Trial Outcomes & Findings for Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes (NCT NCT03771274)

NCT ID: NCT03771274

Last Updated: 2020-08-10

Results Overview

Visual acuity measured at 40 cm without wearing any correction.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-08-10

Participant Flow

Participant milestones

Measure	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. 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.
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Baseline characteristics by cohort

Measure	Tecnis ZLB00 & Symfony IOL n=39 Participants 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. 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.
Age, Continuous	65.7 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Visual acuity measured at 40 cm without wearing any correction.

Outcome measures

Measure

Tecnis ZLB00 & Symfony IOL n=39 Participants 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. 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.

0.13 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tecnis ZLB00 & Symfony IOL n=39 Participants 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. 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.
Patient Visual Satisfaction After Cataract Surgery: Questionnaire Completely or mostly satisfied	27 Participants
Patient Visual Satisfaction After Cataract Surgery: Questionnaire Moderately satisfied	5 Participants
Patient Visual Satisfaction After Cataract Surgery: Questionnaire A little or not satisfied	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tecnis ZLB00 & Symfony IOL n=39 Participants 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. 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.
Spectacle Independence: Questionnaire Yes	12 Participants
Spectacle Independence: Questionnaire No	27 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participants who reported any visual disturbances or symptoms. One participant could report more than one symptom.

Outcome measures

Measure	Tecnis ZLB00 & Symfony IOL n=39 Participants 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. 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.
Number of Participants With Visual Symptoms Halos : Yes	25 Participants
Number of Participants With Visual Symptoms Halos : No	14 Participants
Number of Participants With Visual Symptoms Sensitivity to light: Yes	23 Participants
Number of Participants With Visual Symptoms Sensitivity to light: No	16 Participants

Adverse Events

Tecnis ZLB00 & Symfony IOL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

Carolina Eyecare Physicians, LLC

Phone: 8438813937

Email: helga.sandoval@carolinaeyecare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place