Cataract BilateralNCT03082599
Symfony Toric Intraocular Lens Visual Outcomes
A study testing Presbyopia and astigmatism correcting intraocular lens in people with Cataract Bilateral and Astigmatism Bilateral, run by Carolina Eyecare Physicians, LLC at 4 sites in United States.
Trial summary
In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Cataract Bilateral, Astigmatism Bilateral
- What is being tested?
- Presbyopia and astigmatism correcting intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Feb 2017to 3 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
- Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
- Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Who cannot join
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy
Show all 18Show fewer
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous intraocular surgery.
- Previous refractive surgery.
- Previous keratoplasty
- Severe dry eye
- Pupil abnormalities
- Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK)
- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ophthalmic Consultants of Long Island
Garden City, New York, 11530
Slade & Baker Vision Center
Houston, Texas, 77027
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Associated Eye Care
Stillwater, Minnesota, 55082
About this study
Official title: Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
- Conditions
- Cataract Bilateral, Astigmatism Bilateral
- Being tested
- Presbyopia and astigmatism correcting intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presbyopia and astigmatism correcting intraocular lensDevice
The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Emmetropia both eyes (OU) group | Active comparator | Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). Receives: Device: Presbyopia and astigmatism correcting intraocular lens |
| Nanovision group | Experimental | Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. Receives: Device: Presbyopia and astigmatism correcting intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Distance-corrected Near (40 cm) Visual Acuity.
Visual acuity with correction (glasses) measured at 40 cm.
Measured: 3 months
Reduction of Manifest Cylinder (Diopters).
Measured: 3 months
Secondary outcomes (5)
Uncorrected Near (40 cm) Visual Acuity
Visual acuity without correction (no glasses) measured at 40 cm.
Measured: 3 months
Uncorrected Intermediate (66 cm) Visual Acuity
Visual acuity without correction (no glasses) measured at 66 cm.
Measured: 3 months
Uncorrected (4 m) Visual Acuity
Visual acuity without correction (no glasses) measured at 4 m.
Measured: 3 months
Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.
Measured: 3 months
Patient Reported Spectacle Independence Questionnaire
Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.
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 posted17 Mar 2017
- Study start17 Feb 2017
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cataract BilateralStudies 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Eyecare Physicians, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision, Abbott Medical Optics
- Responsible party
- Sponsor
- Investigators
- Kerry D. Solomon, MD, Study chair, Carolina Eyecare Physicians, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082599
- Sponsor's protocol ID
- CEP 2016-002
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2017
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT03082599
- Acronym / sponsor ID
- CEP 2016-002
- Conditions
- Cataract Bilateral, Astigmatism Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Carolina Eyecare Physicians, LLCUniversity, hospital or other
- Collaborators
- Science in Vision, Abbott Medical Optics
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emmetropia both eyes (OU) group | Active comparator | Device: Presbyopia and astigmatism correcting intraocular lensSymfony Toric IOL target refraction both eyes emmetropia (±0.25D). |
| Nanovision group | Experimental | Device: Presbyopia and astigmatism correcting intraocular lensSymfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
- Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
Key exclusion criteria (18 listed)
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
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 |
|---|---|---|
| Presbyopia and astigmatism correcting intraocular lensThe Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. | Device | Emmetropia both eyes (OU) group, Nanovision group |
Primary outcome
Binocular Distance-corrected Near (40 cm) Visual Acuity.
Time frame: 3 months
Visual acuity with correction (glasses) measured at 40 cm.
Reduction of Manifest Cylinder (Diopters).
Time frame: 3 months
5 secondary outcomes
Uncorrected Near (40 cm) Visual Acuity
Time frame: 3 months
Uncorrected Intermediate (66 cm) Visual Acuity
Time frame: 3 months
Uncorrected (4 m) Visual Acuity
Time frame: 3 months
Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
Time frame: 3 months
Patient Reported Spectacle Independence Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kerry D. Solomon, MD study chair
Carolina Eyecare Physicians, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presbyopia and astigmatism correcting intraocular lens in people with Cataract Bilateral and Astigmatism Bilateral, run by Carolina Eyecare Physicians, LLC at 4 sites in United States.
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 18 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Distance-corrected Near (40 cm) Visual Acuity. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 Jan 2020.