Symfony/Synergy IOL Combination Outcomes

Last updated: August 31, 2023
Sponsor: Center For Sight
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Presbyopia

Treatment

Symfony & Synergy IOL combination

Clinical Study ID

NCT05604781
CFS-22-001
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is undergoing bilateral lens extraction with intraocular lens implantation ofthe Symfony with InteliLight in the dominant eye and a Synergy in the non-dominanteye.
  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 eyeswithin 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 cornealplane).
  9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in botheyes.

Exclusion

Exclusion Criteria:

  1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferativediabetic 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 nerveatrophy, macular degeneration (with anticipated best postoperative visual acuity lessthan 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 thezonules.
  10. Previous intraocular surgery.
  11. Previous corneal refractive surgery (i.e. LASIK, photorefractive keratectomy, radialkeratotomy).
  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 thatmay increase the risk associated with study participation or may interfere with theinterpretation of study results.
  17. Participation in (or current participation) any ophthalmic investigational drug orophthalmic device trial within the previous 30 days prior to the start date of thistrial.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Symfony & Synergy IOL combination
Phase:
Study Start date:
October 17, 2022
Estimated Completion Date:
May 16, 2023

Connect with a study center

  • Center For Sight

    Venice, Florida 34285
    United States

    Site Not Available

  • Helga Sandoval

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

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