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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argos Biometer | Preoperative biometry with the Argos device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argos | Device | Argos Biometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D. | 2 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. | 2 months postoperative | |
| Mean Absolute Prediction Error (in Diopters) | Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better. |
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Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
Each investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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Eligible test subjects will be adults who are interested in and appropriate candidates for cataract surgery.
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| Name | Affiliation | Role |
|---|---|---|
| H J Shammas, MD | Shammes Eye Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colvard-Kandavel Eye Center | Encino | California | 91316 | United States | ||
| Shammas Eye Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Argos Biometer | Preoperative biometry with the Argos device Argos: Argos Biometer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Argos Biometer | Preoperative biometry with the Argos device Argos: Argos Biometer |
| 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 | The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D. | Posted | Count of Units | Eyes | 2 months postoperative | Eyes | Eyes |
|
|
2 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 | Argos Biometer | Preoperative biometry with the Argos device Argos: Argos Biometer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. John Shammas | hammas Eye Medical Center | 3106389391 | hshammas@shammaseye.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 | Sep 16, 2023 | Feb 25, 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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| 2 months postoperative |
| Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm | The Mean Predictive Errors in Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm eyes. Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better. | 2 months postoperative |
| Lynwood |
| California |
| 90262 |
| United States |
| Shammas Eye Center | Whittier | California | 90602 | United States |
| Multack Eye Care, Sc | Frankfort | Illinois | 60461 | United States |
| Multack Eye Care, SC | Olympia Fields | Illinois | 60461 | United States |
| Juliette Eye Institute | Albuquerque | New Mexico | 87113 | United States |
| 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 |
|
| Eyes |
|
|
| Secondary | The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. | Posted | Count of Units | Eyes | 2 months postoperative | Eyes | Eyes |
|
|
|
| Secondary | Mean Absolute Prediction Error (in Diopters) | Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better. | Overall absolute prediction error of two formulas were compared, the BTAL and BUII. The same eyes were used for both formulas. BTAL = Barrett true axial length; BUII = Barrett universal II | Posted | Mean | Standard Deviation | D | 2 months postoperative | Eyes | Eyes |
|
|
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| Secondary | Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm | The Mean Predictive Errors in Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm eyes. Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better. | Absolute prediction error of two formulas were compared in the BTAL and BUII, in different length eyes. The same eyes were used in both formulas. BTAL = Barrett true axial length; BUII = Barrett universal II | Posted | Mean | Standard Deviation | D | 2 months postoperative | Eyes | Eyes |
|
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| 0 |
| 523 |
| 0 |
| 523 |
| 0 |
| 523 |
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| Title | Measurements |
|---|---|
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| Medium Eyes |
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| Short Eyes |
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