Phase 4
N=64
Symfony vs Vivity in Dim Light
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT06229106 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. — 0.27; 0.32 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Symfony IOL (Device); Vivity IOL (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Carolina Eyecare Physicians, LLC
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. |
0.27; 0.32 | — |
| SECONDARY Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. |
0.54; 0.52 | — |
| SECONDARY Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions |
0.44; 0.43 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT06229106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.