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OpenTrials
Completed

NCT Number: NCT03771274

Tecnis ZLB00 & Symfony Intraocular Lens 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, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate 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.

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Key information

Conditions

Cataract Bilateral Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
  • 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 6-15 days between surgeries.
  • Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
  • Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion criteria

  • Contraindication for a presbyopia correcting IOL.
  • Subjects with severe astigmatism in the non-dominant eye
  • 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 refractive surgery.
  • Previous keratoplasty
  • Severe dry eye
  • Pupil abnormalities
  • Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than yttrium aluminum garnet (YAG) capsulotomy, i.e. LASIK)
  • Anesthesia other than topical 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

Tecnis ZLB00 & Symfony IOL

Device

The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.

Primary outcomes

  1. Binocular Uncorrected Near (40 cm) Visual Acuity.

    Time frame: 3 months

    Visual acuity measured at 40 cm without wearing any correction.

Secondary outcomes

  1. Patient Visual Satisfaction After Cataract Surgery: Questionnaire

    Time frame: 3 months

    Patient's overall satisfaction with their vision after cataract surgery assessed by asking the following question: "Taking all things into account, how satisfied or dissatisfied are you with your vision WITHOUT glasses or contacts with your near vision". Possible answers are: Completely satisfied and mostly satisfied, moderately satisfied, a little satisfied or not at all satisfied.

  2. Spectacle Independence: Questionnaire

    Time frame: 3 months

    Patient's spectacle independence was assessed using the "Patient Reported Spectacle Independence Questionnaire (PRSIQ) which includes the following questions: 1. During the LAST 7 DAYS, did you need glasses or contacts for near. Possible answers: Yes No.

  3. Number of Participants With Visual Symptoms

    Time frame: 3 months

    Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.

Sponsors and collaborators

Lead sponsor

Carolina Eyecare Physicians, LLC

Other

Collaborators

  • Johnson & Johnson Surgical Vision, Inc.
  • Science in Vision

Registry information

Official study title

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2018
Registry last updated
Aug 10, 2020

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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