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The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal Intraocular Lens | Experimental | ZMB00 multifocal intraocular lens |
|
| Monofocal Intraocular Lens | Active Comparator | ZCB00 monofocal intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Piece Tecnis Multifocal IOL | Device | One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group. | 4-6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity | 4-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Szurman, PD Dr. med. | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens |
| FG001 | ZCB00 Monofocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 34 ZMB00 multifocal and 33 ZCB00 monofocal subjects were implanted bilaterally. Data analysis for baseline characteristics was completed on these 67 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens |
| BG001 | ZCB00 Monofocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal 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 | A total of 34 ZMB00 multifocal and 33 ZCB00 monofocal subjects were implanted bilaterally. Data analysis for baseline characteristics was completed on these 67 subjects. |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity | Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit. | Posted | Number | participants | 4-6 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 | ZMB00 Multifocal Intraocular Lens | Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular edema | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. med. Peter Szurman | University Eye Clinic, Tubingen, Germany | 49-7071-29-84915 | peter.szurman@med.uni-tuebingen.de |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| One-Piece Tecnis monofocal IOL, Model ZCB00 | Device | Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens. |
|
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | A total of 34 ZMB00 multifocal and 33 ZCB00 monofocal subjects were implanted bilaterally. Data analysis for baseline characteristics was completed on these 67 subjects. | Count of Participants | Participants |
|
|
|
| Primary | Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group. | Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit. | Posted | Mean | Standard Deviation | logMAR visual acuity | 4-6 Months |
|
|
|
| 0 |
| 36 |
| 3 |
| 36 |
| EG001 | ZCB00 Monofocal Intraocular Lens | Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens | 0 | 34 | 4 | 34 |
| Vitreous detachment | Eye disorders | Systematic Assessment |
|
| IOL replacement secondary to broken haptic during surgery | Eye disorders | Systematic Assessment |
|
| Wound leakage | Eye disorders | Systematic Assessment |
|
| Head injury secondary to car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Head and shoulder injury secondary to wheelchair malfunction | Injury, poisoning and procedural complications | Systematic Assessment |
|
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