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To establish the safety and effectiveness of the CT LUCIA 611P posterior chamber intraocular lens for the correction of aphakia following extracapsular cataract extraction via phacoemulsification in adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL | Device | Intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Distance Visual Acuity | Proportion of subjects achieving BCDVA 0.3 logMAR or better | postoperative days 330-420 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Argus Research at Cape Coral Eye Center | Cape Coral | Florida | 33904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35333839 | Derived | Schallhorn SC, Bonilla M, Pantanelli SM. Outcomes of a multicenter U.S. clinical trial of a new monofocal single-piece hydrophobic acrylic IOL. J Cataract Refract Surg. 2022 Oct 1;48(10):1126-1133. doi: 10.1097/j.jcrs.0000000000000943. Epub 2022 Mar 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | IOL: Intraocular lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | IOL: Intraocular lens |
| 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 | Best Corrected Distance Visual Acuity | Proportion of subjects achieving BCDVA 0.3 logMAR or better | Posted | Count of Participants | Participants | postoperative days 330-420 |
|
|
1 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 | Treatment Group | IOL: Intraocular lens | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cystoid macular edema | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bonilla | Carl Zeiss | +1 925-557-4100 | michael.bonilla@zeiss.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2018 | Mar 20, 2023 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 339 |
| 13 |
| 339 |
| 32 |
| 339 |
| Anterior capsular contraction | Eye disorders | Systematic Assessment |
|
| Acute myocardial infraction | Cardiac disorders | Systematic Assessment |
|
| Adverse drug reaction | General disorders | Systematic Assessment |
|
| Aortic aneurysm | Cardiac disorders | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Post procedural complication | Surgical and medical procedures | Systematic Assessment |
|
| Post procedural hemorrhage | Surgical and medical procedures | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sarcoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Spinal compression fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Unevaluable event | General disorders | Systematic Assessment |
|
| Chronic kidney disease | Hepatobiliary disorders | Systematic Assessment |
|
| Intraocular pressure increased | Eye disorders | Systematic Assessment |
|
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