Symfony/Synergy IOL Combination Outcomes

NCT05604781 | Completed Results FDA Device

• 1 other identifier: CFS-22-001
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bilateral Cataract; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Binocular Defocus Curve

  3 months

Secondary Outcomes (2)

• Patient Satisfaction Questionnaire

  3 months

• Spectacle Independence for Near Activities Questionnaire

  3 months

Study Arms (1)

Symfony & Synergy IOL combination

Device: Symfony & Synergy IOL combination

Interventions

Symfony & Synergy IOL combination DEVICE

The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.

Symfony & Synergy IOL combination

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from two ophthalmology clinics.

You may qualify if:

• 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.
• 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 with topical anesthesia in both eyes within 2 to 30 days between surgeries
• Subjects who require an IOL power in the range of +5.00 D to +34.0 D only.
• Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane).
• Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if:

• 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.
• 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
• 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, photorefractive keratectomy, radial keratotomy).
• Previous keratoplasty
• Severe dry eye
• Pupil abnormalities
• Anesthesia other than topical or peribulbar anesthesia (i.e. retrobulbar, general, etc).

Sponsors & Collaborators

• Center For Sight: lead
• Science in Vision: collaborator

Study Sites (2)

Center For Sight

Venice, Florida, 34285, United States

Location

Helga Sandoval

Mt. Pleasant, South Carolina, 29464, United States

Location

Related Publications (1)

• Soscia WL, DeRojas JO, Mathews PM, Brutsky A, Solomon KD, Potvin R, Sandoval HP. Clinical performance after implantation of an EDOF intraocular lens in the dominant eye and a presbyopia-correcting intraocular lens in the nondominant eye. J Cataract Refract Surg. 2024 Jun 1;50(6):578-584. doi: 10.1097/j.jcrs.0000000000001412.

  PMID: 38305420 DERIVED

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Center For Sight

hsandoval@cepmd.com

8438813937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 3, 2022
• Study Start: October 17, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)