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Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

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ClinicalTrials.gov Identifier: NCT03771274
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Science in Vision
Johnson & Johnson Surgical Vision, Inc.
Information provided by (Responsible Party):
Carolina Eyecare Physicians, LLC

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, 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.

Condition or disease Intervention/treatment Phase
Cataract Bilateral Presbyopia Device: Tecnis ZLB00 & Symfony IOL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Tecnis ZLB00 & Symfony IOL
The Tecnis multifocal ZLB00 and the Symfony IOLs are presbyopia correcting lenses designed to improve the vision at distance, intermediate and near reducing the need for glasses in patients undergoing cataract surgery.
Device: Tecnis ZLB00 & Symfony IOL
The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.




Primary Outcome Measures :
  1. Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 1 month ]
    Visual acuity measured at 40 cm using the distance-correction if needed.

  2. Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 3 months ]
    Visual acuity measured at 40 cm using the distance-correction if needed.


Secondary Outcome Measures :
  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". Possible answers are: Completely satisfied, mostly satisfied, moderately satisfied, a little satisfied, not at all satisfied.

  2. Spectacle independence: questionnaire [ Time Frame: 3 months ]
    Patient's spectacle independence will be 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. Possible answers: Yes No. 2. During the LAST 7 DAYS, how often did you wear glasses or contacts and 3. During the LAST 7 DAYS, were you able to function comfortably WITHOUT glasses or contacts. Questions 2 and 3 possible answers are: All of the time, Most of the time, Some of the time, A little of the time, None of the time

  3. Visual symptoms [ Time Frame: 3 months ]
    Patient's reported visual symptoms



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
  2. Willing and able to provide written informed consent for participation in the study
  3. Willing and able to comply with scheduled visits and other study procedures.
  4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
  5. Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
  6. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

  1. Contraindication for a presbyopia correcting IOL.
  2. Subjects with severe astigmatism in the non-dominant eye
  3. Uncontrolled diabetes.
  4. Use of any systemic or topical drug known to interfere with visual performance.
  5. Contact lens use during the active treatment portion of the trial.
  6. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  7. Clinically significant corneal dystrophy
  8. History of chronic intraocular inflammation.
  9. History of retinal detachment.
  10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  11. Previous intraocular surgery.
  12. Previous refractive surgery.
  13. Previous keratoplasty
  14. Severe dry eye
  15. Pupil abnormalities
  16. 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)
  17. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
  18. 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.
  19. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771274


Contacts
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Contact: Helga P Sandoval, MD, MSCR 8438813937 helga.sandoval@carolinaeyecare.com

Locations
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United States, South Carolina
Carolina Eyecare Physicians, LLC Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Helga P Sandoval, MD, MSCR         
Sponsors and Collaborators
Carolina Eyecare Physicians, LLC
Science in Vision
Johnson & Johnson Surgical Vision, Inc.

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Responsible Party: Carolina Eyecare Physicians, LLC
ClinicalTrials.gov Identifier: NCT03771274     History of Changes
Other Study ID Numbers: CEP18-002
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors