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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.
This study is a single-arm unmasked clinical evaluation study of spectacle independence 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 spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panoptix | Bilateral implantation of the Panoptix trifocal IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panoptix | Device | Panoptix trifocal intraocular lens (IOL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Have Spectacle Independence | Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time") | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Distance Visual Acuity | Binocular uncorrected distance visual acuity in logMAR | 3 months |
| Binocular Uncorrected Intermediate Visual Acuity | Binocular uncorrected intermediate visual acuity in logMAR |
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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.
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Subjects ≥40 years of age presenting for cataract surgery who are interested in spectacle lens freedom and considered appropriate candidates for multifocal lens implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Clayton G Blehm, MD | Gainesville Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville Eye Associates | Gainesville | Georgia | 30501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28341605 | Background | Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panoptix | Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Panoptix | Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL) |
| 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 | Number of Participants Who Have Spectacle Independence | Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time") | Posted | Count of Participants | Participants | 3 months |
|
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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 | Panoptix | Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Blehm, MD | Gainesville Eye Associates | 17705324444 | claytonblehm@gmail.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 | Aug 28, 2019 | Jul 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 3 months |
| Binocular Uncorrected Near Visual Acuity | Binocular logMAR uncorrected near visual acuity | 3 months |
| Binocular Best-corrected Distance Visual Acuity | Binocular logMAR best-corrected distance visual acuity | 3 months |
| Binocular Distance-corrected Intermediate Visual Acuity | Binocular distance-corrected logMAR intermediate visual acuity | 3 months |
| Binocular Distance-corrected Near Visual Acuity | Binocular logMAR distance-corrected near visual acuity | 3 months |
| Spherical Equivalent Refraction | Spherical equivalent refraction in diopters | 3 months |
| Residual Refractive Cylinder | Residual refractive cylinder in diopters | 3 months |
| Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup | Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction | 3 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Binocular Uncorrected Distance Visual Acuity | Binocular uncorrected distance visual acuity in logMAR | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Binocular Uncorrected Intermediate Visual Acuity | Binocular uncorrected intermediate visual acuity in logMAR | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Binocular Uncorrected Near Visual Acuity | Binocular logMAR uncorrected near visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Binocular Best-corrected Distance Visual Acuity | Binocular logMAR best-corrected distance visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Binocular Distance-corrected Intermediate Visual Acuity | Binocular distance-corrected logMAR intermediate visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Binocular Distance-corrected Near Visual Acuity | Binocular logMAR distance-corrected near visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Spherical Equivalent Refraction | Spherical equivalent refraction in diopters | Posted | Mean | Standard Deviation | diopters | 3 months |
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| Secondary | Residual Refractive Cylinder | Residual refractive cylinder in diopters | Posted | Mean | Standard Deviation | diopters | 3 months |
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| Secondary | Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup | Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction | This is the number of patients that had a refractive target within 0.50D of intended (emmetropia subgroup) | Posted | Count of Participants | Participants | 3 months |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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