Symfony vs Vivity in Dim Light

Phase 4

Recruiting

• Conditions: Cataract
• Interventions: Device: Symfony IOL; Device: Vivity IOL

• Registration Number: NCT06229106
• Lead Sponsor: Carolina Eyecare Physicians, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symfony IOL	Symfony IOL	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	Vivity IOL	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 Outcome Measures

Name	Time	Method
Binocular distance corrected intermediate visual acuity at 66 cm under mesopic conditions.	3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Binocular low contrast distance visual acuity under mesopic conditions	3 months after surgery
Binocular distance corrected intermediate visual acuity at 40 cm under mesopic conditions.	3 months after surgery

Trial Locations

Locations (2)

Carolina Eyecare Physicians, LLC; 🇺🇸 Mount Pleasant, South Carolina, United States

Center for Sight; 🇺🇸 Sarasota, Florida, United States