Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
Study Details
Study Description
Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye.
Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group.
The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye.
There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye.
Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Extended Cylinder IOL Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600 |
Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens
|
Outcome Measures
Primary Outcome Measures
- Rate of Severe Visual Distortions [6 months]
Rate of severe visual distortions based on data from a self administered subject questionnaire
Other Outcome Measures
- Rate of IOL Repositioning Due to IOL Misalignment [6 months]
Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
- Percent Change in Cylinder [6 months]
Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Minimum 22 years of age
-
Bilateral cataracts
-
Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.
-
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 or 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
-
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 or is lactating
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye Center South | Dothan | Alabama | United States | 36301 |
| 2 | Arizona Eye Center | Chandler | Arizona | United States | 85225 |
| 3 | Fishkind, Bakewell & Maltzman Eye Care & Surgery Center | Tucson | Arizona | United States | 85704 |
| 4 | Scripps Clinical Medical Group | La Jolla | California | United States | 92037 |
| 5 | Southern California Eye Physicians & Associates | Long Beach | California | United States | 90805 |
| 6 | Katzen Eye Care & Laser Center | Boynton Beach | Florida | United States | 33426 |
| 7 | Levenson Eye Associates, Inc. | Jacksonville | Florida | United States | 32204 |
| 8 | Virdi Eye Clinic & Laser Vision Center | Rock Island | Illinois | United States | 61201 |
| 9 | Senior Health Services | Louisville | Kentucky | United States | 40220 |
| 10 | Chesapeake Eye Care and Laser Center | Annapolis | Maryland | United States | 21401 |
| 11 | Eye Doctors of Washington | Chevy Chase | Maryland | United States | 20815 |
| 12 | Mercy Research | Springfield | Missouri | United States | 65804 |
| 13 | Kindermann Eye Associates | Cherry Hill | New Jersey | United States | 08002 |
| 14 | Eye Associates of New Mexico | Albuquerque | New Mexico | United States | 87109 |
| 15 | Pamel Vision & Laser Group | New York | New York | United States | 10065 |
| 16 | Carolina Cataract & Laser Center | Ladson | South Carolina | United States | 29456 |
| 17 | Carolina Eyecare Physicians, LLC | Pleasant | South Carolina | United States | 29464 |
| 18 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57108 |
| 19 | Texas Eye and Laser Center | Hurst | Texas | United States | 76054 |
| 20 | Clarus Eye Centre | Lacey | Washington | United States | 98503 |
Sponsors and Collaborators
- Abbott Medical Optics
Investigators
- Study Director: Devi Priya Janakiraman, OD,FAAO, Abbott Medical Optics
Study Documents (Full-Text)
More Information
Publications
None provided.- TIOL-204-EPAS
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Extended Cylinder IOL |
|---|---|
| Arm/Group Description | All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. |
| Period Title: Overall Study | |
| STARTED | 101 |
| COMPLETED | 101 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Extended Cylinder IOL |
|---|---|
| Arm/Group Description | All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. |
| Overall Participants | 101 |
| Overall Primary Eyes | 101 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
65.5
(12.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
50
49.5%
|
| Male |
51
50.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
1%
|
| White |
94
93.1%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
3%
|
Outcome Measures
| Title | Rate of Severe Visual Distortions |
|---|---|
| Description | Rate of severe visual distortions based on data from a self administered subject questionnaire |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Extended Cylinder IOL |
|---|---|
| Arm/Group Description | All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. |
| Measure Participants | 100 |
| Count of Participants [Participants] |
3
3%
|
| Title | Rate of IOL Repositioning Due to IOL Misalignment |
|---|---|
| Description | Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects implanted with a ZCT450/525/600 in at least one eye |
| Arm/Group Title | Extended Cylinder IOL |
|---|---|
| Arm/Group Description | All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) |
| Measure Participants | 101 |
| Count of Participants [Participants] |
11
10.9%
|
| Title | Percent Change in Cylinder |
|---|---|
| Description | Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100 |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects implanted with a ZCT450/525/600 in at least one eye |
| Arm/Group Title | Extended Cylinder IOL |
|---|---|
| Arm/Group Description | All subjects implanted with a ZCT450/525/600 in at least one eye |
| Measure Participants | 101 |
| Mean (Standard Deviation) [Percent change] |
88.36
(21.09)
|
Adverse Events
| Time Frame | 6 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Extended Cylinder IOL | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Extended Cylinder IOL | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/101 (0%) | |
Serious Adverse Events |
||
| Extended Cylinder IOL | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/101 (18.8%) | |
| Eye disorders | ||
| Hyphema | 1/101 (1%) | 1 |
| Cystoid Macular Edema | 1/101 (1%) | 1 |
| General disorders | ||
| Hospitalization due to unsteady gait/dizziness | 1/101 (1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Hospitalization due to fall and broken hip | 1/101 (1%) | 1 |
| Hospitalization due to motorcycle accident | 1/101 (1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Squamous Cell Carcinoma - Left second finger | 1/101 (1%) | 1 |
| Surgical and medical procedures | ||
| Lens misalignment requiring IOL repositioning | 11/101 (10.9%) | 12 |
| Hospitalization due to appendectomy due to appendicitis | 1/101 (1%) | 1 |
| Lens exchange due to residual astigmatism and myopia | 1/101 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Extended Cylinder IOL | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/101 (1%) | |
| Eye disorders | ||
| Iridocyclitis | 1/101 (1%) | 1 |
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Devi Priya Janakiraman, OD, FAAO |
|---|---|
| Organization | Johnson & Johnson Surgical Vision |
| Phone | 1+ 714-247-8429 |
| djanaki1@its.jnj.com |
- TIOL-204-EPAS