An interventional study of Clareon IOL and Clareon Toric IOL in Cataract and Aphakia, sponsored by Alcon Research. Completed at 8 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 203 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Clareon IOL · Device: Clareon Toric IOL · Procedure: Phacoemulsification surgery
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.
Device: Eyhance IOL · Device: Eyhance Toric IOL · Procedure: Phacoemulsification surgery
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.
Also known as: Model SY60WF
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.
Also known as: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6 as available
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.
Also known as: Model DIB00
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.
Also known as: Models DIU150, DIU225, DIU300, DIU375 as available
Cataract removal by routine small incision phacoemulsification surgery
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.
Time frame: Month 3 postoperative visit
Subjects were recruited from 8 investigative sites located in the United States.
| Milestone | Clareon/Clareon Toric | Eyhance/Eyhance Toric |
|---|---|---|
| Started | 89 | 86 |
| First eye implanted | 89 | 86 |
| Second eye implanted | 86 | 84 |
| Completed | 88 | 84 |
| Not completed | 1 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| logMAR | Clareon/Clareon Toric | Eyhance/Eyhance Toric |
|---|---|---|
| Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions | -0.100 ± 0.0880 | -0.055 ± 0.0716 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/175 (0%) | 0/175 (0%) | 0/175 (0%) |
| Clareon/Clareon Toric First Eye | 0/89 (0%) | 2/89 (2.2%) | 11/89 (12.4%) |
| Clareon/Clareon Toric Second Eye | 0/86 (0%) | 0/86 (0%) | 8/86 (9.3%) |
| Clareon/Clareon Toric Systemic | 0/89 (0%) | 2/89 (2.2%) | 0/89 (0%) |
| Eyhance/Eyhance Toric First Eye | 0/86 (0%) | 2/86 (2.3%) | 6/86 (7%) |
| Eyhance/Eyhance Toric Second Eye | 0/84 (0%) | 0/84 (0%) | 7/84 (8.3%) |
| Eyhance/Eyhance Toric Systemic | 0/86 (0%) | 3/86 (3.5%) | 0/86 (0%) |
| Event | Pretreatment | Clareon/Clareon Toric First Eye | Clareon/Clareon Toric Second Eye | Clareon/Clareon Toric Systemic | Eyhance/Eyhance Toric First Eye | Eyhance/Eyhance Toric Second Eye | Eyhance/Eyhance Toric Systemic |
|---|---|---|---|---|---|---|---|
| Ciliary zonular weaknessEye disorders | 0/175 | 0/89 | 0/86 | 0/89 | 1/86 | 0/84 | 0/86 |
| Cystoid macular oedemaEye disorders | 0/175 | 0/89 | 0/86 | 0/89 | 1/86 | 0/84 | 0/86 |
| FallInjury, poisoning and procedural complications | 0/175 | 0/89 | 0/86 | 0/89 | 0/86 | 0/84 | 1/86 |
| Hip fractureInjury, poisoning and procedural complications | 0/175 | 0/89 | 0/86 | 0/89 | 0/86 | 0/84 | 1/86 |
| Intraocular pressure increasedInvestigations | 0/175 | 0/89 | 0/86 | 0/89 | 1/86 | 0/84 | 0/86 |
| HypomagnesaemiaMetabolism and nutrition disorders | 0/175 | 0/89 | 0/86 | 0/89 | 0/86 | 0/84 | 1/86 |
| Iris disorderEye disorders | 0/175 | 1/89 | 0/86 | 0/89 | 0/86 | 0/84 | 0/86 |
| AstheniaGeneral disorders | 0/175 | 0/89 | 0/86 | 1/89 | 0/86 | 0/84 | 0/86 |
| AppendicitisInfections and infestations | 0/175 | 0/89 | 0/86 | 1/89 | 0/86 | 0/84 | 0/86 |
| Device dislocationProduct Issues | 0/175 | 1/89 | 0/86 | 0/89 | 0/86 | 0/84 | 0/86 |
| Event | Pretreatment | Clareon/Clareon Toric First Eye | Clareon/Clareon Toric Second Eye | Clareon/Clareon Toric Systemic | Eyhance/Eyhance Toric First Eye | Eyhance/Eyhance Toric Second Eye | Eyhance/Eyhance Toric Systemic |
|---|---|---|---|---|---|---|---|
| Intraocular pressure increasedInvestigations | 0/175 | 6/89 | 5/86 | 0/89 | 5/86 | 6/84 | 0/86 |
| Posterior capsule opacificationEye disorders | 0/175 | 5/89 | 4/86 | 0/89 | 1/86 | 1/84 | 0/86 |
All Implanted Analysis Set (AAS): All eyes with successful study IOL implantation and with at least one postoperative visit.
| Age, Continuous(years) | Clareon/Clareon Toric | Eyhance/Eyhance Toric | Total |
|---|---|---|---|
| Mean | 69.0 ± 7.63 | 70.4 ± 7.73 | 69.7 ± 7.69 |
| Sex: Female, Male(Participants) | Clareon/Clareon Toric | Eyhance/Eyhance Toric | Total |
|---|---|---|---|
| Female | 47 | 54 | 101 |
| Male | 42 | 32 | 74 |
| Ethnicity (NIH/OMB)(Participants) | Clareon/Clareon Toric | Eyhance/Eyhance Toric | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 12 | 23 |
| Not Hispanic or Latino | 77 | 74 | 151 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Clareon/Clareon Toric | Eyhance/Eyhance Toric | Total |
|---|---|---|---|
| White | 70 | 74 | 144 |
| Black or African American | 15 | 9 | 24 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 3 | 3 | 6 |
| Region of Enrollment(participants) | Clareon/Clareon Toric | Eyhance/Eyhance Toric | Total |
|---|---|---|---|
| United States | 89 | 86 | 175 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2022 to primary completion in Oct 2023, 12 months.
Results were first posted in Oct 2024, 1 year after primary completion.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 12 months is below that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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