Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.
Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon IOL | Experimental | Clareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon aspheric hydrophobic acrylic monofocal IOL | Device | Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative | Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better. | Month 12 (postoperative) |
| Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative | Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better. | Month 12 (postoperative) |
| Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol. | Day 0 (operative), up to Month 12 (postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absolute IOL Rotation | IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months. | Day 0 (operative), Month 6 (postoperative) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Fresno | California | 93720 | United States | ||
| Alcon Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 376 enrolled, 26 subjects did exit the study as screen failures. This reporting group (350) includes all subjects with attempted implantation with the IOL (successful or aborted after contact with the eye).
Subjects were recruited at 16 investigative sites located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Clareon IOL | Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2018 | Feb 10, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mean Absolute IOL Misplacement | IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement. | Day 0 (operative) |
| Mean Absolute IOL Misalignment | IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months. | Day 0 (operative), Month 6 (postoperative) |
| Sacramento |
| California |
| 95815 |
| United States |
| Alcon Investigative Site | San Leandro | California | 94578 | United States |
| Alcon Investigative Site | Deerfield Beach | Florida | 33064 | United States |
| Alcon Investigative Site | Orland Park | Illinois | 60467 | United States |
| Alcon Investigative Site | Bloomfield Hills | Michigan | 48302 | United States |
| Alcon Investigative Site | Kansas City | Missouri | 64154 | United States |
| Alcon Investigative Site | New York | New York | 10013 | United States |
| Alcon Investigative Site | Poughkeepsie | New York | 12603 | United States |
| Alcon Investigative Site | Elizabeth City | North Carolina | 27909 | United States |
| Alcon Investigative Site | Southern Pines | North Carolina | 28387 | United States |
| Alcon Investigative Site | Florence | South Carolina | 29501 | United States |
| Alcon Investigative Site | Ladson | South Carolina | 29456 | United States |
| Alcon Investigative Site | Austin | Texas | 78731 | United States |
| Alcon Investigative Site | Nacogdoches | Texas | 75965 | United States |
| Alcon Investigative Site | Appleton | Wisconsin | 54914 | United States |
| Rotational Stability Sub-study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All-Implanted (AAS): All subjects with successful IOL implantation
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clareon IOL | Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative | Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better. | All-Implanted Subjects (AAS): All subjects/eyes with successful IOL implantation and data at visit | Posted | Number | 95% Confidence Interval | percentage of subjects | Month 12 (postoperative) | eyes | eyes |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative | Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better. | Best-Case Analysis Set (BAS): All subjects/eyes successfully implanted with the IOL that had at least 1 postoperative visit, no preoperative ocular pathology, no macular degeneration at any time, and no previous surgery for the correction of refractive errors, with data at visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | Month 12 (postoperative) | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye | Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol. | Safety Analysis Set (SAS): All subjects/study eyes with attempted implantation with the test article (successful or aborted after contact with the eye) | Posted | Number | percentage of subjects | Day 0 (operative), up to Month 12 (postoperative) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute IOL Rotation | IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months. | Rotation Analysis Set (RAS): All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit and Month 6 visit. | Posted | Mean | Standard Deviation | degrees | Day 0 (operative), Month 6 (postoperative) | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute IOL Misplacement | IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement. | RAS: All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit. | Posted | Mean | Standard Deviation | degrees | Day 0 (operative) | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Absolute IOL Misalignment | IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months. | RAS, with rotation data available at operative visit and Month 6 visit | Posted | Mean | Standard Deviation | degrees | Day 0 (operative), Month 6 (postoperative) | eyes | eyes |
|
|
Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.
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 | Pre-treatment | Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the study eye and non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL. | 0 | 350 | 0 | 350 | 6 | 350 |
| EG001 | Clareon IOL - Ocular (Study Eye) | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye. | 0 | 350 | 8 | 350 | 19 | 350 |
| EG002 | Systemic and Ocular Non-Study (Non-Clareon) Eye | Events reported in this group occurred after attempted implantation with the test article and may include ocular events in the non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL. | 2 | 350 | 18 | 350 | 127 | 350 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cystoid macular oedema | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Corneal operation | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Ophthalmologic treatment | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Radical hysterectomy | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Retinal laser coagulation | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Retinopexy | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Urostomy | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
| |
| Vitrectomy | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment | Pre-planned cataract operations in the non-study eye (non-Clareon eye) (fellow eye) are recorded as adverse events. |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Lead, CDMA Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 19, 2018 | Feb 11, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| eyes |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| eyes |
|
|
| eyes |
|
|
| eyes |
|
|