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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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Phacoemulsification is the most common treatment for cataract surgery in the developed countries and over the years it gained importance due to several factors: small incision, surgery performed under topical anesthesia - which reduce injection-related complications - short recovery time, low post operatory induced astigmatism, and low incidence of surgical complications, when compared to the conventional surgeries. The study evaluates 2 different phacoemulsification devices in patients undergoing routine cataract surgery in both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quatera 700 | Experimental |
| |
| Centurion Vision System | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quatera 700 | Device | Phacoemulsification device |
| |
| Centurion |
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Thickness | Ultrasound pachymetry | Postoperative day 1 |
| Lens Removal Time | from end of rhexis to complete nucleus removal | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
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This was a split-eye study design. Each participant contributed two eyes, with one eye assigned to each intervention arm. Therefore, participants appear in both arms and may be counted more than once across arms in the Participant Flow table.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quatera 700 | Quatera 700 phacoemulsification device |
| FG001 | Centurion | Centurion phacoemulsification device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Baseline demographic characteristics were collected at the participant level. This was a split-eye study in which each participant contributed two eyes, with one eye assigned to each intervention arm. Therefore, baseline characteristics are reported once for the overall participant population rather than separately by intervention arm. |
| 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 | Central Corneal Thickness | Ultrasound pachymetry | Posted | Mean | Standard Deviation | microns | Postoperative day 1 |
|
|
3 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 | Quatera 700 | Quatera 700 phacoemulsification device | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Punctate Keratitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Carolina Eyecare Physicians, LLC | 8438813937 | hps@cepmd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2024 | Feb 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Device |
Phacoemulsification device |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Primary | Lens Removal Time | from end of rhexis to complete nucleus removal | Posted | Mean | Standard Deviation | seconds | Intraoperative |
|
|
|
| 40 |
| 0 |
| 40 |
| 3 |
| 40 |
| EG001 | Centurion | Centurion phacoemulsification device | 0 | 40 | 0 | 40 | 4 | 40 |
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