CataractNCT06500416
Visual Outcomes of Tecnis Symfony Opti-Blue EDOF Intraocular Lens (IOL)
A study testing Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in people with Cataract, run by Coastal Eye Surgeons PLLC at 1 site in United States.
Trial summary
Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Jan 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements.
Who cannot join
- Corneal dystrophies
- Central corneal scarring
- Keratoconus
- Proliferative diabetic retinopathy
- Exudative macular degeneration
- Zonular weakness
Show all 13Show fewer
- Pseudoexfoliation
- Fovea-involving atrophy
- Severe dry eye
- Amblyopia
- Pupil abnormalities
- Need for an IOL outside the range of +5.0 D to +34.0 D or cylinder power over 3.75 D
- Patients who have undergone prior cataract surgery and IOL implantation in either eye; had prior corneal refractive or corneal transplantation surgery; diabetics post-vitrectomy; or who have a history of macula-off retinal detachment will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal eye surgeons
Greenwich, Connecticut, 06830
Omar Shakir, MD, MBA, 321-960-2664, omarshakir@coastaleyesurgeons.com
Martha Kaczynski, 203-919-2253, marthakacz@gmail.com
About this study
Official title: Visual Outcomes Following Implantation of Tecnis Symfony Opti-Blue EDOF IOL in Patients With Mild to Moderate Retinal Ocular Comorbidities
Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.
Read the detailed description
Extended depth of focus (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 generating a lower incidence of halos and glare. The Tecnis Symfony (Johnson \& Johnson Vision) EDOF IOL incorporates a diffractive echelette design to increase the range of vision. The achromatic technology corrects chromatic aberration and increases retinal image contrast.
The latest version of the Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. As such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering Tecnis Symfony Optiblue EDOF IOLs in patients with retinal comorbidities undergoing cataract surgery.
- Conditions
- Cataract
- Being tested
- Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL
- Keywords
- Retinal comorbidity, Tecnis Symfony Optiblue 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.
Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOLDevice
Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts.
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL | Experimental | This prospective, non-comparative, interventional study will include 15 cataract patients (30 eyes) who will undergo femtosecond laser-assisted cataract surgery with implantation of the Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in both eyes. Receives: Device: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected visual acuity at distance
Mean binocular uncorrected visual acuity at distance
Measured: 3 months
Binocular uncorrected visual acuity at intermediate
Mean binocular uncorrected visual acuity at intermediate
Measured: 3 months
Binocular uncorrected visual acuity at near
Mean binocular uncorrected visual acuity at near
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 posted15 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (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
- Model description
- This prospective, non-comparative, interventional study will include 15 cataract patients (30 eyes) who will undergo femtosecond laser-assisted cataract surgery with implantation of the Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in both eyes.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coastal Eye Surgeons PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500416
- Sponsor's protocol ID
- CES/OS/01/2023
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes Following Implantation of Tecnis Symfony Opti-Blue EDOF IOL in Patients With Mild to Moderate Retinal Ocular Comorbidities
- ClinicalTrials.gov ID
- NCT06500416
- Acronym / sponsor ID
- CES/OS/01/2023
- Conditions
- Cataract
- Keywords
- Retinal comorbidity, Tecnis Symfony Optiblue Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Coastal Eye Surgeons PLLCUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Jul 2024 (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 EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.
Detailed description
Extended depth of focus (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 generating a lower incidence of halos and glare. The Tecnis Symfony (Johnson \& Johnson Vision) EDOF IOL incorporates a diffractive echelette design to increase the range of vision. The achromatic technology corrects chromatic aberration and increases retinal image contrast.
The latest version of the Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. As such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering Tecnis Symfony Optiblue EDOF IOLs in patients with retinal comorbidities undergoing cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective, non-comparative, interventional study will include 15 cataract patients (30 eyes) who will undergo femtosecond laser-assisted cataract surgery with implantation of the Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in both eyes.
| Arm | Type | Receives |
|---|---|---|
| Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL | Experimental | Device: Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOLThis prospective, non-comparative, interventional study will include 15 cataract patients (30 eyes) who will undergo femtosecond laser-assisted cataract surgery with implantation of the Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in both eyes. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements.
Key exclusion criteria (13 listed)
- Corneal dystrophies
- Central corneal scarring
- Keratoconus
- Proliferative diabetic retinopathy
- Exudative macular degeneration
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 |
|---|---|---|
| Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOLTecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. | Device | Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL |
Primary outcome
Binocular uncorrected visual acuity at distance
Time frame: 3 months
Mean binocular uncorrected visual acuity at distance
Binocular uncorrected visual acuity at intermediate
Time frame: 3 months
Mean binocular uncorrected visual acuity at intermediate
Binocular uncorrected visual acuity at near
Time frame: 3 months
Mean binocular uncorrected visual acuity at near
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL in people with Cataract, run by Coastal Eye Surgeons PLLC 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 1 inclusion and 13 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 9 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Shakir, MD, MBA (321-960-2664, omarshakir@coastaleyesurgeons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular uncorrected visual acuity at distance (time frame: 3 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 9 Aug 2024.