An observational study in Presbyopia and Pseudophakia, sponsored by Center For Sight. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Center For Sight · Observational
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
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 52 is below the median of 88 across 52 observational studies indexed under Presbyopia.
Browse Presbyopia studies →Center For Sight is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients implanted with the Synergy IOL in both eyes.
Device: Tecnis Synergy IOL
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
Visual acuity measured at 40 cm
Time frame: 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
Time frame: Up to 1 year
| Milestone | Synergy IOL |
|---|---|
| Started | 52 |
| Completed | 52 |
| Not completed | 0 |
Visual acuity measured at 40 cm
| logMAR | Synergy IOL |
|---|---|
| Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions | 0.01 ± 0.07 |
Visual acuity measured at 40 cm under dim light
| logMAR | Synergy IOL |
|---|---|
| Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions | 0.21 ± 0.12 |
Collected over Day of study visit. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Synergy IOL | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Categorical(Participants) | Synergy IOL |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 21 |
| >=65 years | 31 |
| Age, Continuous(years) | Synergy IOL |
|---|---|
| Mean | 66 ± 8 |
| Sex: Female, Male(Participants) | Synergy IOL |
|---|---|
| Female | 32 |
| Male | 20 |
| Race (NIH/OMB)(Participants) | Synergy IOL |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 45 |
| More than one race | 0 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(Participants) | Synergy IOL |
|---|---|
| United States | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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