An interventional study of Clareon® IOL and Cataract Surgery in Cataract and Aphakia, sponsored by Alcon Research. Completed at 19 sites in 7 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye surgery).
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 245 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:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system as a replacement of the human crystalline lens during cataract surgery
Device: Clareon® IOL · Procedure: Cataract Surgery
Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.
Also known as: Model SY60WF
Routine small incision cataract surgery with unilateral IOL implantation
Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation
Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\].
Time frame: Year 1 post-implantation from second eye surgery
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).
Time frame: Year 1 post-implantation from second eye surgery
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 1 post-implantation from second eye surgery
UCDVA at 1 Year Post-Implantation - Second Implanted Eye
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 1 post-implantation from second eye surgery
UCDVA at 2 Years Post-Implantation - First Implanted Eye
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
UCDVA at 2 Years Post-Implantation - Second Implanted Eye
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 2 post-implantation from second eye surgery
UCDVA at 3 Years Post-Implantation - First Implanted Eye
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
UCDVA at 3 Years Post-Implantation - Second Implanted Eye
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
Time frame: Year 3 post-implantation from second eye surgery
Study participants were recruited from 19 study centers located in Australia (n = 3), France (n = 2), Germany (n = 2), Italy (n = 2), the Netherlands (n = 2), Spain (n = 5), and the United Kingdom (n = 3).
| Milestone | Clareon IOL |
|---|---|
| Started | 215 |
| Implanted in first eye only | 215 |
| Implanted in second eye only | 209 |
| Implanted in 1 eye only | 6 |
| Completed | 183 |
| Not completed | 32 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 10 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Covid related | 8 |
Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\].
| percentage of first implanted eyes | Clareon IOL |
|---|---|
| Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation | 99.5 (97.2 to 100.0) |
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).
| percentage of second implanted eyes | Clareon IOL |
|---|---|
| Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation | 99.5 (97.2 to 100.0) |
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
| percentage of second implanted eyes | Clareon IOL |
|---|---|
| Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation | 99.5 (97.1 to 100.0) |
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
| percentage of second implanted eyes | Clareon IOL |
|---|---|
| Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation | 98.9 (96.2 to 99.9) |
VA was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
| percentage of first implanted eyes | Clareon IOL |
|---|---|
| Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation | 99.5 (97.0 to 100.0) |
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. No hypothesis testing was prespecified for this endpoint.
| percentage of second implanted eyes | Clareon IOL |
|---|---|
| Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation | 98.9 (96.1 to 99.9) |
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
| logMAR | Clareon IOL |
|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye | 0.079 ± 0.1499 |
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
| logMAR | Clareon IOL |
|---|---|
| UCDVA at 1 Year Post-Implantation - Second Implanted Eye | 0.058 ± 0.1364 |
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
| logMAR | Clareon IOL |
|---|---|
| UCDVA at 2 Years Post-Implantation - First Implanted Eye | 0.088 ± 0.1533 |
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
| logMAR | Clareon IOL |
|---|---|
| UCDVA at 2 Years Post-Implantation - Second Implanted Eye | 0.083 ± 0.1624 |
VA was tested for the first implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
| logMAR | Clareon IOL |
|---|---|
| UCDVA at 3 Years Post-Implantation - First Implanted Eye | 0.091 ± 0.1614 |
VA was tested for the second implanted eye without visual correction using 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A UCDVA of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity, with a lower numeric value representing better visual acuity. No hypothesis testing was prespecified for this endpoint.
| logMAR | Clareon IOL |
|---|---|
| UCDVA at 3 Years Post-Implantation - Second Implanted Eye | 0.086 ± 0.1706 |
Collected over Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 990-1140 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pretreatment | 0/215 (0%) | 0/215 (0%) | 0/215 (0%) |
| SY60WF First Eye | 0/215 (0%) | 6/215 (2.8%) | 34/215 (15.8%) |
| SY60WF Second Eye | 0/209 (0%) | 4/209 (1.9%) | 39/209 (18.7%) |
| SY60WF Systemic | 10/215 (4.7%) | 31/215 (14.4%) | 0/215 (0%) |
| Event | Pretreatment | SY60WF First Eye | SY60WF Second Eye | SY60WF Systemic |
|---|---|---|---|---|
| Intra-ocular injectionSurgical and medical procedures | 0/215 | 4/215 | 2/209 | 0/215 |
| Myocardial infarctionCardiac disorders | 0/215 | 0/215 | 0/209 | 3/215 |
| COVID-19Infections and infestations | 0/215 | 0/215 | 0/209 | 3/215 |
| Cystoid macular oedemaEye disorders | 0/215 | 2/215 | 0/209 | 0/215 |
| Multiple organ dysfunction syndromeGeneral disorders | 0/215 | 0/215 | 0/209 | 2/215 |
| Biliary sepsisInfections and infestations | 0/215 | 0/215 | 0/209 | 2/215 |
| Age-related macular degenerationEye disorders | 0/215 | 1/215 | 1/209 | 0/215 |
| IridocyclitisEye disorders | 0/215 | 1/215 | 1/209 | 0/215 |
| Retinal vein occlusionEye disorders | 0/215 | 1/215 | 1/209 | 0/215 |
| Anterior capsular ruptureInjury, poisoning and procedural complications | 0/215 | 0/215 | 1/209 | 0/215 |
| Event | Pretreatment | SY60WF First Eye | SY60WF Second Eye | SY60WF Systemic |
|---|---|---|---|---|
| Dry eyeEye disorders | 0/215 | 23/215 | 22/209 | 0/215 |
| Posterior capsule opacificationEye disorders | 0/215 | 11/215 | 19/209 | 0/215 |
All Implanted Analysis Set: All subjects/eyes with successful test article implantation
| Age, Continuous(years) | Clareon IOL |
|---|---|
| Mean | 72.1 ± 8.07 |
| Sex: Female, Male(Participants) | Clareon IOL |
|---|---|
| Female | 126 |
| Male | 89 |
| Ethnicity (NIH/OMB)(Participants) | Clareon IOL |
|---|---|
| Hispanic or Latino | 17 |
| Not Hispanic or Latino | 195 |
| Unknown or Not Reported | 3 |
| Race/Ethnicity, Customized(Participants) | Clareon IOL |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 3 |
| White | 204 |
| More than one race | 0 |
| Other | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Oct 2019, 19 months.
Results were first posted in Aug 2023, 3 years 10 months 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 19 months is above 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 Aug 2023. You cannot join it, but the record below documents what was studied.
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