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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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This is a study to assess the spectacle independence and quality of vision 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 | Patients bilaterally implanted with the Panoptix intraocular lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panoptix | Device | Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Emmetropic Subjects Who Are Spectacle Independent | Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) 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 logMAR uncorrected distance visual acuity | 3 months |
| Binocular Uncorrected Intermediate Visual Acuity | Binocular logMAR uncorrected intermediate visual acuity |
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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 reducing their dependence on spectacles at all distances, and who are appropriate candidates for multifocal lens implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew C Shatz, MD | SightTrust Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SightTrust Eye Institute | Sunrise | Florida | 33323 | 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. | |
| 20505205 | Background | McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26. |
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No current plans exist. If data are shared, they will be de-identified beforehand.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panoptix | Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data were for subjects completing the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Panoptix | Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) 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 Emmetropic Subjects Who Are Spectacle Independent | Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) 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"). | This is the number of emmetropic subjects (subgroup) | Posted | Count of Participants | Participants | 3 months |
|
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 | Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bicycle accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Shatz, MD | SightTrust Eye Institute | 877.878.7890 | ashatz@sighttrust.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 29, 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 Corrected Distance Visual Acuity | Binocular logMAR corrected distance visual acuity | 3 months |
| Binocular Distance-corrected Intermediate Visual Acuity | Binocular distance-corrected intermediate visual acuity in logMAR | 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 |
| Quality of Vision Questionnaire | Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better. | 3 months |
| Overall Spectacle Independence | percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time") | 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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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Binocular Uncorrected Distance Visual Acuity | Binocular logMAR uncorrected distance visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
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| Secondary | Binocular Uncorrected Intermediate Visual Acuity | Binocular logMAR uncorrected intermediate visual acuity | 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 Acuity | 3 months |
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| Secondary | Binocular Corrected Distance Visual Acuity | Binocular logMAR corrected distance visual acuity | Posted | Mean | Standard Deviation | logMAR Acuity | 3 months |
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| Secondary | Binocular Distance-corrected Intermediate Visual Acuity | Binocular distance-corrected intermediate visual acuity in logMAR | Posted | Mean | Standard Deviation | logMAR Acuity | 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 Acuity | 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 | Quality of Vision Questionnaire | Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better. | Posted | Mean | Standard Deviation | Score on a scale (0-100, 0 is best) | 3 months |
|
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| Secondary | Overall Spectacle Independence | percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time") | Posted | Count of Participants | Participants | 3 months |
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