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The aims of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control IOL | Active Comparator | Approved Intraocular control lens |
|
| Toric IOL | Experimental | Investigational Toric IOL |
|
| Higher Cylinder Toric IOL | Experimental | Investigational Toric IOLs with higher cylinder powers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecnis ZCB00 IOL (control) | Device | Tecnis 1-piece acrylic IOL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Reduction in Cylinder | Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean. | 6 months after second eye implant compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) | Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Tarantino, O.D. | Abbott Medical Optics | Study Director |
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Subjects with low cylinder were enrolled in a randomized group and received either the control lens or the investigational Toric IOL. Subjects with higher cylinder were enrolled in the high cylinder group and received a higher cylinder investigational Toric IOL.
Subjects were enrolled from normal cataract populations at 14 investigative sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZCB00 | Approved Intraocular control lens |
| FG001 | Toric IOL | Investigational Toric IOL |
| FG002 | Higher Cylinder Toric IOL | Investigational toric IOLs with higher cylinder powers. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZCB00 | Approved Intraocular control lens |
| BG001 | Toric IOL | Investigational Toric IOL |
| 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 | Mean Percent Reduction in Cylinder | Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean. | Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder. | Posted | Mean | Standard Deviation | percentage of reduction in cylinder | 6 months after second eye implant compared to baseline |
|
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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 | ZCB00 | Approved Intraocular control lens |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lens Repositioning Procedure | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Featherstone | Abbott Medical Optics | 714-247-8621 | kristen.featherstone@amo.abbott.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Toric Intraocular lens |
| Device |
Toric acrylic intraocular lens with various cylinder powers |
|
| 6 months after second eye implant |
| BG002 |
| Higher Cylinder Toric IOL |
Investigational toric IOLs with higher cylinder powers. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Toric IOL |
Investigational Toric IOL |
| OG002 | Higher Cylinder Toric IOL | Investigational Toric IOLs with higher cylinder powers. |
|
|
|
| Secondary | Uncorrected Distance Visual Acuity (UCDVA) | Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean. | Available subjects at the final visit with measured uncorrected distance visual acuity. | Posted | Mean | Standard Deviation | LogMAR acuity values | 6 months after second eye implant |
|
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | All Toric IOLs | Investigational Toric IOLs including high cylinder powers | 6 | 174 | 0 | 174 |
| Retinal Repair | Eye disorders | Systematic Assessment |
|
Study results may be published by PI upon written approval by sponsor (AMO). Any proposed submission for publication or presentation of study data must be provided to AMO 90 days prior to submission for review, comment and approval. Sponsor may delay or withhold submission as necessary (ongoing study activities, patents pending, etc.).