Trial Outcomes & Findings for A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens. (NCT NCT05396599)

NCT ID: NCT05396599

Last Updated: 2024-06-04

Results Overview

The percentage of eyes with rotational stability of the IOL at postoperative 1 month.

Recruitment status

TERMINATED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

1 month

Results posted on

2024-06-04

Participant Flow

A total of 37 subjects were consented. Out of 37 subjects, 2 subjects were screen failures and 35 subjects were enrolled and completed the study. Out of 35 subjects, 11 subjects were treated with Test Lens 1 (TECNIS Eyhance Toric II IOL), 13 subjects were treated with Test Lens 2 (TECNIS Synergy Toric II IOL), and 11 subjects were treated with control lens (TECNIS Toric 1-Piece IOL).

Participant milestones

Participant milestones
Measure	Test Lens 1 TECNIS Eyhance Toric II IOL	Test Lens 2 TECNIS Synergy Toric II IOL	Control Lens TECNIS Toric 1-Piece IOL
Overall Study STARTED	11	13	11
Overall Study COMPLETED	11	13	11
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Lens 1 n=19 Eye TECNIS Eyhance Toric II IOL	Test Lens 2 n=22 Eye TECNIS Synergy Toric II IOL	Control Lens n=17 Eye TECNIS Toric 1-Piece IOL	Total n=58 Eye Total of all reporting groups
Age, Customized <60	2 Years n=5 Participants	2 Years n=7 Participants	0 Years n=5 Participants	4 Years n=4 Participants
Age, Customized 60-69	2 Years n=5 Participants	7 Years n=7 Participants	3 Years n=5 Participants	12 Years n=4 Participants
Age, Customized 70-79	5 Years n=5 Participants	3 Years n=7 Participants	7 Years n=5 Participants	15 Years n=4 Participants
Age, Customized >=80	2 Years n=5 Participants	1 Years n=7 Participants	1 Years n=5 Participants	4 Years n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month

Population: All eyes with available data at 1 month visit.

The percentage of eyes with rotational stability of the IOL at postoperative 1 month.

Outcome measures

Outcome measures
Measure	Test Lens 1 n=19 Eyes TECNIS Eyhance Toric II IOL	Test Lens 2 n=22 Eyes TECNIS Synergy Toric II IOL	Control Lens n=16 Eyes TECNIS Toric 1-Piece IOL
Rotational Stability of IOL	19 Eyes	22 Eyes	16 Eyes

Adverse Events

Test Lens 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Lens 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Lens

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

Luis Vargas, MD

Johnson & Johnson Surgical Vision

Phone: 714-247-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER