Synergy Lens Outcomes Evaluation

Last updated: August 29, 2023
Sponsor: Center For Sight
Overall Status: Completed

Phase

N/A

Condition

Presbyopia

Treatment

Tecnis Synergy IOL

Clinical Study ID

NCT05418153
CFS 21-001
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

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 segmentsurgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at CarolinaEyecare 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 inboth eyes.

Exclusion

Exclusion Criteria:

  1. Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis,and clinically-significant retinal pathology affecting the macula (with visual acuityworse than 20/32) and/or any other ocular findings that may, in the opinion of theinvestigator, 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 thatmay interfere with the interpretation of study results.
  14. Participation in (or current participation) any ophthalmic investigational drug orophthalmic device trial within the previous 30 days prior to the start date of thistrial.
  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 rupturedzonules, torn capsule, or vitrectomy.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Tecnis Synergy IOL
Phase:
Study Start date:
March 14, 2022
Estimated Completion Date:
November 22, 2022

Connect with a study center

  • Center For Sight

    Venice, Florida 34285
    United States

    Site Not Available

  • Carolina Eyecare Physicians

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

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