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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

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.

Condition or disease Intervention/treatment Phase
Cataract Bilateral Astigmatism Bilateral Device: Presbyopia and astigmatism correcting intraocular lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : April 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Emmetropia both eyes (OU) group
Symfony Toric IOL target refraction both eyes emmetropia (±0.25D).
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.

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.
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.




Primary Outcome Measures :
  1. Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 1 months ]
  2. Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 3 months ]
  3. Reduction of manifest cylinder (diopters). [ Time Frame: 1 month ]
  4. Reduction of manifest cylinder (diopters). [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Uncorrected and distance-corrected near (40 cm) visual acuity [ Time Frame: 1 month ]
  2. Uncorrected and distance-corrected near (40 cm) visual acuity [ Time Frame: 3 months ]
  3. Uncorrected and distance-corrected intermediate (66 cm) visual acuity [ Time Frame: 1 month ]
  4. Uncorrected and distance-corrected intermediate (66 cm) visual acuity [ Time Frame: 3 months ]
  5. Uncorrected and best-corrected distance (4 m) visual acuity [ Time Frame: 1 month ]
  6. Uncorrected and best-corrected distance (4 m) visual acuity [ Time Frame: 3 months ]
  7. Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [ Time Frame: 1 month ]
  8. Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) [ Time Frame: 3 months ]
  9. Patient Reported Spectacle Independence Questionnaire [ Time Frame: 1 month ]
  10. Patient Reported Spectacle Independence Questionnaire [ Time Frame: 3 months ]
  11. 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


Other Outcome Measures:
  1. Residual mean spherical equivalent refraction [ Time Frame: 1 month ]
  2. Residual mean spherical equivalent refraction [ Time Frame: 3 months ]
  3. Residual refractive sphere [ Time Frame: 1 month ]
  4. Residual refractive sphere [ Time Frame: 3 months ]
  5. Residual refractive cylinder [ Time Frame: 1 month ]
  6. Residual refractive cylinder [ Time Frame: 3 months ]
  7. Percentage of eyes with postoperative manifest refraction spherical equivalent (MRSE) accuracy to target ≤ 0.5D [ Time Frame: 1 month ]
  8. Percentage of eyes with postoperative MRSE accuracy to target ≤ 0.5D [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (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. 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.

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): NCT03082599


Locations
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United States, Minnesota
Associated Eye Care
Stillwater, Minnesota, United States, 55082
United States, New York
Ophthalmic Consultants of Long Island
Garden City, New York, United States, 11530
United States, South Carolina
Carolina Eyecare Physicians, LLC
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Slade & Baker Vision Center
Houston, Texas, United States, 77027
Sponsors and Collaborators
Carolina Eyecare Physicians, LLC
Science in Vision
Abbott Medical Optics
Investigators
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Study Chair: Kerry D. Solomon, MD Carolina Eyecare Physicians, LLC

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Responsible Party: Carolina Eyecare Physicians, LLC
ClinicalTrials.gov Identifier: NCT03082599     History of Changes
Other Study ID Numbers: CEP 2016-002
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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