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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Cylinder IOL | Experimental | Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECNIS Toric Models ZCT450, ZCT525 or ZCT600 | Device | Approved toric intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Severe Visual Distortions | Rate of severe visual distortions based on data from a self administered subject questionnaire | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of IOL Repositioning Due to IOL Misalignment | Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL | 6 months |
| Percent Change in Cylinder | Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devi Priya Janakiraman, OD,FAAO | Abbott Medical Optics | Study Director |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Cylinder IOL | All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects with an extended (high) cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye.Per the statistical plan, data for the ZCT450,ZCT525 and ZCT600 toric IOLs were to be pooled together and reported as one group.
| ID | Title | Description |
|---|---|---|
| BG000 | Extended Cylinder IOL | All subjects implanted with an extended cylinder IOL (ZCT450, ZCT525 or ZCT600) in at least one eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Severe Visual Distortions | Rate of severe visual distortions based on data from a self administered subject questionnaire | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Cylinder IOL | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lens misalignment requiring IOL repositioning | Surgical and medical procedures | Systematic Assessment | 6 participants (6 events) with ZCT600, 4 participants (5 events) with ZCT450 and 1 participant (1 event) with ZCT400 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iridocyclitis | Eye disorders | Systematic Assessment | 1 participant implanted with ZCT450 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devi Priya Janakiraman, OD, FAAO | Johnson & Johnson Surgical Vision | 1+ 714-247-8429 | djanaki1@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | Aug 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2015 | Aug 20, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| 6 months |
| Primary Eyes |
|
| Years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
|
|
| Other Pre-specified | Rate of IOL Repositioning Due to IOL Misalignment | Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL | All subjects implanted with a ZCT450/525/600 in at least one eye | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Percent Change in Cylinder | Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100 | All subjects implanted with a ZCT450/525/600 in at least one eye | Posted | Mean | Standard Deviation | Percent change | 6 months |
|
|
|
| 0 |
| 101 |
| 19 |
| 101 |
| 1 |
| 101 |
|
| Hyphema | Eye disorders | Systematic Assessment | 1 participant implanted with ZCT400 |
|
| Cystoid Macular Edema | Eye disorders | Systematic Assessment | 1 participant implanted with ZCT525 |
|
| Hospitalization due to fall and broken hip | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Squamous Cell Carcinoma - Left second finger | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hospitalization due to unsteady gait/dizziness | General disorders | Systematic Assessment |
|
| Hospitalization due to appendectomy due to appendicitis | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization due to motorcycle accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lens exchange due to residual astigmatism and myopia | Surgical and medical procedures | Systematic Assessment | 1 participant implanted with ZCT525 |
|
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.