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Symfony Toric Intraocular Lens Visual Outcomes

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ClinicalTrials.gov Identifier: NCT03082599
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Science in Vision
Abbott Medical Optics
Information provided by (Responsible Party):
Carolina Eyecare Physicians, LLC

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date June 20, 2018
Actual Study Start Date  ICMJE February 17, 2017
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 1 months ]
  • Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 3 months ]
  • Reduction of manifest cylinder (diopters). [ Time Frame: 1 month ]
  • Reduction of manifest cylinder (diopters). [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03082599 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • Uncorrected and distance-corrected near (40 cm) visual acuity [ Time Frame: 1 month ]
  • Uncorrected and distance-corrected near (40 cm) visual acuity [ Time Frame: 3 months ]
  • Uncorrected and distance-corrected intermediate (66 cm) visual acuity [ Time Frame: 1 month ]
  • Uncorrected and distance-corrected intermediate (66 cm) visual acuity [ Time Frame: 3 months ]
  • Uncorrected and best-corrected distance (4 m) visual acuity [ Time Frame: 1 month ]
  • Uncorrected and best-corrected distance (4 m) visual acuity [ Time Frame: 3 months ]
  • Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [ Time Frame: 1 month ]
  • Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [ Time Frame: 3 months ]
  • Patient Reported Spectacle Independence Questionnaire [ Time Frame: 1 month ]
  • Patient Reported Spectacle Independence Questionnaire [ Time Frame: 3 months ]
  • Change in IOL orientation (in degrees) from surgery to 3 months postoperative [ Time Frame: 3 months ]
    Toric IOL stability from time of surgery to 3 months postoperative
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Uncorrected and distance-corrected near (40 cm) visual acuity [ Time Frame: 1 month ]
  • Uncorrected and distance-corrected near (40 cm) visual acuity [ Time Frame: 3 months ]
  • Uncorrected and distance-corrected intermediate (66 cm) visual acuity [ Time Frame: 1 month ]
  • Uncorrected and distance-corrected intermediate (66 cm) visual acuity [ Time Frame: 3 months ]
  • Uncorrected and best-corrected distance (4 m) visual acuity [ Time Frame: 1 month ]
  • Uncorrected and best-corrected distance (4 m) visual acuity [ Time Frame: 3 months ]
  • Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [ Time Frame: 1 month ]
  • Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [ Time Frame: 3 months ]
  • Patient Reported Spectacle Independence Questionnaire [ Time Frame: 1 month ]
  • Patient Reported Spectacle Independence Questionnaire [ Time Frame: 3 months ]
  • Toric IOL stability from time of surgery to 3 months postoperative [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2017)
  • Residual mean spherical equivalent refraction [ Time Frame: 1 month ]
  • Residual mean spherical equivalent refraction [ Time Frame: 3 months ]
  • Residual refractive sphere [ Time Frame: 1 month ]
  • Residual refractive sphere [ Time Frame: 3 months ]
  • Residual refractive cylinder [ Time Frame: 1 month ]
  • Residual refractive cylinder [ Time Frame: 3 months ]
  • Percentage of eyes with postoperative manifest refraction spherical equivalent (MRSE) accuracy to target ≤ 0.5D [ Time Frame: 1 month ]
  • Percentage of eyes with postoperative MRSE accuracy to target ≤ 0.5D [ Time Frame: 3 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Symfony Toric Intraocular Lens Visual Outcomes
Official Title  ICMJE Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
Brief Summary In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract Bilateral
  • Astigmatism Bilateral
Intervention  ICMJE Device: Presbyopia and astigmatism correcting intraocular lens
The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
Study Arms  ICMJE
  • Active Comparator: Emmetropia both eyes (OU) group
    Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
    Intervention: Device: Presbyopia and astigmatism correcting intraocular lens
  • Experimental: Nanovision group
    Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
    Intervention: Device: Presbyopia and astigmatism correcting intraocular lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 3, 2018
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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.
  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 the zonules.
  10. Previous intraocular surgery.
  11. Previous refractive surgery.
  12. Previous keratoplasty
  13. Severe dry eye
  14. Pupil abnormalities
  15. 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)
  16. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
  17. 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.
  18. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03082599
Other Study ID Numbers  ICMJE CEP 2016-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carolina Eyecare Physicians, LLC
Study Sponsor  ICMJE Carolina Eyecare Physicians, LLC
Collaborators  ICMJE
  • Science in Vision
  • Abbott Medical Optics
Investigators  ICMJE
Study Chair: Kerry D. Solomon, MD Carolina Eyecare Physicians, LLC
PRS Account Carolina Eyecare Physicians, LLC
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP