Trial Outcomes & Findings for Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL) (NCT NCT02649842)

NCT ID: NCT02649842

Last Updated: 2025-02-04

Results Overview

Rate of severe visual distortions based on data from a self administered subject questionnaire

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-04

Participant Flow

Per SAP there is only one arm. It includes all subjects with ZCT450/525/600 toric IOL in the primary eye.Fellow eye can have the same IOL or a ZCT300/400.

Participant milestones

Participant milestones
Measure	Extended Cylinder IOL All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Cylinder IOL n=101 Primary Eyes All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Age, Continuous	65.5 Years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	1 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All subjects implanted with a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) in at least one eye and a high cylinder or low cylinder toric IOL in the fellow eye.

Rate of severe visual distortions based on data from a self administered subject questionnaire

Outcome measures

Outcome measures
Measure	Extended Cylinder IOL n=100 Participants All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Rate of Severe Visual Distortions	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All subjects implanted with a ZCT450/525/600 in at least one eye

Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL

Outcome measures

Outcome measures
Measure	Extended Cylinder IOL n=101 Participants All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Rate of IOL Repositioning Due to IOL Misalignment	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: All subjects implanted with a ZCT450/525/600 in at least one eye

Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))\*100

Outcome measures

Outcome measures
Measure	Extended Cylinder IOL n=101 Participants All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.
Percent Change in Cylinder	88.36 Percent change Standard Deviation 21.09

Adverse Events

Extended Cylinder IOL

Serious events: 19 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Extended Cylinder IOL n=101 participants at risk All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. Subject is considered to have adverse events whether the adverse event was in the higher cylinder or lower cylinder group.
Surgical and medical procedures Lens misalignment requiring IOL repositioning	10.9% 11/101 • Number of events 12 • 6 months
Eye disorders Hyphema	0.99% 1/101 • Number of events 1 • 6 months
Eye disorders Cystoid Macular Edema	0.99% 1/101 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Hospitalization due to fall and broken hip	0.99% 1/101 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Squamous Cell Carcinoma - Left second finger	0.99% 1/101 • Number of events 1 • 6 months
General disorders Hospitalization due to unsteady gait/dizziness	0.99% 1/101 • Number of events 1 • 6 months
Surgical and medical procedures Hospitalization due to appendectomy due to appendicitis	0.99% 1/101 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Hospitalization due to motorcycle accident	0.99% 1/101 • Number of events 1 • 6 months
Surgical and medical procedures Lens exchange due to residual astigmatism and myopia	0.99% 1/101 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Extended Cylinder IOL n=101 participants at risk All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. Subject is considered to have adverse events whether the adverse event was in the higher cylinder or lower cylinder group.
Eye disorders Iridocyclitis	0.99% 1/101 • Number of events 1 • 6 months

Additional Information

Devi Priya Janakiraman, OD, FAAO

Johnson & Johnson Surgical Vision

Phone: 1+ 714-247-8429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.
Publication restrictions are in place

Restriction type: OTHER