Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes
|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 : Active, not recruiting
First Posted : December 11, 2018
Last Update Posted : August 12, 2019
|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|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 31, 2020|
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 distance-corrected near (40 cm) visual acuity. [ Time Frame: 1 month ]Visual acuity measured at 40 cm using the distance-correction if needed.
- Binocular distance-corrected near (40 cm) visual acuity. [ Time Frame: 3 months ]Visual acuity measured at 40 cm using the distance-correction if needed.
- 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". Possible answers are: Completely satisfied, mostly satisfied, moderately satisfied, a little satisfied, not at all satisfied.
- Spectacle independence: questionnaire [ Time Frame: 3 months ]Patient's spectacle independence will be 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. Possible answers: Yes No. 2. During the LAST 7 DAYS, how often did you wear glasses or contacts and 3. During the LAST 7 DAYS, were you able to function comfortably WITHOUT glasses or contacts. Questions 2 and 3 possible answers are: All of the time, Most of the time, Some of the time, A little of the time, None of the time
- Visual symptoms [ Time Frame: 3 months ]Patient's reported visual symptoms
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|