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OpenTrials
Completed

NCT Number: NCT05604781

Symfony/Synergy IOL Combination Outcomes

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.

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Key information

Conditions

Bilateral Cataract Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center For Sight, Venice, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Binocular Defocus Curve

    Time frame: 3 months

Secondary outcomes

  1. Patient Satisfaction Questionnaire

    Time frame: 3 months

    Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed

  2. Spectacle Independence for Near Activities Questionnaire

    Time frame: 3 months

    Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.

Sponsors and collaborators

Lead sponsor

Center For Sight

Other

Collaborators

  • Science in Vision

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2022
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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