Synergy Lens Outcomes Evaluation

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

Study Overview

• Status: Completed
• Conditions: Presbyopia; Pseudophakia
• Intervention / Treatment: Device: Tecnis Synergy IOL

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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)

Description

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 informed consent 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:

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. Clinically significant 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 investigational 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Synergy IOL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions	Visual acuity measured at 40 cm	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	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Participants will answer a questionnaire to determine the satisfaction with near activities. Possible answers include Completely, mostly, moderately, a little and not all satisfied.	Up to 1 year

Collaborators and Investigators

• Sponsor: Center For Sight
• Collaborators: Science in Vision

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Pseudophakia
• Other Study ID Numbers: CFS 21-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes