Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argos, Then IOLMaster 700 | Biometry measurements first with the Argos device followed by the IOLMaster 700 device. |
| |
| IOLMaster 700, Then Argos | Biometry measurements first with the IOLMaster 700 device followed by the Argos device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argos | Diagnostic Test | Biometry measurements first with the Argos device, then the IOLMaster 700 device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute Prediction Error (D) | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Absolute Prediction Error 0.5 D or Less | 1 month postoperatively | |
| Median Absolute Prediction Error (D) | 1 month postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults presenting with clinically significant cataracts.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sam Multack, D.O. | Multack Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multack Eye Care | Frankfort | Illinois | 60423 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Argos, Then IOLMaster 700 | Biometry measurements first with the Argos device followed by the IOLMaster 700 device. |
| FG001 | IOLMaster 700, Then Argos | Biometry measurements first with the IOLMaster 700 device followed by the Argos device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects |
| 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 | Mean Absolute Prediction Error (D) | Posted | Mean | Standard Deviation | diopters | 1 month postoperatively |
|
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argos | Biometry measurements with the Argos device. | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sam Multack | Multack Eye Care | 815-889-3333 | smultack@mecvision.com |
Not provided
| 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 | Nov 1, 2021 | Oct 25, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| IOLMaster 700 | Diagnostic Test | Biometry measurements first with the IOLMaster 700 device, then the Argos device. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Percentage of Eyes With Absolute Prediction Error 0.5 D or Less | Posted | Number | percent | 1 month postoperatively | Eyes | Eyes |
|
|
|
| Secondary | Median Absolute Prediction Error (D) | Posted | Median | Inter-Quartile Range | diopters | 1 month postoperatively |
|
|
|
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | IOLMaster 700 | Biometry measurements with the IOLMaster 700 device. | 0 | 80 | 0 | 80 | 0 | 80 |
Not provided
Not provided
Not provided