Symfony vs Vivity in Dim Light

Last updated: January 24, 2025
Sponsor: Carolina Eyecare Physicians, LLC
Overall Status: Completed

Phase

4

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

Symfony IOL

Vivity IOL

Clinical Study ID

NCT06229106
CEP 23-001
  • Ages > 50
  • All Genders

Study Summary

The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is undergoing bilateral lens extraction with implantation of an EDOF IOLwith a target refraction of plano OU.

  2. Gender: Males and Females.

  3. Age: 50 years and older.

  4. Willing and able to provide written informed consent for participation in the study

  5. Willing and able to comply with scheduled visits and other study procedures.

  6. Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 daysbetween surgeries.

  7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better inboth eyes.

Exclusion

Exclusion Criteria:

  1. Severe preoperative ocular pathology

  2. Uncontrolled diabetes.

  3. Use of any systemic or topical drug known to interfere with visual performance.

  4. Contact lens use during the active treatment portion of the trial.

  5. Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.

  6. Clinically significant corneal dystrophy.

  7. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus,corneal opacities.

  8. History of chronic intraocular inflammation.

  9. History of retinal detachment.

  10. Pseudoexfoliation syndrome or any other condition that has the potential to weakenthe zonules.

  11. Previous intraocular surgery.

  12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK).

  13. Subject who declined any type of presbyopia correcting IOL due to concerns withvisual disturbances (i.e., halos)

  14. Previous keratoplasty

  15. Severe dry eye

  16. Pupil abnormalities

  17. Subject who may reasonably be expected to require a secondary surgical interventionat any time during the study (other than YAG capsulotomy, i.e., LASIK)

  18. Any clinically significant, serious, or severe medical or psychiatric condition thatmay increase the risk associated with study participation or may interfere with theinterpretation of study results.

  19. Participation in (or current participation) any ophthalmic investigational drug orophthalmic device trial within the previous 30 days prior to the start date of thistrial.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Symfony IOL
Phase: 4
Study Start date:
December 01, 2023
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Center for Sight

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Carolina Eyecare Physicians, LLC

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

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