Trial Outcomes & Findings for Post-Approval Study of the Tecnis® Toric IOL (NCT NCT02566083)

Last Updated: 2020-01-18

Results Overview

The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.

Recruitment status

COMPLETED

Study phase

Target enrollment

365 participants

Primary outcome timeframe

6 months

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Toric IOL Experimental (ZCT300, ZCT400)	Non-toric IOL Control (ZCB00)
Overall Study STARTED	214	151
Overall Study COMPLETED	198	141
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Approval Study of the Tecnis® Toric IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toric IOL n=214 Participants Experimental (ZCT300, ZCT400)	Non-toric IOL n=151 Participants Control (ZCB00)	Total n=365 Participants Total of all reporting groups
Age, Continuous	69.3 Years STANDARD_DEVIATION 9.6 • n=5 Participants	69.7 Years STANDARD_DEVIATION 10.0 • n=7 Participants	69.5 Years STANDARD_DEVIATION 9.75 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	82 Participants n=7 Participants	202 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	69 Participants n=7 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants	141 Participants n=7 Participants	336 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	197 Participants n=5 Participants	128 Participants n=7 Participants	325 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All subjects bilaterally implanted with a toric IOL (ZCT300 or ZCT400) and all subjects bilaterally implanted with a control IOL (ZCB00). All subjects who were monocularly implanted with a toric IOL (ZCT300/400) or control were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Toric IOL n=189 Participants Experimental (ZCT300, ZCT400)	Non-toric IOL n=144 Participants Control (ZCB00)
Rate of Severe Visual Distortions With severe visual distortion	0 Participants	2 Participants
Rate of Severe Visual Distortions With No severe visual distortion	189 Participants	142 Participants

Adverse Events

Toric IOL

Serious events: 32 serious events

Other events: 0 other events

Deaths: 1 deaths

Non-toric IOL

Serious events: 16 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Toric IOL n=214 participants at risk Experimental (ZCT300, ZCT400)	Non-toric IOL n=151 participants at risk Control (ZCB00)
Eye disorders Cystoid Macular Edema	0.00% 0/214 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.66% 1/151 • Number of events 2 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.

Additional Information

Devi Priya Janakiraman, OD, FAAO

Johnson & Johnson Surgical Vision

Phone: +1 714 247- 8628

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

Measure	Toric IOL n=214 participants at risk Experimental (ZCT300, ZCT400)	Non-toric IOL n=151 participants at risk Control (ZCB00)
Surgical and medical procedures Lens repositioning	5.6% 12/214 • Number of events 12 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Epiretinal membrane with significant Vitreo-Retinal traction	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Cystoid Macular Edema	2.8% 6/214 • Number of events 8 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	3.3% 5/151 • Number of events 5 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Macular Hole	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Clinically Significant Macular Edema	0.00% 0/214 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.66% 1/151 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Surgical and medical procedures Residual Cortical material	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.66% 1/151 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Elevated intraocular pressure requiring treatment	0.93% 2/214 • Number of events 2 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Capsular Rupture	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Retinal Detachment	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Hyphema	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Macular Edema	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Capsular Tear	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Eye disorders Vitreous Strand	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
General disorders Hospitalization	0.93% 2/214 • Number of events 2 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	5.3% 8/151 • Number of events 9 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.93% 2/214 • Number of events 2 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
General disorders Death	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	1.3% 2/151 • Number of events 2 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Vascular disorders Crerebrovascular Accident	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.
Gastrointestinal disorders Ulcerative Colitis	0.47% 1/214 • Number of events 1 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.	0.00% 0/151 • All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year postoperative.