Bilateral CataractNCT05604781
Symfony/Synergy IOL Combination Outcomes
An observational study of Bilateral Cataract and Presbyopia, run by Center For Sight at 2 sites in United States.
Trial summary
Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bilateral Cataract, Presbyopia
- What is being tested?
- Symfony & Synergy IOL combination
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2022to 16 May 2023
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from two ophthalmology clinics.
Who may be able to join
- Subject is undergoing bilateral lens extraction with intraocular lens implantation of the Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye.
- Gender: Males and Females.
- Age: 50 years and older.
- 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 2 to 30 days between surgeries
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- Subjects who require an IOL power in the range of +5.00 D to +34.0 D only.
- Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane).
- 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
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- 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 corneal refractive surgery (i.e. LASIK, photorefractive keratectomy, radial keratotomy).
- Previous keratoplasty
- Severe dry eye
- Pupil abnormalities
- Anesthesia other than topical or peribulbar 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
2 sites in 1 country.
United States2 sites
Helga Sandoval
Mt. Pleasant, South Carolina, 29464
Center For Sight
Venice, Florida, 34285
About this study
Official title: Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched With the Symfony With Intelilight
Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study that evaluated the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.
- Conditions
- Bilateral Cataract, Presbyopia
- Being tested
- Symfony & Synergy IOL combination
- 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 & Synergy IOL combinationDevice
The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
| Study group | Role | What they receive |
|---|---|---|
| Symfony & Synergy IOL combination | Not described Receives: Device: Symfony & Synergy IOL combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Defocus Curve
Measured: 3 months
Secondary outcomes (2)
Patient Satisfaction Questionnaire
Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed
Measured: 3 months
Spectacle Independence for Near Activities Questionnaire
Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.
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 posted3 Nov 2022
- Study start17 Oct 2022
- Primary completion16 May 2023
- Study completion16 May 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bilateral 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center For Sight
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604781
- Sponsor's protocol ID
- CFS-22-001
- Status last verified
- Aug 2023
- First submitted
- 26 Oct 2022
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Soscia WL, DeRojas JO, Mathews PM, Brutsky A, Solomon KD, Potvin R, Sandoval HP. Clinical performance after implantation of an EDOF intraocular lens in the dominant eye and a presbyopia-correcting intraocular lens in the nondominant eye. J Cataract Refract Surg. 2024 Jun 1;50(6):578-584. doi: 10.1097/j.jcrs.0000000000001412.
PubMed 38305420
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched With the Symfony With Intelilight
- ClinicalTrials.gov ID
- NCT05604781
- Acronym / sponsor ID
- CFS-22-001
- Conditions
- Bilateral Cataract, Presbyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Center For SightUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study that evaluated the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symfony & Synergy IOL combination | – | Device: Symfony & Synergy IOL combination |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from two ophthalmology clinics.
Key inclusion criteria (9 listed)
- Subject is undergoing bilateral lens extraction with intraocular lens implantation of the Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye.
- Gender: Males and Females.
- Age: 50 years and older.
- 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.
Key exclusion criteria (17 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 |
|---|---|---|
| Symfony & Synergy IOL combinationThe Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye. | Device | Symfony & Synergy IOL combination |
Primary outcome
Binocular Defocus Curve
Time frame: 3 months
2 secondary outcomes
Patient Satisfaction Questionnaire
Time frame: 3 months
Spectacle Independence for Near Activities 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 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38305420Soscia WL, DeRojas JO, Mathews PM, Brutsky A, Solomon KD, Potvin R, Sandoval HP. Clinical performance after implantation of an EDOF intraocular lens in the dominant eye and a presbyopia-correcting intraocular lens in the nondominant eye. J Cataract Refract Surg. 2024 Jun 1;50(6):578-584. doi: 10.1097/j.jcrs.0000000000001412.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bilateral Cataract and Presbyopia, run by Center For Sight at 2 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 9 inclusion and 17 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 18 Mar 2024. 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 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 18 Mar 2024). 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 Defocus Curve (time frame: 3 months). 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 NCT05604781, which also lists 1 linked publication.
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 18 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.