Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes
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|ClinicalTrials.gov Identifier: NCT03771274|
Recruitment Status : Completed
First Posted : December 11, 2018
Results First Posted : August 10, 2020
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cataract Bilateral Presbyopia||Device: Tecnis ZLB00 & Symfony IOL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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|