PresbyopiaNCT05418153
Synergy Lens Outcomes Evaluation
An observational study of Presbyopia and Pseudophakia, run by Center For Sight at 2 sites in United States.
Trial summary
This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia, Pseudophakia
- What is being tested?
- Tecnis Synergy IOL
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2022to 22 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent routine, uneventful cataract surgery with implantation of the Synergy lens in both eyes between 01June2021 and 31Dec2021 at Center For Sight (Sarasota, FL) and Carolina Eyecare Physicians (Charleston, SC)
Who may be able to join
- Age: 18 years and older.
- Gender: Males and Females.
- Uneventful bilateral lens extraction
- Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December 2021.
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visit and study examination procedures.
- At least 3 months postoperative from second eye IOL implantation.
- Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Who cannot join
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy.
- Irregular astigmatism.
Show all 18Show fewer
- History of chronic intraocular inflammation.
- Previous intraocular surgery.
- Previous keratoplasty
- Previous refractive surgery.
- Severe dry eye
- Pupil abnormalities
- Any clinically significant, serious or severe medical or psychiatric condition that 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.
- Best-corrected distance visual acuity worse than 20/32 in each eye.
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Abnormal iris
- Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
Center For Sight
Venice, Florida, 34285
About this study
Official title: Evaluating the New Synergy IOL - First 7 Months Data From Two US Centers
This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA
- Conditions
- Presbyopia, Pseudophakia
- Being tested
- Tecnis Synergy IOL
- Medical subject headings
- Presbyopia, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis Synergy IOLDevice
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Synergy IOL | Patients implanted with the Synergy IOL in both eyes. Receives: Device: Tecnis Synergy IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
Visual acuity measured at 40 cm
Measured: Up to 1 year
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
Visual acuity measured at 40 cm under dim light
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start14 Mar 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
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 PresbyopiaStudies 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
- Cross-sectional
- Enrolment
- 52 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
- NCT05418153
- Sponsor's protocol ID
- CFS 21-001
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 the New Synergy IOL - First 7 Months Data From Two US Centers
- ClinicalTrials.gov ID
- NCT05418153
- Acronym / sponsor ID
- CFS 21-001
- Conditions
- Presbyopia, Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Center For SightUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 14 Jun 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.
This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synergy IOL | – | Device: Tecnis Synergy IOLPatients implanted with the Synergy IOL in both eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent routine, uneventful cataract surgery with implantation of the Synergy lens in both eyes between 01June2021 and 31Dec2021 at Center For Sight (Sarasota, FL) and Carolina Eyecare Physicians (Charleston, SC)
Key inclusion criteria (8 listed)
- Age: 18 years and older.
- Gender: Males and Females.
- Uneventful bilateral lens extraction
- Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December 2021.
- Willing and able to provide written informed consent for participation in the study.
Key exclusion criteria (18 listed)
- Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy.
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 Synergy IOLIntraocular lens replaces the natural lens removed during cataract surgery in both eyes. | Device | Synergy IOL |
Primary outcome
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
Time frame: Up to 1 year
Visual acuity measured at 40 cm
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
Time frame: Up to 1 year
Visual acuity measured at 40 cm under dim light
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.
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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 Presbyopia and Pseudophakia, 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 8 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 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 Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions (time frame: Up to 1 year). 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 18 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.