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The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalens toric IOL | Experimental | Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) |
|
| Crystalens IOL | Active Comparator | Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toric Accommodating Lens | Device | Toric accommodating lens implanted after cataract extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Absolute Cylinder | Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error. | 120 - 180 day postoperative visit |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Misalignment | This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not. | 120 - 180 day postoperative visit |
| Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Pepose, MD, PhD | Pepose Vision Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| B&L Surgical | Bridgewater | New Jersey | 08807 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crystalens Toric IOL | Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) |
| FG001 | Crystalens IOL | Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crystalens Toric IOL | Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) |
| BG001 | Crystalens IOL | Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) |
| 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 | Percent Reduction in Absolute Cylinder | Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error. | The analysis population only includes those for whom the outcome was measured within the specified time frame. | Posted | Mean | 95% Confidence Interval | percentage of intended cylinder reduct | 120 - 180 day postoperative visit |
|
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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 | Crystalens Toric IOL | Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopulmonary aspergillosis allergic | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Bausch & Lomb, a division of Valeant Corporation | 908-541-2179 | Johnson.Varughese@valeant.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D000075542 | Multifocal Intraocular Lenses |
| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Accommodating Lens | Device | Accommodating lens implanted after cataract extraction |
|
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
| 120 - 180 day postoperative visit |
| Surgical complication preventing implant |
|
| Death |
|
| Subject explanted |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Crystalens IOL | Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) Accommodating Lens: Accommodating lens implanted during cataract extraction |
|
|
| Secondary | Lens Misalignment | This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not. | The analysis population only includes those for whom the outcome was measured within the specified time frame. | Posted | Mean | Standard Deviation | degrees | 120 - 180 day postoperative visit |
|
|
|
| Secondary | Visual Acuity | Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR) | The analysis population only includes those for whom the outcome was measured within the specified time frame. | Posted | Mean | Standard Deviation | logMAR | 120 - 180 day postoperative visit |
|
|
|
| 16 |
| 153 |
| 47 |
| 153 |
| EG001 | Crystalens IOL | Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) Accommodating Lens: Accommodating lens implanted during cataract extraction | 6 | 76 | 29 | 76 |
| High grade B-cell lymphoma, Burkitt-like lymphoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Optic neuropathy | Eye disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Device dislocation | General disorders | Systematic Assessment |
|
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Cataract operation complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bone sarcoma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Corneal oedema | Eye disorders | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | Systematic Assessment |
|
For a period of ten years, the PI agrees to keep confidential and not disclose, without the prior written consent of Sponsor, to any third party or use any technology, data, reports, results of clinical studies conducted under this Study or other information received by Sponsor, or any technology, data, reports, study materials, or other information developed by Sponsor unless disclosure by PI is required by law.
| D019736 |
| Prostheses and Implants |