Post-Approval Study of the Tecnis® Toric IOL

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02566083
• Collaborator: (none)
• Enrollment: 365
• Locations: 44
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: non-toric intraocular lens; Device: toric intraocular lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 365 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
• Actual Study Start Date: Oct 21, 2015
• Actual Primary Completion Date: Dec 11, 2018
• Actual Study Completion Date: May 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: non-toric intraocular lens non-toric approved intraocular lens	Device: non-toric intraocular lens; TECNIS One-piece Monofocal Model ZCB00
Active Comparator: toric intraocular lens approved toric intraocular lens	Device: toric intraocular lens; TECNIS One-piece Toric Models ZCT300 or ZCT400

Outcome Measures

Primary Outcome Measures

1. Rate of Severe Visual Distortions [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Minimum 22 years of age

• Bilateral cataracts

• Preoperative keratometric cylinder in both eyes

• Most appropriate toric IOL model choice (ZCT300 or ZCT400)

• Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:

≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL

• Clear intraocular media other than cataract in each eye

• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits

• Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire

• Signed informed consent and HIPAA authorization

Exclusion Criteria:

• Irregular corneal astigmatism

• Any corneal pathology/abnormality other than regular corneal astigmatism

• Previous corneal surgery

• Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes

• Any pupil abnormalities

• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects

• Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study

• Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study

• Planned monovision correction

• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Center South	Dothan	Alabama	United States	36301
2	Arizona Eye Cente	Chandler	Arizona	United States	85225
3	Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente	Tucson	Arizona	United States	85704
4	Boozman-Hof Regional Eye Clinic	Rogers	Arkansas	United States	72757
5	Empire Eye & Laser Center	Bakersfield	California	United States	93309
6	Atlantis Eye Care	Huntington Beach	California	United States	92647
7	Scripps Clinic Medical Group	La Jolla	California	United States	92037
8	Southern California Eye Physicians & Associates	Long Beach	California	United States	90805
9	Feinerman Vision Center	Newport Beach	California	United States	92663
10	Coastal Vision	Orange	California	United States	92868
11	California Eye Medical Specialists	Pasadena	California	United States	91107
12	Wolstan & Goldberg Eye Associates	Torrance	California	United States	90505
13	Florida Eye Microsurgical Institute, Inc.	Boynton Beach	Florida	United States	33426
14	Katzen Eye Care & Laser Center	Boynton Beach	Florida	United States	33426
15	The Eye Associates	Bradenton	Florida	United States	34209
16	Cape Coral Eye Center	Cape Coral	Florida	United States	336904
17	Levenson Eye Associates, Inc.	Jacksonville	Florida	United States	32204
18	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
19	Virdi Eye Clinic & Laser Vision Center	Rock Island	Illinois	United States	61201
20	Senior Health Services	Louisville	Kentucky	United States	40220
21	Chesapeake Eye Care and Laser Center	Annapolis	Maryland	United States	21401
22	Solomon Eye Associates	Bowie	Maryland	United States	20716
23	Eye Doctors of Washington	Chevy Chase	Maryland	United States	20815
24	Oakland Ophthalmic Surgery, P.C.	Birmingham	Michigan	United States	48009
25	TLC Eye Care and Laser Centers	Chelsea	Michigan	United States	48118
26	Ophthalmology Associates	Saint Louis	Missouri	United States	63131
27	Ophthalmology Consultants	Saint Louis	Missouri	United States	63131
28	Mercy Clinic Eye Specialist	Springfield	Missouri	United States	65804
29	Kindermann Eye Associates	Cherry Hill	New Jersey	United States	08002
30	Matossian Eye Associates	Pennington	New Jersey	United States	08534
31	Eye Associates of New Mexico	Albuquerque	New Mexico	United States	87109
32	Pamel Vision & Laser Group	New York	New York	United States	10065
33	Fine, Hoffman & Sims	Eugene	Oregon	United States	97401
34	The Eye Center of Central PA	Allenwood	Pennsylvania	United States	17810
35	Ludwick Eye Center	Chambersburg	Pennsylvania	United States	17201
36	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania	United States	16066
37	Carolina Cataract & Laser Center	Ladson	South Carolina	United States	29456
38	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57105
39	Loden Vision Centers	Goodlettsville	Tennessee	United States	37072
40	Houston Eye Associates	Houston	Texas	United States	77025
41	Whitsett Vision Group	Houston	Texas	United States	77055
42	Focal Point Vision	San Antonio	Texas	United States	78229
43	San Antonio Eye Specialists	San Antonio	Texas	United States	78248
44	Clarus Eye Centre	Lacey	Washington	United States	98503

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

• Study Protocol - May 21, 2018
• Statistical Analysis Plan - Jun 24, 2015

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT02566083
• Other Study ID Numbers: TIOL-202-TPAS
• First Posted: Oct 1, 2015
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Toric IOL	Non-toric IOL
Arm/Group Description	Experimental (ZCT300, ZCT400)	Control (ZCB00)
Period Title: Overall Study
STARTED	214	151
COMPLETED	198	141
NOT COMPLETED	16	10

Baseline Characteristics

Arm/Group Title	Toric IOL	Non-toric IOL	Total
Arm/Group Description	Experimental (ZCT300, ZCT400)	Control (ZCB00)	Total of all reporting groups
Overall Participants	214	151	365
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	69.3 (9.6)	69.7 (10.0)	69.5 (9.75)
Sex: Female, Male (Count of Participants)
Female	120 56.1%	82 54.3%	202 55.3%
Male	94 43.9%	69 45.7%	163 44.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	19 8.9%	10 6.6%	29 7.9%
Not Hispanic or Latino	195 91.1%	141 93.4%	336 92.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.7%	1 0.3%
Asian	6 2.8%	4 2.6%	10 2.7%
Native Hawaiian or Other Pacific Islander	1 0.5%	0 0%	1 0.3%
Black or African American	10 4.7%	18 11.9%	28 7.7%
White	197 92.1%	128 84.8%	325 89%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Rate of Severe Visual Distortions
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Toric IOL	Non-toric IOL
Arm/Group Description	Experimental (ZCT300, ZCT400)	Control (ZCB00)
Measure Participants	189	144
With No severe visual distortion	189 88.3%	142 94%
With severe visual distortion	0 0%	2 1.3%

Adverse Events

Time Frame	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.
Arm/Group Title	Toric IOL		Non-toric IOL
Arm/Group Description	Experimental (ZCT300, ZCT400)		Control (ZCB00)
All Cause Mortality
	Toric IOL		Non-toric IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/214 (0.5%)		2/151 (1.3%)
Serious Adverse Events
	Toric IOL		Non-toric IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/214 (15%)		16/151 (10.6%)
Eye disorders
Epiretinal membrane with significant Vitreo-Retinal traction	1/214 (0.5%)	1	0/151 (0%)	0
Cystoid Macular Edema	6/214 (2.8%)	8	5/151 (3.3%)	5
Macular Hole	1/214 (0.5%)	1	0/151 (0%)	0
Clinically Significant Macular Edema	0/214 (0%)	0	1/151 (0.7%)	1
Elevated intraocular pressure requiring treatment	2/214 (0.9%)	2	0/151 (0%)	0
Capsular Rupture	1/214 (0.5%)	1	0/151 (0%)	0
Retinal Detachment	1/214 (0.5%)	1	0/151 (0%)	0
Hyphema	1/214 (0.5%)	1	0/151 (0%)	0
Macular Edema	1/214 (0.5%)	1	0/151 (0%)	0
Capsular Tear	1/214 (0.5%)	1	0/151 (0%)	0
Vitreous Strand	1/214 (0.5%)	1	0/151 (0%)	0
Gastrointestinal disorders
Ulcerative Colitis	1/214 (0.5%)	1	0/151 (0%)	0
General disorders
Hospitalization	2/214 (0.9%)	2	8/151 (5.3%)	9
Death	1/214 (0.5%)	1	2/151 (1.3%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer	1/214 (0.5%)	1	0/151 (0%)	0
Breast Cancer	2/214 (0.9%)	2	0/151 (0%)	0
Surgical and medical procedures
Lens repositioning	12/214 (5.6%)	12	0/151 (0%)	0
Residual Cortical material	1/214 (0.5%)	1	1/151 (0.7%)	1
Vascular disorders
Crerebrovascular Accident	1/214 (0.5%)	1	0/151 (0%)	0
Other (Not Including Serious) Adverse Events
	Toric IOL		Non-toric IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/214 (0%)		1/151 (0.7%)
Eye disorders
Cystoid Macular Edema	0/214 (0%)	0	1/151 (0.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.