Trial Outcomes & Findings for Symfony/Synergy IOL Combination Outcomes (NCT NCT05604781)

NCT ID: NCT05604781

Last Updated: 2024-03-18

Results Overview

Recruitment status

COMPLETED

Target enrollment

41 participants

Primary outcome timeframe

3 months

Results posted on

2024-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Symfony & Synergy IOL Combination Symfony \& Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Overall Study STARTED	41
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Symfony & Synergy IOL Combination Symfony \& Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	1

Baseline Characteristics

Symfony/Synergy IOL Combination Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symfony & Synergy IOL Combination n=37 Participants Symfony \& Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Age, Continuous	68.6 years STANDARD_DEVIATION 6.3 • n=39 Participants
Sex: Female, Male Female	27 Participants n=39 Participants
Sex: Female, Male Male	10 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	37 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	37 participants n=39 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Symfony & Synergy IOL Combination n=37 Participants Symfony \& Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Binocular Defocus Curve +1.00 D	0.07 logMAR Standard Deviation 0.10
Binocular Defocus Curve +0.50 D	-0.05 logMAR Standard Deviation 0.08
Binocular Defocus Curve 0.00 D	-0.08 logMAR Standard Deviation 0.12
Binocular Defocus Curve -0.50 D	-0.05 logMAR Standard Deviation 0.09
Binocular Defocus Curve -1.00 D	-0.04 logMAR Standard Deviation 0.10
Binocular Defocus Curve -1.50 D	-0.03 logMAR Standard Deviation 0.13
Binocular Defocus Curve -2.00 D	0.04 logMAR Standard Deviation 0.13
Binocular Defocus Curve -2.50 D	0.07 logMAR Standard Deviation 0.14
Binocular Defocus Curve -3.00 D	0.14 logMAR Standard Deviation 0.14

SECONDARY outcome

Timeframe: 3 months

Percentage for participants who are completely or mostly satisfied with their overall vision will be assessed

Outcome measures

Outcome measures
Measure	Symfony & Synergy IOL Combination n=37 Participants Symfony \& Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Patient Satisfaction Questionnaire	31 Participants

SECONDARY outcome

Timeframe: 3 months

Percentage of participants reporting the need to wear glasses all the time for near activities will be assessed.

Outcome measures

Outcome measures
Measure	Symfony & Synergy IOL Combination n=37 Participants Symfony \& Synergy IOL combination: The Symfony IOL will be implanted in the dominant eye while the Synergy IOL will be implanted in the non-dominant eye.
Spectacle Independence for Near Activities Questionnaire	4 Participants

Adverse Events

Symfony & Synergy IOL Combination

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 Clinical Research

Center For Sight

Phone: 8438813937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place