Lenses, IntraocularNCT03505827
Visual Field Changes in TECNIS ZCB00 Monofocal vs. TECNIS Symfony Extended Depth of Focus Intraocular Lens Implantation
An observational study of Lenses, Intraocular and Visual Fields, run by Western University, Canada at 2 sites in Canada.
Trial summary
Glaucoma is a leading cause of blindness worldwide. Damage to the optic nerve results in vision loss gradually. This vision loss can be detected by using visual field testing, and is a way of monitoring glaucoma progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lenses, Intraocular, Visual Fields, Cataract
- What is being tested?
- 24-2 SITA Standard Humphrey Visual Field Test
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2018to 1 Oct 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patients undergoing cataract surgery at the Ivey Eye Clinic in London, Ontario, Canda who chose to receive a TECNIS Symfony intraocular lens implant or TECNIS monofocal ZCB00 intraocular lens implant will be approached to be enrolled in the study AFTER determining their decision to undergo cataract surgery and decision of lens implantation has been made.
Who may be able to join
- Patients who have chosen to undergo elective cataract surgery in one eye with 20/40 - 20/100 vision (best corrected) in the operated eye on initial pre-op surgical assessment and with greater than or equal to 20/25 vision (best corrected) in the operated eye at 1-month post-operatively.
- Patients who have chosen to undergo TECNIS ZCB00 monofocal intraocular lens implantation.
- Patients who have chosen to undergo implantation of a TECNIS Symfony extended depth of focus intraocular lens.
- Patient must be able to reliably perform visual field testing.
- No other eye disease other than cataract.
- Patient must be older than 18 years of age.
- Patient must be proficient in the English language.
Who cannot join
- Patients who are unwilling or unable to undergo visual field testing.
- Patients with glaucoma.
- Patients who have history of laser refractive surgery.
- Patients who experienced an intra-operative complication.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ivey Eye Institute
London, Ontario, N6A 4V2
St. Joseph's Health Care London
London, Ontario, N6A 4V2
About this study
Official title: Visual Field Changes in Patients Undergoing TECNIS ZCB00 Monofocal vs. TECNIS Symfony Extended Depth of Focus Intraocular Lens Implantation
Glaucoma is a leading cause of blindness worldwide. Damage to the optic nerve results in vision loss gradually. This vision loss can be detected by using visual field testing, and is a way of monitoring glaucoma progression. As this population ages, cataracts develop, and patients need to undergo cataract surgery to replace the cloudy crystalline lens with an artificial intraocular lens (IOL). The standard of treatment is implantation of a monofocal IOL, but this limits depth of focus and does not allow clear vision at both distance and near without glasses post-operatively. Multifocal and trifocal lenses split light into multiple distinct foci at near, intermediate and far distances without glasses correction. However, these lenses have been shown to reduce contrast sensitivity and impair visual field testing results, and are not recommended in patients with glaucoma. The TECNIS Symfony IOL has recently been approved by Health Canada and offers an extended range of vision with a single elongated focal point to allow patients to see at both distance and near. The lens is advertised to enhance contrast sensitivity, but it is currently unknown whether the TECNIS Symfony IOL impacts visual field testing. We will study the visual field changes in patients undergoing both TECNIS ZCB00 monofocal and TECNIS Symfony extended depth of focus IOL implantation during cataract surgery. The results of this study will impact the advice cataract surgeons give to patients with glaucoma, regarding whether this population of patients would benefit from a standard monofocal IOL implantation or an extended depth of focus TECNIS Symfony IOL implantation.
Read the detailed description
Primary open angle glaucoma is a leading cause of blindness worldwide, and is the most common form of glaucoma. This condition involves progressive damage to the optic nerve over time and ultimately vision loss that can be detected using standard automated perimetry visual field testing. As this population ages, patients will eventually develop cataracts and require cataract surgery to replace the cloudy crystalline lens with an artificial intraocular lens. The standard of treatment is implantation of a monofocal intraocular lens (IOL), but this limits depth of focus and does not allow clear vision at both distance and near without spectacle correction post-operatively. To provide a refractive component to cataract surgery, multifocal and trifocal lenses were introduced and split light into multiple distinct foci at near, intermediate and far distances without correction. However, splitting of incoming light has the potential to decrease contrast sensitivity and increase photic phenomena. In addition, multifocal IOLs have been shown to reduce mean deviation on automated perimetry compared to monofocal IOLs and are not recommended in patients where visual field reduction may not be tolerated, such as in patients with glaucoma. The TECNIS Symfony IOL has been recently been approved by Health Canada and offers extended range of vision with a single elongated focal point, corrects for chromatic aberration and results in contrast enhancement. It is unknown whether this new IOL impacts visual field testing in glaucoma patients post cataract surgery.
The objective of this study is to compare visual field outcomes in patients choosing to undergo cataract surgery with either a TECNIS ZCB00 monofocal vs TECNIS Symfony extended depth of focus intraocular lens.
It is hypothesized that patients who undergo implantation of a TECNIS Symfony extended depth of focus intraocular lens will have impaired visual field testing (a decrease in mean deviation on Humphrey 24-2 standard automated perimetry) compared to those undergoing TECNIS ZCB00 monofocal intraocular lens implantation.
This will be a prospective cohort study.
Patients undergoing either TECNIS ZCB00 monofocal or TECNIS Symfony extended depth of focus ZXR intraocular lens insertion during cataract surgery will be recruited.
Patients will not be approached regarding the study until the patient decides which lens will be inserted during surgery. This study has no impact on a patient's choice of intraocular lens. This study will not be assigning a lens as part of the intervention.
There will be no randomization of the groups, given that patients will be choosing which lens will be implanted during surgery pre-operatively, as any other patient undergoing cataract surgery would.
There will be no blinding of study participants or of the investigators.
As per standard pre-operative assessment, patients will have ocular Biometry performed prior to surgery to assess what prism diopter lens to insert intra-operatively.
On the day of this appointment, participants will be asked to perform a 24-2 Humphrey standard automated perimetry visual field test with Swedish Interactive Threshold Algorithm (SITA) standard thresholds.
In addition, at the 1-month post-operative appointment, participants will be asked to again complete a 24-2 Humphrey visual field, in addition to the standard post-operative examination.
- Conditions
- Lenses, Intraocular, Visual Fields, Cataract
- Being tested
- 24-2 SITA Standard Humphrey Visual Field Test
- Keywords
- TECNIS Symfony
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-2 SITA Standard Humphrey Visual Field TestDiagnostic test
Patients participate in a 24-2 SITA Standard humphrey visual field test. This includes sitting in a dark room at a visual field machine. Stimulus test points of different intensity and size will be presented to the patient, as per SITA standard protocol. The patient will indicate by pressing a button when they see the visual stimulus.
| Study group | Role | What they receive |
|---|---|---|
| TECNIS Monofocal | This group of patients has chosen to undergo implantation of a TECNIS monofocal ZCB00 lens during cataract surgery. This decision was made prior to enrolment in the study. This group of patients will receive standard of care cataract surgery, as any other patient would. The sole intervention we will be undertaking is a 24-2 Humphrey visual field test prior to surgery, and a 24-2 SITA standard Humphrey visual field test after surgery at 1 month post-operatively. Receives: Diagnostic Test: 24-2 SITA Standard Humphrey Visual Field Test | |
| TECNIS Symfony | This group of patients has chosen to undergo implantation of a TECNIS Symfony extended depth of focus lens during cataract surgery. This decision was made prior to enrolment in the study. This group of patients will receive standard of care cataract surgery, as any other patient would. The sole intervention we will be undertaking is a 24-2 SITA standard Humphrey visual field test prior to surgery, and a 24-2 Humphrey visual field test after surgery at 1 month post-operatively. Receives: Diagnostic Test: 24-2 SITA Standard Humphrey Visual Field Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Deviation
An overall value of the total amount of visual field loss
Measured: 1 year
Secondary outcomes (1)
Pattern Standard Deviation
The sum of the absolute value of the difference between the threshold value for each point and the average visual field sensitivity at each point.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Jun 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: No participants were successfully enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lenses, IntraocularStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Ivey Eye Institute
- Responsible party
- Principal investigator, Tony Lin, Western University, Canada
- Investigators
- Tony Lin, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505827
- Sponsor's protocol ID
- 111201
- Status last verified
- Oct 2019
- First submitted
- 12 Apr 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Farid M, Chak G, Garg S, Steinert RF. Reduction in mean deviation values in automated perimetry in eyes with multifocal compared to monofocal intraocular lens implants. Am J Ophthalmol. 2014 Aug;158(2):227-231.e1. doi: 10.1016/j.ajo.2014.04.017. Epub 2014 Apr 29.
PubMed 24784872de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
PubMed 29138533Shen Z, Lin Y, Zhu Y, Liu X, Yan J, Yao K. Clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses: a systematic review and meta-analysis. Sci Rep. 2017 Mar 28;7:45337. doi: 10.1038/srep45337.
PubMed 28422087Nouri-Mahdavi K. Selecting visual field tests and assessing visual field deterioration in glaucoma. Can J Ophthalmol. 2014 Dec;49(6):497-505. doi: 10.1016/j.jcjo.2014.10.002.
PubMed 25433738Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
PubMed 24974815
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Field Changes in Patients Undergoing TECNIS ZCB00 Monofocal vs. TECNIS Symfony Extended Depth of Focus Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT03505827
- Acronym / sponsor ID
- 111201
- Conditions
- Lenses, Intraocular, Visual Fields, Cataract
- Keywords
- TECNIS Symfony
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were successfully enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Ivey Eye Institute
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 23 Apr 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.
Glaucoma is a leading cause of blindness worldwide. Damage to the optic nerve results in vision loss gradually. This vision loss can be detected by using visual field testing, and is a way of monitoring glaucoma progression. As this population ages, cataracts develop, and patients need to undergo cataract surgery to replace the cloudy crystalline lens with an artificial intraocular lens (IOL). The standard of treatment is implantation of a monofocal IOL, but this limits depth of focus and does not allow clear vision at both distance and near without glasses post-operatively. Multifocal and trifocal lenses split light into multiple distinct foci at near, intermediate and far distances without glasses correction. However, these lenses have been shown to reduce contrast sensitivity and impair visual field testing results, and are not recommended in patients with glaucoma. The TECNIS Symfony IOL has recently been approved by Health Canada and offers an extended range of vision with a single elongated focal point to allow patients to see at both distance and near. The lens is advertised to enhance contrast sensitivity, but it is currently unknown whether the TECNIS Symfony IOL impacts visual field testing. We will study the visual field changes in patients undergoing both TECNIS ZCB00 monofocal and TECNIS Symfony extended depth of focus IOL implantation during cataract surgery. The results of this study will impact the advice cataract surgeons give to patients with glaucoma, regarding whether this population of patients would benefit from a standard monofocal IOL implantation or an extended depth of focus TECNIS Symfony IOL implantation.
Detailed description
Primary open angle glaucoma is a leading cause of blindness worldwide, and is the most common form of glaucoma. This condition involves progressive damage to the optic nerve over time and ultimately vision loss that can be detected using standard automated perimetry visual field testing. As this population ages, patients will eventually develop cataracts and require cataract surgery to replace the cloudy crystalline lens with an artificial intraocular lens. The standard of treatment is implantation of a monofocal intraocular lens (IOL), but this limits depth of focus and does not allow clear vision at both distance and near without spectacle correction post-operatively. To provide a refractive component to cataract surgery, multifocal and trifocal lenses were introduced and split light into multiple distinct foci at near, intermediate and far distances without correction. However, splitting of incoming light has the potential to decrease contrast sensitivity and increase photic phenomena. In addition, multifocal IOLs have been shown to reduce mean deviation on automated perimetry compared to monofocal IOLs and are not recommended in patients where visual field reduction may not be tolerated, such as in patients with glaucoma. The TECNIS Symfony IOL has been recently been approved by Health Canada and offers extended range of vision with a single elongated focal point, corrects for chromatic aberration and results in contrast enhancement. It is unknown whether this new IOL impacts visual field testing in glaucoma patients post cataract surgery.
The objective of this study is to compare visual field outcomes in patients choosing to undergo cataract surgery with either a TECNIS ZCB00 monofocal vs TECNIS Symfony extended depth of focus intraocular lens.
It is hypothesized that patients who undergo implantation of a TECNIS Symfony extended depth of focus intraocular lens will have impaired visual field testing (a decrease in mean deviation on Humphrey 24-2 standard automated perimetry) compared to those undergoing TECNIS ZCB00 monofocal intraocular lens implantation.
This will be a prospective cohort study.
Patients undergoing either TECNIS ZCB00 monofocal or TECNIS Symfony extended depth of focus ZXR intraocular lens insertion during cataract surgery will be recruited.
Patients will not be approached regarding the study until the patient decides which lens will be inserted during surgery. This study has no impact on a patient's choice of intraocular lens. This study will not be assigning a lens as part of the intervention.
There will be no randomization of the groups, given that patients will be choosing which lens will be implanted during surgery pre-operatively, as any other patient undergoing cataract surgery would.
There will be no blinding of study participants or of the investigators.
As per standard pre-operative assessment, patients will have ocular Biometry performed prior to surgery to assess what prism diopter lens to insert intra-operatively.
On the day of this appointment, participants will be asked to perform a 24-2 Humphrey standard automated perimetry visual field test with Swedish Interactive Threshold Algorithm (SITA) standard thresholds.
In addition, at the 1-month post-operative appointment, participants will be asked to again complete a 24-2 Humphrey visual field, in addition to the standard post-operative examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECNIS Monofocal | – | Diagnostic Test: 24-2 SITA Standard Humphrey Visual Field TestThis group of patients has chosen to undergo implantation of a TECNIS monofocal ZCB00 lens during cataract surgery. This decision was made prior to enrolment in the study. This group of patients will receive standard of care cataract surgery, as any other patient would. The sole intervention we will be undertaking is a 24-2 Humphrey visual field test prior to surgery, and a 24-2 SITA standard Humphrey visual field test after surgery at 1 month post-operatively. |
| TECNIS Symfony | – | Diagnostic Test: 24-2 SITA Standard Humphrey Visual Field TestThis group of patients has chosen to undergo implantation of a TECNIS Symfony extended depth of focus lens during cataract surgery. This decision was made prior to enrolment in the study. This group of patients will receive standard of care cataract surgery, as any other patient would. The sole intervention we will be undertaking is a 24-2 SITA standard Humphrey visual field test prior to surgery, and a 24-2 Humphrey visual field test after surgery at 1 month post-operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patients undergoing cataract surgery at the Ivey Eye Clinic in London, Ontario, Canda who chose to receive a TECNIS Symfony intraocular lens implant or TECNIS monofocal ZCB00 intraocular lens implant will be approached to be enrolled in the study AFTER determining their decision to undergo cataract surgery and decision of lens implantation has been made.
Key inclusion criteria (7 listed)
- Patients who have chosen to undergo elective cataract surgery in one eye with 20/40 - 20/100 vision (best corrected) in the operated eye on initial pre-op surgical assessment and with greater than or equal to 20/25 vision (best corrected) in the operated eye at 1-month post-operatively.
- Patients who have chosen to undergo TECNIS ZCB00 monofocal intraocular lens implantation.
- Patients who have chosen to undergo implantation of a TECNIS Symfony extended depth of focus intraocular lens.
- Patient must be able to reliably perform visual field testing.
- No other eye disease other than cataract.
Key exclusion criteria (4 listed)
- Patients who are unwilling or unable to undergo visual field testing.
- Patients with glaucoma.
- Patients who have history of laser refractive surgery.
- Patients who experienced an intra-operative complication.
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 |
|---|---|---|
| 24-2 SITA Standard Humphrey Visual Field TestPatients participate in a 24-2 SITA Standard humphrey visual field test. This includes sitting in a dark room at a visual field machine. Stimulus test points of different intensity and size will be presented to the patient, as per SITA standard protocol. The patient will indicate by pressing a button when they see the visual stimulus. | Diagnostic test | TECNIS Monofocal, TECNIS Symfony |
Primary outcome
Mean Deviation
Time frame: 1 year
An overall value of the total amount of visual field loss
1 secondary outcome
Pattern Standard Deviation
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 24784872Farid M, Chak G, Garg S, Steinert RF. Reduction in mean deviation values in automated perimetry in eyes with multifocal compared to monofocal intraocular lens implants. Am J Ophthalmol. 2014 Aug;158(2):227-231.e1. doi: 10.1016/j.ajo.2014.04.017. Epub 2014 Apr 29.
- Background: PubMed 29138533de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
- Background: PubMed 28422087Shen Z, Lin Y, Zhu Y, Liu X, Yan J, Yao K. Clinical comparison of patient outcomes following implantation of trifocal or bifocal intraocular lenses: a systematic review and meta-analysis. Sci Rep. 2017 Mar 28;7:45337. doi: 10.1038/srep45337.
- Background: PubMed 25433738Nouri-Mahdavi K. Selecting visual field tests and assessing visual field deterioration in glaucoma. Can J Ophthalmol. 2014 Dec;49(6):497-505. doi: 10.1016/j.jcjo.2014.10.002.
- Background: PubMed 24974815Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
- Individual participant dataSharing planned: No
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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.
Tony Lin, MD principal investigator
Western University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lenses, Intraocular and Visual Fields, run by Western University, Canada at 2 sites in Canada.
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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean Deviation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505827, which also lists 5 linked publications.
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 Oct 2019.