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The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).
The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZV9003 | Experimental | modified light transmission intraocular lens |
|
| ZA9003 | Active Comparator | monofocal acrylic intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified light transmission intraocular lens | Device | violet visible light blocking acrylic intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Distance Visual Acuity | Snellen Equivalent visual acuity of 20/40 or better | One year |
| Uncorrected Distance Visual Acuity | Snellen Equivalent of 20/40 or better at one year | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Sensitivity | Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger F. Steinert, M.D. | University of California, Irvine, Dept. of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patrick Aiello, M.D. | Scottsdale | Arizona | 85054 | United States | ||
| Randall E. Cole, M.D. |
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250 subjects from normal cataract populations who were undergoing primary phacoemulsification with lens implantation and did not have any other visually significant ocular pathologies were selected at 12 investigation sites across the country
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| ID | Title | Description |
|---|---|---|
| FG000 | ZV9003 Intraocular Lens | modified light transmission intraocular lens |
| FG001 | ZA9003 Intraocular Lens | monofocal acrylic intraocular lens |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| monofocal acrylic intraocular lens | Device | conventional hydrophobic acrylic intraocular lens |
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| 4-6 months |
| Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". | Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit. | One Year |
| Rogers |
| Arkansas |
| 72756 |
| United States |
| Aron Rose, M.D. | New Haven | Connecticut | 06510 | United States |
| Y. Ralph Chu, M.D. | Bloomington | Minnesota | 55420 | United States |
| Steven Silverstein, M.D. | Kansas City | Missouri | 64133 | United States |
| Jon-Marc Weston, M.D. | Roseburg | Oregon | 97470 | United States |
| William Christie, M.D. | Cranberry Township | Pennsylvania | 16066 | United States |
| Mark Blecher, M.D. | Philadelphia | Pennsylvania | 19148 | United States |
| Robert L. Bahr, M.D. | Providence | Rhode Island | 02906 | United States |
| Vance Thompson, M.D. | Sioux Falls | South Dakota | 57105 | United States |
| Jay Rudd, M.D. | Lacey | Washington | 98503 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ZV9003 Intraocular Lens | modified light transmission intraocular lens |
| BG001 | ZA9003 Intraocular Lens | monofocal acrylic intraocular lens |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Best Corrected Distance Visual Acuity | Snellen Equivalent visual acuity of 20/40 or better | One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes. | Posted | Jan 2010 | Number | participants | One year |
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| Secondary | Contrast Sensitivity | Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. | Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported. | Posted | Jan 2011 | Mean | 90% Confidence Interval | log contrast | 4-6 months |
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| Primary | Uncorrected Distance Visual Acuity | Snellen Equivalent of 20/40 or better at one year | One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes. | Posted | Jan 2011 | Number | participants | One Year |
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| Secondary | Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". | Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit. | Two subjects in the ZV9003 group did not complete the one year questionnaire. | Posted | Jan 2011 | Number | participants | One Year |
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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 | ZV9003 Intraocular Lens | modified light transmission intraocular lens | 1 | 126 | 0 | 126 | ||
| EG001 | ZA9003 Intraocular Lens | monofocal acrylic intraocular lens | 1 | 124 | 0 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Tear requiring secondary surgical intervention | Eye disorders | Non-systematic Assessment | Secondary surgical intervention required to repair adverse event of retinal tear. Principal Investigators felt it unlikely retinal tear was lens-related and both adverse events were reported as resolved with sequelae. |
|
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PIs may not publish or disclose study data without Sponsor's prior written approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Taranatino, O.D., Head, Global Clinical Research & Devlopment | Abbott medical Optics, Inc. | 866-427-8477 | 8613 | nicholas.tarantino@amo.abbott.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Between 60 and 69 years |
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| Between 70 and 79 years |
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| >=80 |
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| Male |
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