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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon IOL | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon® IOL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | 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). | Year 1 post-implantation from second eye surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, CDMA, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Footscray | Victoria | 3011 | Australia | ||
| Alcon Investigative Site |
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Of the 245 enrolled, 30 participants were discontinued from the study prior to attempted implantation with the IOL. This reporting group includes all participants with attempted implantation (215).
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).
| ID | Title | Description |
|---|---|---|
| FG000 | Clareon IOL | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Implanted Analysis Set: All subjects/eyes with successful test article implantation
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| ID | Title | Description |
|---|---|---|
| BG000 | Clareon IOL | 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 |
| 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 | 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]. | All Implanted Analysis Set with data | Posted | Number | 95% Confidence Interval | percentage of first implanted eyes | Year 1 post-implantation from second eye surgery | first implanted eye | first implanted eye |
|
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.
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.
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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 | Events reported in this group occurred prior to attempted implantation with the test article |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (23.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Projects - CDMA 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 | Nov 20, 2019 | Sep 16, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2019 | Sep 16, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Cataract Surgery | Procedure | Routine small incision cataract surgery with unilateral IOL implantation |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Year 3 post-implantation from second eye surgery |
| Mornington |
| Victoria |
| 3931 |
| Australia |
| Alcon Investigative Site | Sydney | 2067 | Australia |
| Alcon Investigative Site | Brest | Cedex | 29609 | France |
| Alcon Investigative Site | Lyon | 69003 | France |
| Alcon Investigative Site | Paris | 75014 | France |
| Alcon Investigative Site | Frankfurt | 60590 | Germany |
| Alcon Investigative Site | Heidelberg | 69120 | Germany |
| Alcon Investigative Site | Perugia | 06129 | Italy |
| Alcon Investigative Site | Pisa | 56124 | Italy |
| Alcon Investigative Site | Amsterdam | 1105AZ | Netherlands |
| Alcon Investigative Site | Jerez de la Frontera | Cadiz | 11408 | Spain |
| Alcon Investigative Site | Alcalá de Henares | 28805 | Spain |
| Alcon Investigative Site | Oviedo | 33012 | Spain |
| Alcon Investigative Site | San Sebastián | 20014 | Spain |
| Alcon Investigative Site | Valencia | 46015 | Spain |
| Alcon Investigative Site | Sutton | Carshalton | SM5 1AA | United Kingdom |
| Alcon Investigative Site | Brighton | BN2 5BF | United Kingdom |
| Alcon Investigative Site | London | EC1V2PD | United Kingdom |
| Withdrawal by Subject |
|
| COVID related |
|
| 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 |
|
| OG000 |
| Clareon IOL |
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 |
|
|
|
| Primary | 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). | All Implanted Analysis Set with data | Posted | Number | 95% Confidence Interval | percentage of second implanted eyes | Year 1 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Number | 95% Confidence Interval | percentage of second implanted eyes | Year 2 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Number | 95% Confidence Interval | percentage of second implanted eyes | Year 2 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Number | 95% Confidence Interval | percentage of first implanted eyes | Year 3 post-implantation from second eye surgery | first implanted eye | first implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set | Posted | Number | 95% Confidence Interval | percentage of second implanted eyes | Year 3 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Mean | Standard Deviation | logMAR | Year 1 post-implantation from second eye surgery | first implanted eye | first implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Mean | Standard Deviation | logMAR | Year 1 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Mean | Standard Deviation | logMAR | Year 2 post-implantation from second eye surgery | first implanted eye | first implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Mean | Standard Deviation | logMAR | Year 2 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set | Posted | Mean | Standard Deviation | logMAR | Year 3 post-implantation from second eye surgery | first implanted eye | first implanted eye |
|
|
|
| Secondary | 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. | All Implanted Analysis Set with data | Posted | Mean | Standard Deviation | logMAR | Year 3 post-implantation from second eye surgery | second implanted eye | second implanted eye |
|
|
|
| 0 |
| 215 |
| 0 |
| 215 |
| 0 |
| 215 |
| EG001 | SY60WF First Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye | 0 | 215 | 6 | 215 | 34 | 215 |
| EG002 | SY60WF Second Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye | 0 | 209 | 4 | 209 | 39 | 209 |
| EG003 | SY60WF Systemic | Events reported in this group occurred after attempted implantation with the test article | 10 | 215 | 31 | 215 | 0 | 215 |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cystoid macular oedema | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Biliary sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Anterior capsular rupture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (23.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
|
| Cerebellar stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cholelithotomy | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
|
| Intra-ocular injection | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
|
| Vitrectomy | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.