Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03771274 |
Recruitment Status :
Completed
First Posted : December 11, 2018
Results First Posted : August 10, 2020
Last Update Posted : August 10, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cataract Bilateral Presbyopia | Device: Tecnis ZLB00 & Symfony IOL | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | October 31, 2019 |
Actual Study Completion Date : | October 31, 2019 |
Arm | Intervention/treatment |
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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.
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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. |
- Binocular Uncorrected Near (40 cm) Visual Acuity. [ Time Frame: 3 months ]Visual acuity measured at 40 cm without wearing any correction.
- 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.
- 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.
- 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.

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

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
United States, South Carolina | |
Carolina Eyecare Physicians, LLC | |
Mount Pleasant, South Carolina, United States, 29464 |
Documents provided by Carolina Eyecare Physicians, LLC:
Responsible Party: | Carolina Eyecare Physicians, LLC |
ClinicalTrials.gov Identifier: | NCT03771274 |
Other Study ID Numbers: |
CEP18-002 |
First Posted: | December 11, 2018 Key Record Dates |
Results First Posted: | August 10, 2020 |
Last Update Posted: | August 10, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Cataract Presbyopia Lens Diseases Eye Diseases Refractive Errors |