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OpenTrials
Completed

NCT Number: NCT06229106

Symfony vs Vivity in Dim Light

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Sight, Sarasota, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU.
  • Gender: Males and Females.
  • Age: 50 years and older.
  • Willing and able to provide written informed consent for participation in the study
  • Willing and able to comply with scheduled visits and other study procedures.
  • Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries.
  • Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion criteria

  • Severe preoperative ocular pathology
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Contact lens use during the active treatment portion of the trial.
  • Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.
  • Clinically significant corneal dystrophy.
  • Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.
  • History of chronic intraocular inflammation.
  • History of retinal detachment.
  • Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  • Previous intraocular surgery.
  • Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
  • Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)
  • Previous keratoplasty
  • Severe dry eye
  • Pupil abnormalities
  • 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)
  • 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.
  • 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.

Treatment and study plan

Symfony IOL

Device

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.

Vivity IOL

Device

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.

Primary outcomes

  1. Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.

    Time frame: 3 months after surgery

    logMAR visual acuity

Secondary outcomes

  1. Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.

    Time frame: 3 months after surgery

  2. Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions

    Time frame: 3 months after surgery

    Visual acuity measured at 4 m

Sponsors and collaborators

Lead sponsor

Carolina Eyecare Physicians, LLC

Other

Collaborators

  • Science in Vision

Registry information

Official study title

Evaluation of the Symfony With Optiblue Intraocular Lens Compared to The Vivity IOL Under Mesopic Conditions

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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