Synergy Lens Outcomes Evaluation

Center For Sight (Other)
Overall Status
Recruiting ID
Science in Vision (Other)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Tecnis Synergy IOL

Study Design

Study Type:
Anticipated Enrollment :
100 participants
Observational Model:
Time Perspective:
Official Title:
Evaluating the New Synergy IOL - First 7 Months Data From Two US Centers
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Binocular distance corrected near visual acuity at 40 cm under photopic conditions [Up to 1 year]

    Visual acuity measured at 40 cm

  2. Binocular distance corrected near visual acuity at 40 cm under mesopic conditions [Up to 1 year]

    Visual acuity measured at 40 cm under dim light

Secondary Outcome Measures

  1. Patient satisfaction [Up to 1 year]

    Participants will answer a questionnaire to determine the satisfaction with near activities. Possible answers include Completely, mostly, moderately, a little and not all satisfied.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Center For Sight Venice Florida United States 34285
2 Carolina Eyecare Physicians Mount Pleasant South Carolina United States 29464

Sponsors and Collaborators

  • Center For Sight
  • Science in Vision


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Center For Sight Identifier:
Other Study ID Numbers:
  • CFS 21-001
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022