Symfony/Synergy IOL Combination Outcomes

Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched With the Symfony With Intelilight

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study that evaluated the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery showed good outcomes with high patient satisfaction and less dependance on glasses for intermediate and near activities. As technology evolves, new lens models are available in the market. The purpose of this study is to evaluate the latest EDOF and a hybrid multifocal lenses when combined.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Bilateral Cataract
• Intervention / Treatment: Device: Symfony & Synergy IOL combination

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Florida
    • Venice, Florida, United States, 34285
      • Center For Sight
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Helga Sandoval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from two ophthalmology clinics.

Description

Inclusion Criteria:

1. Subject is undergoing bilateral lens extraction with intraocular lens implantation of the Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye.
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 with topical anesthesia in both eyes within 2 to 30 days between surgeries
7. Subjects who require an IOL power in the range of +5.00 D to +34.0 D only.
8. Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane).
9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
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. History of chronic intraocular inflammation.
8. History of retinal detachment.
9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
10. Previous intraocular surgery.
11. Previous corneal refractive surgery (i.e. LASIK, photorefractive keratectomy, radial keratotomy).
12. Previous keratoplasty
13. Severe dry eye
14. Pupil abnormalities
15. Anesthesia other than topical or peribulbar anesthesia (i.e. retrobulbar, general, etc).
16. 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.
17. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symfony & Synergy IOL combination	Device: Symfony & Synergy IOL combination; The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular Defocus Curve	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Questionnaire	Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed	3 months
Spectacle Independence for Near Activities Questionnaire	Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.	3 months

Collaborators and Investigators

• Sponsor: Center For Sight
• Collaborators: Science in Vision

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: CFS-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No