CataractNCT05541796
Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens
A study testing Intraocular lens in people with Cataract, run by George O. Waring IV at 1 site in United States.
Trial summary
Tecnis Symfony Optiblue (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus intraocular lens (IOL) that provides a continuous range of clear vision at far and intermediate. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 31 Dec 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older
- Requiring bilateral cataract surgery, wish to achieve spectacle independence.
- Are suitable candidates for Tecnis Synergy and Tecnis Symfony IOLs
- Have predicted postoperative astigmatism ≤ 0.75 D
- Willing to provide written informed consent and adhere to study requirements
Who cannot join
- History of ocular surgery, including laser refractive surgery
- History of ocular trauma
- Patients planning for any concomitant ocular procedure at the time of cataract surgery (including MIGS) other than incisional correction of astigmatism as the time of surgery
- Ocular comorbidities including glaucoma, macular degeneration, corneal scars, or any other condition that might limit the ability to achieve 20/20 visual acuity.
- Unwillingness to provide written informed consent,
- Disability to understand and/or fill the patient questionnaire,
- Pregnancy or lactation.
- Any patient who meets enrollment criteria but subsequently experiences an intraoperative complication or does not undergo surgery with implantation of the intended pair of IOLs will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Waring Vision Institute
Mt. Pleasant, South Carolina, 29464
About this study
Official title: Clinical Outcomes and Patient Satisfaction Following Implantation of Tecnis Synergy and Tecnis Symfony Intraocular Lens
Tecnis Symfony Optiblue (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus intraocular lens (IOL) that provides a continuous range of clear vision at far and intermediate. Tecnis Synergy™ IOL (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is another latest United States Food and Drug Administration (USFDA) approved IOL, designed to provide good acuity at far through near distances, reducing the need for spectacles. These IOLs are approved/licensed for use and are not investigational. The present study intends to evaluate the clinical outcomes and patient satisfaction following contralateral implantation of Tecnis Synergy and Symfony Optiblue in cataract patients. The investigator hypothesizes that the contralateral implantation of these two lenses will allow a good proportion of patients to be spectacle independent at distance, intermediate, and near. The findings of this study may help the surgeons make better decisions on the choice of IOL in the future.
Read the detailed description
Presbyopia-correcting intraocular lenses (IOLs), including multifocal and extended depth of focus (EDOF) IOLs, have revolutionized the field of refractive cataract surgery by providing good vision at multiple distances and spectacle independence. While multifocal IOLs provide good visual acuity at various distances, increased incidence of photic phenomena (haloes, glare, starbursts, etc.) associated with multifocal IOLs is a cause of dissatisfaction among patients. EDOF IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth-of-focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus minimizing the halo effect.
Recent developments in IOL technologies focus on finding the best compromise between the range of visual rehabilitation and the induction of postoperative photic phenomena and contrast sensitivity reduction. One of these developments is the Tecnis Synergy™ IOL, which combines an EDOF profile with a multifocal diffractive design, to obtain continuous high-contrast vision from far through near, even in low-lighting conditions (Tecnis Synergy, Johnson \& Johnson Vision, Santa Ana, CA, Unites States) without the visual gaps caused by the trifocal technology. Preliminary data with Tecnis Synergy IOLs in European populations are quite encouraging. In some cases, a combination of two different IOLs has been implanted to capitalize on the strengths and mitigate the weaknesses of each. Thus, the present study aims to evaluate the clinical outcomes and patient satisfaction following implantation of a combination of Tecnis Synergy and Tecnis Symfony OptiBlue IOLs in a US-based population of cataract surgery patients.
- Conditions
- Cataract
- Being tested
- Intraocular lens
- Keywords
- Cataract, Tecnis Synergy, Tecnis Symfony, presbyopia-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.
Intraocular lensDevice
Tecnis Symfony Optiblue (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus IOL that provides a continuous range of clear vision at far and intermediate.
Tecnis Synergy™ IOL (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is another latest United States Food and Drug Administration (USFDA) approved IOL, designed to provide good acuity at far through near distances, reducing the need for spectacles.
| Study group | Role | What they receive |
|---|---|---|
| Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs | Other | Non-comparative study involving contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs. Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular distance-corrected intermediate visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).
Measured: Postoperative 6 months
Binocular distance-corrected near visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).
Measured: Postoperative 6 months
Binocular distance-corrected very near visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected very near visual acuity (DCVNVA, 33 cm).
Measured: Postoperative 6 months
Secondary outcomes (6)
Binocular uncorrected intermediate visual acuity under photopic conditions
Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm
Measured: Postoperative 6 months
Binocular uncorrected near visual acuity under photopic conditions
Mean logMAR binocular uncorrected near visual acuity measured at 40 cm
Measured: Postoperative 6 months
Binocular uncorrected very near visual acuity under photopic conditions
Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm
Measured: Postoperative 6 months
Binocular uncorrected distance visual acuity under photopic conditions
Mean logMAR binocular uncorrected distance visual acuity
Measured: Postoperative 6 months
Subjective assessment of patient satisfaction and other patient-reported outcomes using visual symptoms questionnaire (PRVSQ)
Subjective assessment of patient satisfaction with the surgery and other patient-reported outcomes using a patient-reported visual symptoms questionnaire (PRVSQ)
Measured: Postoperative 6 months
Subjective assessment of patient satisfaction and other patient-reported outcomes using spectacle independence questionnaire (PRSIQ)
Subjective assessment of patient satisfaction with the surgery and other patient-reported outcomes using a patient-reported spectacle independence questionnaire (PRSIQ)
Measured: Postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start19 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Model description
- Prospective, non-comparative, interventional, phase 4 study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- George O. Waring IV
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Responsible party
- Sponsor-investigator, George O. Waring IV, Waring Vision Institute
- Investigators
- George O Waring IV, MD FACS, Principal investigator, Waring Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541796
- Sponsor's protocol ID
- WVI/2022/01
- Status last verified
- Jul 2024
- First submitted
- 30 Aug 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Patient Satisfaction Following Implantation of Tecnis Synergy and Tecnis Symfony Intraocular Lens
- ClinicalTrials.gov ID
- NCT05541796
- Acronym / sponsor ID
- WVI/2022/01
- Conditions
- Cataract
- Keywords
- Cataract, Tecnis Synergy, Tecnis Symfony, presbyopia-correcting intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- George O. Waring IVUniversity, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Sep 2022 (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.
Tecnis Symfony Optiblue (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus intraocular lens (IOL) that provides a continuous range of clear vision at far and intermediate. Tecnis Synergy™ IOL (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is another latest United States Food and Drug Administration (USFDA) approved IOL, designed to provide good acuity at far through near distances, reducing the need for spectacles. These IOLs are approved/licensed for use and are not investigational. The present study intends to evaluate the clinical outcomes and patient satisfaction following contralateral implantation of Tecnis Synergy and Symfony Optiblue in cataract patients. The investigator hypothesizes that the contralateral implantation of these two lenses will allow a good proportion of patients to be spectacle independent at distance, intermediate, and near. The findings of this study may help the surgeons make better decisions on the choice of IOL in the future.
Detailed description
Presbyopia-correcting intraocular lenses (IOLs), including multifocal and extended depth of focus (EDOF) IOLs, have revolutionized the field of refractive cataract surgery by providing good vision at multiple distances and spectacle independence. While multifocal IOLs provide good visual acuity at various distances, increased incidence of photic phenomena (haloes, glare, starbursts, etc.) associated with multifocal IOLs is a cause of dissatisfaction among patients. EDOF IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth-of-focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus minimizing the halo effect.
Recent developments in IOL technologies focus on finding the best compromise between the range of visual rehabilitation and the induction of postoperative photic phenomena and contrast sensitivity reduction. One of these developments is the Tecnis Synergy™ IOL, which combines an EDOF profile with a multifocal diffractive design, to obtain continuous high-contrast vision from far through near, even in low-lighting conditions (Tecnis Synergy, Johnson \& Johnson Vision, Santa Ana, CA, Unites States) without the visual gaps caused by the trifocal technology. Preliminary data with Tecnis Synergy IOLs in European populations are quite encouraging. In some cases, a combination of two different IOLs has been implanted to capitalize on the strengths and mitigate the weaknesses of each. Thus, the present study aims to evaluate the clinical outcomes and patient satisfaction following implantation of a combination of Tecnis Synergy and Tecnis Symfony OptiBlue IOLs in a US-based population of cataract surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative, interventional, phase 4 study
| Arm | Type | Receives |
|---|---|---|
| Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs | Other | Device: Intraocular lensNon-comparative study involving contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 years or older
- Requiring bilateral cataract surgery, wish to achieve spectacle independence.
- Are suitable candidates for Tecnis Synergy and Tecnis Symfony IOLs
- Have predicted postoperative astigmatism ≤ 0.75 D
- Willing to provide written informed consent and adhere to study requirements
Key exclusion criteria (8 listed)
- History of ocular surgery, including laser refractive surgery
- History of ocular trauma
- Patients planning for any concomitant ocular procedure at the time of cataract surgery (including MIGS) other than incisional correction of astigmatism as the time of surgery
- Ocular comorbidities including glaucoma, macular degeneration, corneal scars, or any other condition that might limit the ability to achieve 20/20 visual acuity.
- Unwillingness to provide written informed consent,
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 |
|---|---|---|
| Intraocular lensTecnis Symfony Optiblue (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus IOL that provides a continuous range of clear vision at far and intermediate. Tecnis Synergy™ IOL (Johnson \& Johnson Vision, Santa Ana, CA, Unites States) is another latest United States Food and Drug Administration (USFDA) approved IOL, designed to provide good acuity at far through near distances, reducing the need for spectacles. | Device | Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs |
Primary outcome
Binocular distance-corrected intermediate visual acuity under photopic conditions.
Time frame: Postoperative 6 months
Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).
Binocular distance-corrected near visual acuity under photopic conditions.
Time frame: Postoperative 6 months
Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).
Binocular distance-corrected very near visual acuity under photopic conditions.
Time frame: Postoperative 6 months
Mean logMAR binocular distance-corrected very near visual acuity (DCVNVA, 33 cm).
6 secondary outcomes
Binocular uncorrected intermediate visual acuity under photopic conditions
Time frame: Postoperative 6 months
Binocular uncorrected near visual acuity under photopic conditions
Time frame: Postoperative 6 months
Binocular uncorrected very near visual acuity under photopic conditions
Time frame: Postoperative 6 months
Binocular uncorrected distance visual acuity under photopic conditions
Time frame: Postoperative 6 months
Subjective assessment of patient satisfaction and other patient-reported outcomes using visual symptoms questionnaire (PRVSQ)
Time frame: Postoperative 6 months
Subjective assessment of patient satisfaction and other patient-reported outcomes using spectacle independence questionnaire (PRSIQ)
Time frame: Postoperative 6 months
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 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
George O Waring IV, MD FACS principal investigator
Waring Vision Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens in people with Cataract, run by George O. Waring IV at 1 site 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 5 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: finished, as of the sponsor's last update on 23 Jul 2024. 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 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?
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 distance-corrected intermediate visual acuity under photopic conditions. (time frame: Postoperative 6 months). The study lists 3 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 23 Jul 2024.