe unique design of this IOL merges two complementary enabling technologies: (1) its diffractive echelette design feature extends the range of vision, and (2) achromatic technology corrects chromatic aberration for enhanced contrast sensitivity. Theoretically, combining these two mechanism of action results in a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs (see figure 2). Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag. |
| AT LISA tri 839MP IOL | Active comparator | Device: AT LISA tri 839MP IOLThis trifocal IOL provides three useful focal distances, far, intermediate, and near, and therefore aims to provide functional visual restoration after cataract surgery. Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Minimum 21 years of age
- Bilateral cataract
- Bilateral implantation of Tecnis Symfony IOL or AT LISA IOL (same lens model in both eyes)
- Expected postoperative astigmatism ≤ 1.00 D (combination with FLACS AK is tolerated up to 1.5 D preoperative astigmatism)
- IOL power calculation between +10.00 D and 32.00 D
Key exclusion criteria (14 listed)
- Previous corneal surgery and/or reshaping
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Irregular astigmatism
- Keratoconus
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
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 |
|---|---|---|
| SYMFONY IOLAlso: EDOF IOLIOL for presbyopic treatment in patients undergoing cataract surgery. EDOF IOL. | Device | SYMFONY IOL |
| AT LISA tri 839MP IOLAlso: Trifocal IOLIOL for presbyopic treatment in patients undergoing cataract surgery. Trifocal IOL | Device | AT LISA tri 839MP IOL |
Primary outcome
Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions.
Time frame: 3 months / 13 weeks
The mean binocular uncorrected intermediate visual acuity at 66 cm under both photopic and mesopic conditions at 13 weeks (3 months) postoperatively
3 secondary outcomes
Binocular visual acuity
Time frame: 3 months / 13 weeks
Quality of Life
Time frame: pre-op and 3 months/13 weeks
Contrast sensitivity
Time frame: 3 months/13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
Rudy Nuijts, MD PhD principal investigator
University Eye Clinic Maastricht, Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYMFONY IOL and AT LISA tri 839MP IOL in people with Cataract and Presbyopia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 2 May 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions. (time frame: 3 months / 13 weeks). 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 2 May 2018.