Clinical trial NCT06229106: Symfony vs Vivity in Dim Light
Official title: Evaluation of the Symfony With Optiblue Intraocular Lens Compared to The Vivity IOL Under Mesopic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Carolina Eyecare Physicians, LLC
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2024-01-29
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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:

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.

Primary outcomes:
measure: Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.
timeFrame: 3 months after surgery
measure: Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
Study officials:
References: