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The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.
This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits. The expected individual duration of participation in the study is 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon/Clareon Toric | Experimental | Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery. |
|
| Eyhance/Eyhance Toric | Active Comparator | Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon IOL | Device | Alcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions | Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes. | Month 3 postoperative visit |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CDMA Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seeta Eye Centers | Poughkeepsie | New York | 12603 | United States | ||
| Cleveland Eye Clinic |
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Of the 203 enrolled, 14 subjects were exited prior to randomization as screen failures, and 14 subjects were discontinued after randomization and prior to attempted implantation. This reporting group includes all subjects with attempted implantation per actual treatment (175).
Subjects were recruited from 8 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clareon/Clareon Toric | Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. |
| FG001 | Eyhance/Eyhance Toric | Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Implanted Analysis Set (AAS): All eyes with successful study IOL implantation and with at least one postoperative visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clareon/Clareon Toric | Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. |
| BG001 |
| 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 Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions | Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes. | AAS with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 3 postoperative visit |
|
Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months.
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 eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
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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 | Pretreatment | All subjects in the safety analysis set prior to initiation of treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ciliary zonular weakness | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Projects, 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 | Jun 29, 2023 | Oct 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2023 | Oct 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
|
| Clareon Toric IOL | Device | Clareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject. |
|
|
| Eyhance IOL | Device | TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject. |
|
|
| Eyhance Toric IOL | Device | TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject. |
|
|
| Phacoemulsification surgery | Procedure | Cataract removal by routine small incision phacoemulsification surgery |
|
| Brecksville |
| Ohio |
| 44141 |
| United States |
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Vision for Life | Nashville | Tennessee | 37205 | United States |
| Houston Eye Associates | Houston | Texas | 77008 | United States |
| Berkeley Eye Center | Houston | Texas | 77027 | United States |
| Texas Eye Research Center | Hurst | Texas | 76054 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Withdrawal by Subject |
|
| Eyhance/Eyhance Toric |
Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. |
| 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 |
|
| OG001 | Eyhance/Eyhance Toric | Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery. |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
| EG001 | Clareon/Clareon Toric First Eye | All first study eyes implanted with Clareon/Clareon Toric IOL | 0 | 89 | 2 | 89 | 11 | 89 |
| EG002 | Clareon/Clareon Toric Second Eye | All second study eyes implanted with Clareon/Clareon Toric IOL | 0 | 86 | 0 | 86 | 8 | 86 |
| EG003 | Clareon/Clareon Toric Systemic | All subjects implanted with Clareon/Clareon Toric IOL | 0 | 89 | 2 | 89 | 0 | 89 |
| EG004 | Eyhance/Eyhance Toric First Eye | All first study eyes implanted with Eyhance/Eyhance Toric IOL | 0 | 86 | 2 | 86 | 6 | 86 |
| EG005 | Eyhance/Eyhance Toric Second Eye | All second study eyes implanted with Eyhance/Eyhance Toric IOL | 0 | 84 | 0 | 84 | 7 | 84 |
| EG006 | Eyhance/Eyhance Toric Systemic | All subjects implanted with Eyhance/Eyhance Toric IOL | 0 | 86 | 3 | 86 | 0 | 86 |
| Cystoid macular oedema | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Iris disorder | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA (23.1) | Systematic Assessment |
|
| Intraocular lens repositioning | Surgical and medical procedures | MedDRA (23.1) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.