Symfony vs Vivity in Dim Light

C

Carolina Eyecare Physicians, LLC

Status and phase

Enrolling
Phase 4

Conditions

Cataract

Treatments

Device: Vivity IOL
Device: Symfony IOL

Study type

Interventional

Funder types

Other

Identifiers

NCT06229106
CEP 23-001

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with 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 days between surgeries.
  7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

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 weaken the 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 with visual 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 intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK)
  18. Any clinically significant, serious, or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
  19. 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

Symfony IOL
Active Comparator group
Description:
The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Treatment:
Device: Symfony IOL
Vivity IOL
Active Comparator group
Description:
The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.
Treatment:
Device: Vivity IOL

Trial contacts and locations

2

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Central trial contact

Helga P. Sandoval

Data sourced from clinicaltrials.gov

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