Trial Outcomes & Findings for Synergy Lens Outcomes Evaluation (NCT NCT05418153)

Last Updated: 2024-03-18

Results Overview

Visual acuity measured at 40 cm

Recruitment status

COMPLETED

Target enrollment

52 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2024-03-18

Participant milestones
Measure	Synergy IOL Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Synergy Lens Outcomes Evaluation

Baseline characteristics by cohort
Measure	Synergy IOL n=52 Participants Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants

Timeframe: Up to 1 year

Visual acuity measured at 40 cm

Outcome measures
Measure	Synergy IOL n=52 Participants Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions	0.01 logMAR Standard Deviation 0.07

Timeframe: Up to 1 year

Visual acuity measured at 40 cm under dim light

Outcome measures
Measure	Synergy IOL n=35 Participants Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions	0.21 logMAR Standard Deviation 0.12

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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