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This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 621 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery | Device | Implantation of 621 lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively | Percentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively, | 6 months |
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Inclusion:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Boao Lecheng Aier Eye Hospital | Qionghai | Hainan | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT LUCIA 621P | Cataract surgery: Implantation of 621 lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT LUCIA 621P | Cataract surgery: Implantation of 621 lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants With a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively | Percentage of Participants with a Monocular CDVA ≤0.3 logMAR at 6 Months Postoperatively, | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
|
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 | CT LUCIA 621P | Cataract surgery: Implantation of 621 lens | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Expected Adverse Events | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CZM Clinical Affairs | Carl Zeiss Meditec AG | +49 30 8540010 | clinicalstudies.meditec.sur@zeiss.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2022 | May 22, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2023 | May 22, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| best corrected visual acuity | Mean | Standard Deviation | LogMar |
|
| uncorrected visual acuity | Mean | Standard Deviation | LogMar |
|
|
| 105 |
| 0 |
| 105 |
| 9 |
| 105 |
| Adverse Events Related to Study Device | Eye disorders | Systematic Assessment |
|
| Adverse Events Related to Surgery | Eye disorders | Systematic Assessment |
|
| Adverse Events Requiring Corrective Treatment | Eye disorders | Systematic Assessment |
|
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