Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract Bilateral, Presbyopia

Intervention / Treatment
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* Device: Tecnis ZLB00 & Symfony IOL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tecnis ZLB00 & Symfony IOL<br>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<br>* The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Uncorrected Near (40 cm) Visual Acuity. | Visual acuity measured at 40 cm without wearing any correction. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Visual Satisfaction After Cataract Surgery: Questionnaire | 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. | 3 months | 
| Spectacle Independence: Questionnaire | 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 months | 
| Number of Participants With Visual Symptoms | Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom. | 3 months |