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This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.
Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Vivity/Vivity Toric | Experimental | Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
|
| Clareon Monofocal/Clareon Toric | Active Comparator | Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Vivity/Vivity Toric Extended Vision IOL | Device | Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint. | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
| Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint. | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical CRD | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolstan Goldberg Eye Associates | Torrance | California | 90505 | United States | ||
| Eye Center of Northern Colorado, PC |
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Of the 155 enrolled, 5 participants were exited as screen failures. This reporting group includes all eligible subjects (150).
Participants were enrolled at 7 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clareon Vivity/Vivity Toric | Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
| FG001 | Clareon Monofocal/Clareon Toric | Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): All subjects/eyes bilaterally implanted with the test or comparator IOL
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| ID | Title | Description |
|---|---|---|
| BG000 | Clareon Vivity/Vivity Toric | Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
| BG001 | Clareon Monofocal/Clareon Toric |
| 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 | Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visual acuity (VA) was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters (m) using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint. | FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included. | Posted | Mean | Standard Deviation | logMAR | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
|
Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 14 days.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all subjects/eyes bilaterally implanted with the test or comparator IOL.
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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 | Clareon Vivity/Vivity Toric - First Eye (Ocular) | All first study eyes previously implanted with Clareon Vivity/Vivity Toric IOL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2023 | Oct 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Oct 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Assessors will be masked to the IOLs that have been previously implanted in the subject until the end of the study.
|
| Clareon Monofocal/Clareon Toric IOL | Device | Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient. |
|
|
| Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
| Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The percentage was calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome. | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Grosinger, Spigelman & Grey Eye Surgeons, P.C. | Bloomfield Hills | Michigan | 48302 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Carolina Eyecare Physicians LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
| OG001 | Clareon Monofocal/Clareon Toric | Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation |
|
|
|
| Primary | Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. This is a co-primary endpoint. | FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included. | Posted | Mean | Standard Deviation | logMAR | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
|
|
|
|
| Secondary | Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | Visual acuity (VA) was assessed with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 40 centimeters (cm) from the spectacle plane using a visual acuity chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity. This was a subject-based assessment. Both eyes were assessed together. | FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included. | Posted | Mean | Standard Deviation | logMAR | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
|
|
|
|
| Secondary | Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant | The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The percentage was calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. A higher percentage is a better outcome. | FAS with requisite data at visit. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included. | Posted | Number | percentage of participants | Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation) |
|
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | Clareon Vivity/Vivity Toric - Second Eye (Ocular) | All second study eyes previously implanted with Clareon Vivity/Vivity Toric IOL | 0 | 73 | 0 | 73 | 0 | 73 |
| EG002 | Clareon Vivity/Vivity Toric - Systemic | All subjects implanted with Clareon Vivity/Vivity Toric IOL | 0 | 73 | 0 | 73 | 0 | 73 |
| EG003 | Clareon Monofocal/Clareon Toric - First Eye (Ocular) | All first study eyes previously implanted with Clareon Monofocal/Clareon Toric IOL | 0 | 76 | 0 | 76 | 0 | 76 |
| EG004 | Clareon Monofocal/Clareon Toric - Second Eye (Ocular) | All second study eyes previously implanted with Clareon Monofocal/Clareon Toric IOL | 0 | 76 | 0 | 76 | 0 | 76 |
| EG005 | Clareon Monofocal/Clareon Toric - Systemic (Subject) | All subjects implanted with Clareon Monofocal/Clareon Toric IOL | 0 | 76 | 0 | 76 | 0 | 76 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.