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Background:
Hypothesis:
Unmet Medical Need:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcon PanOptix | Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. |
| |
| Johnson & Johnson Synergy | Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Acuity | Diagnostic Test | Measurement of distance, intermediate and near visual acuity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm | Binocular DCNVA Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m. | Binocular CDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. |
| Measure | Description | Time Frame |
|---|---|---|
| Spectacle Independence Utilizing the IOLSAT. | Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely". | 3 months post operatively |
Inclusion Criteria:
Exclusion Criteria:
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Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or Synergy IOLs.
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Micheletti, MD | Berkeley Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center | Houston | Texas | 77027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcon PanOptix | Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
| FG001 | Johnson & Johnson Synergy | Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcon PanOptix | Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
| 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 DCNVA (Distance Corrected Near Visual Acuity) at 40cm | Binocular DCNVA Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
3 months postoperatively
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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 | Alcon PanOptix | Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tetiana Huff | Berkeley Eye Center | 713-620-7640 | tetiana.huff@berkeleyeye.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 | Feb 13, 2022 | May 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| D019466 | Glare |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Defocus Curve | Diagnostic Test | Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. |
|
| Halo and Glare testing | Diagnostic Test | Measurement to quantify degree of visual loss caused by either halo and/or glare. |
|
|
| Patient Questionnaires | Other | Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
|
|
| 3 months post operatively |
| Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm. | Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m. | Binocular UDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm. | Binocular UIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm. | Binocular UNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Binocular Target Corrected Defocus Curve | Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Patient Reported Satisfaction by IOLSAT Questionnaire. | Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage. | 3 months post operatively |
| Patient Reported Dysphotopsias Questionnaire (QUVID). | Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" for frequency are provided. | 3 months post operatively |
| Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE). | Post operative refraction. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm. | Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | 3 months post operatively |
| BG001 | Johnson & Johnson Synergy | Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| OG001 | Johnson & Johnson Synergy | Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. |
|
|
| Secondary | Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m. | Binocular CDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| Secondary | Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm. | Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| Secondary | Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m. | Binocular UDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| Secondary | Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm. | Binocular UIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| Secondary | Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm. | Binocular UNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| Secondary | Binocular Target Corrected Defocus Curve | Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| Secondary | Patient Reported Satisfaction by IOLSAT Questionnaire. | Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage. | Posted | Number | percentage of participants | 3 months post operatively |
|
|
|
| Secondary | Patient Reported Dysphotopsias Questionnaire (QUVID). | Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" for frequency are provided. | Posted | Number | percentage of participants | 3 months post operatively |
|
|
|
| Secondary | Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE). | Post operative refraction. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | D | 3 months post operatively | eyes | eyes |
|
|
|
| Other Pre-specified | Spectacle Independence Utilizing the IOLSAT. | Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely". | Posted | Number | percentage of participants | 3 months post operatively |
|
|
|
| Other Pre-specified | Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm. | Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum. | Posted | Mean | Standard Deviation | logMAR | 3 months post operatively |
|
|
|
| 0 |
| 153 |
| 0 |
| 153 |
| 0 |
| 153 |
| EG001 | Johnson & Johnson Synergy | Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery. Visual Acuity: Measurement of distance, intermediate and near visual acuity. Defocus Curve: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added. Halo and Glare testing: Measurement to quantify degree of visual loss caused by either halo and/or glare. Patient Questionnaires: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts. | 0 | 77 | 0 | 77 | 0 | 77 |
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| D009799 | Ocular Physiological Phenomena |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D055585 | Physical Phenomena |
| -2.00 D |
|
| -1.50 D |
|
| -1.00 D |
|
| -0.50 D |
|
| -0.25 D |
|
| 0.00 D |
|
| 0.25 D |
|
| 0.50 D |
|
| 1.00 D |
|
| Glare |
|
| Haze |
|
| Blurred Vision |
|
| Double Vision |
|
| Dark Area |
|
| Intermediate |
|
| Near |
|