Symfony vs Vivity in Dim Light

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229106
• Other study ID #: CEP 23-001
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Carolina Eyecare Physicians, LLC
• Contact: Helga P. Sandoval
• Phone: 8438813937
• Email: hps[@]cepmd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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
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.

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina
United States	Center for Sight	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular distance corrected intermediate visual acuity at 66 cm under mesopic conditions.		3 months after surgery
Secondary	Binocular distance corrected intermediate visual acuity at 40 cm under mesopic conditions.		3 months after surgery
Secondary	Binocular low contrast distance visual acuity under mesopic conditions		3 months after surgery