Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sengi | INDUSTRY |
Not provided
Not provided
Not provided
To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Clareon™ PanOptix™ Trifocal (toric and non-toric models) | Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Clareon™ PanOptix™ Trifocal (toric and non-toric models) | Device | Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance-corrected Near (40 cm) Visual Acuity | 1 month postoperatively | |
| Binocular Distance-corrected Near (40 cm) Visual Acuity | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Distance (6 m) Visual Acuity | 1 and 3 months postoperative | |
| Binocular Uncorrected Intermediate (60 cm) Visual Acuity | 1 and 3 months postoperative | |
Not provided
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
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.
The principal 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.
Not provided
Not provided
Not provided
Not provided
Eligible participants will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for near, intermediate and distance vision, and who are considered appropriate candidates for trifocal lens implantation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas H Newsom, MD | Newsom Eye & Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newsom Eye & Laser Center | Sebring | Florida | 33870 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models) | Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models) | Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) |
| 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 | Binocular Distance-corrected Near (40 cm) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 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 | The Clareon™ PanOptix™ Trifocal (Toric and Non-toric Models) | Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) The Clareon™ PanOptix™ Trifocal (toric and non-toric models): Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T Hunter Newsom | Newsom Eye | 813-908-2020 | hunter@newsomeye.net |
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 | Jul 7, 2022 | Jun 30, 2025 | 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
| Binocular Uncorrected Near (40 cm) Visual Acuity |
| 1 and 3 months postoperative |
| Binocular Corrected Corrected Distance (6 m) Visual Acuity | 1 and 3 months postoperative |
| Binocular Distance-corrected Intermediate (60 cm) Visual Acuity | 1 and 3 months postoperative |
| Manifest Refraction | spherical equivalent refraction and astigmatism less than or equal to 0.5 D. | 3 months postoperative |
| Satisfaction Questionnaire | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome. | 3 months postoperative |
| Visual Disturbances Questionnaire | Questionnaire for Visual Disturbances (QUVID). | 3 months postoperative |
| 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 |
|
|
| Primary | Binocular Distance-corrected Near (40 cm) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 3 months postoperatively |
|
|
|
| Secondary | Binocular Uncorrected Distance (6 m) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 1 and 3 months postoperative |
|
|
|
| Secondary | Binocular Uncorrected Intermediate (60 cm) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 1 and 3 months postoperative |
|
|
|
| Secondary | Binocular Uncorrected Near (40 cm) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 1 and 3 months postoperative |
|
|
|
| Secondary | Binocular Corrected Corrected Distance (6 m) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 1 and 3 months postoperative |
|
|
|
| Secondary | Binocular Distance-corrected Intermediate (60 cm) Visual Acuity | Posted | Mean | Standard Deviation | logMAR | 1 and 3 months postoperative |
|
|
|
| Secondary | Manifest Refraction | spherical equivalent refraction and astigmatism less than or equal to 0.5 D. | Posted | Count of Units | eyes | 3 months postoperative | eyes | eyes |
|
|
|
| Secondary | Satisfaction Questionnaire | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome. | Posted | Count of Participants | Participants | 3 months postoperative |
|
|
|
| Secondary | Visual Disturbances Questionnaire | Questionnaire for Visual Disturbances (QUVID). | Posted | Count of Participants | Participants | 3 months postoperative |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Bothered quite a bit" or "Bothered very much" by haze |
|
| Bothered quite a bit" or "Bothered very much" by blurred vision |
|
| Bothered quite a bit" or "Bothered very much" by double vision |
|
| dark area |
|