ClinicalTrials.gg
CompletedNCT05418153Updated Mar 18, 2024Results posted

Synergy Lens Outcomes Evaluation

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

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
52
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Presbyopia
  • Pseudophakia
03

In context

Presbyopia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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)

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.

Inclusion criteria

  1. Age: 18 years and older.
  2. Gender: Males and Females.
  3. Uneventful bilateral lens extraction
  4. 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.
  5. Willing and able to provide written for participation in the study.
  6. Willing and able to comply with scheduled visit and study examination procedures.
  7. At least 3 months postoperative from second eye IOL implantation.
  8. Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Uncontrolled diabetes.
  3. Use of any systemic or topical drug known to interfere with visual performance.
  4. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  5. corneal dystrophy.
  6. Irregular astigmatism.
  7. History of chronic intraocular inflammation.
  8. Previous intraocular surgery.
  9. Previous keratoplasty
  10. Previous refractive surgery.
  11. Severe dry eye
  12. Pupil abnormalities
  13. Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
  14. Participation in (or current participation) any ophthalmic drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
  15. Best-corrected distance visual acuity worse than 20/32 in each eye.
  16. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  17. Abnormal iris
  18. Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • Synergy IOL

    Patients implanted with the Synergy IOL in both eyes.

    Device: Tecnis Synergy IOL

Interventions

  • DeviceTecnis Synergy IOL

    Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

06

What researchers measure

Primary outcomes

  1. Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions

    Visual acuity measured at 40 cm

    Time frame: Up to 1 year

  2. 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

07

Results

Posted Mar 18, 2024

Participant flow

Participant flow — Overall Study
MilestoneSynergy IOL
Started52
Completed52
Not completed0

Outcome measures

PrimaryBinocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions

Visual acuity measured at 40 cm

Time frame:
Up to 1 year
Reported as:
Mean · logMAR
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions
logMARSynergy IOL
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions0.01 ± 0.07
PrimaryBinocular 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
Reported as:
Mean · logMAR
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions
logMARSynergy IOL
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions0.21 ± 0.12

Adverse events

Collected over Day of study visit. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Synergy IOL0/52 (0%)0/52 (0%)0/52 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Synergy IOL
<=18 years0
Between 18 and 65 years21
>=65 years31
Age, Continuous
Age, Continuous(years)Synergy IOL
Mean66 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)Synergy IOL
Female32
Male20
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Synergy IOL
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White45
More than one race0
Unknown or Not Reported7
Region of Enrollment
Region of Enrollment(Participants)Synergy IOL
United States52
08

Study locations

2 sites
  • Center For Sight
    Venice, Florida 34285, United States
  • Carolina Eyecare Physicians
    Mount Pleasant, South Carolina 29464, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05418153
Lead sponsor
Center For Sight
Collaborators
Science in Vision
Responsible party
Sponsor
First posted
Jun 14, 2022
Start date
Mar 14, 2022
Primary completion
Nov 22, 2022
Completion
Nov 22, 2022
Results posted
Mar 18, 2024
Last update
Mar 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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