Trial Outcomes & Findings for Post-Market Clinical Investigation of the Clareon® IOL (NCT NCT03316885)

Last Updated: 2023-08-21

Results Overview

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% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\].

Recruitment status

COMPLETED

Study phase

Target enrollment

245 participants

Primary outcome timeframe

Year 1 post-implantation from second eye surgery

Results posted on

2023-08-21

Participant Flow

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).

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).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	215 430
Overall Study Implanted in First Eye Only	215 215
Overall Study Implanted in Second Eye Only	209 209
Overall Study Implanted in 1 Eye Only	6 6
Overall Study COMPLETED	183 365
Overall Study NOT COMPLETED	32 65

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	1
Overall Study Death	10
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	9
Overall Study COVID related	8

Baseline Characteristics

Post-Market Clinical Investigation of the Clareon® IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clareon IOL n=215 Participants 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
Age, Continuous	72.1 years STANDARD_DEVIATION 8.07 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized White	204 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Year 1 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

Outcome measures

Outcome measures
Measure	Clareon IOL n=198 first implanted eye 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
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 percentage of first implanted eyes Interval 97.2 to 100.0

PRIMARY outcome

Timeframe: Year 1 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

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).

Outcome measures

Outcome measures
Measure	Clareon IOL n=198 second implanted eye 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
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation	99.5 percentage of second implanted eyes Interval 97.2 to 100.0

SECONDARY outcome

Timeframe: Year 2 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

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.

Outcome measures

Outcome measures
Measure	Clareon IOL n=190 second implanted eye 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
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation	99.5 percentage of second implanted eyes Interval 97.1 to 100.0

SECONDARY outcome

Timeframe: Year 2 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

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.

Outcome measures

Outcome measures
Measure	Clareon IOL n=189 second implanted eye 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
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation	98.9 percentage of second implanted eyes Interval 96.2 to 99.9

SECONDARY outcome

Timeframe: Year 3 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

Outcome measures

Outcome measures
Measure	Clareon IOL n=183 first implanted eye 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
Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation	99.5 percentage of first implanted eyes Interval 97.0 to 100.0

SECONDARY outcome

Timeframe: Year 3 post-implantation from second eye surgery

Population: All Implanted Analysis Set

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.

Outcome measures

Outcome measures
Measure	Clareon IOL n=182 second implanted eye 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
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation	98.9 percentage of second implanted eyes Interval 96.1 to 99.9

SECONDARY outcome

Timeframe: Year 1 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

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.

Outcome measures

Outcome measures
Measure	Clareon IOL n=199 first implanted eye 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
Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye	0.079 logMAR Standard Deviation 0.1499

SECONDARY outcome

Timeframe: Year 1 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

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.

Outcome measures

Outcome measures
Measure	Clareon IOL n=198 second implanted eye 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
UCDVA at 1 Year Post-Implantation - Second Implanted Eye	0.058 logMAR Standard Deviation 0.1364

SECONDARY outcome

Timeframe: Year 2 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

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.

Outcome measures

Outcome measures
Measure	Clareon IOL n=190 first implanted eye 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
UCDVA at 2 Years Post-Implantation - First Implanted Eye	0.088 logMAR Standard Deviation 0.1533

SECONDARY outcome

Timeframe: Year 2 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

Outcome measures

Outcome measures
Measure	Clareon IOL n=189 second implanted eye 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
UCDVA at 2 Years Post-Implantation - Second Implanted Eye	0.083 logMAR Standard Deviation 0.1624

SECONDARY outcome

Timeframe: Year 3 post-implantation from second eye surgery

Population: All Implanted Analysis Set

Outcome measures

Outcome measures
Measure	Clareon IOL n=183 Participants 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
UCDVA at 3 Years Post-Implantation - First Implanted Eye	0.091 logMAR Standard Deviation 0.1614

SECONDARY outcome

Timeframe: Year 3 post-implantation from second eye surgery

Population: All Implanted Analysis Set with data

Outcome measures

Outcome measures
Measure	Clareon IOL n=182 second implanted eye 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
UCDVA at 3 Years Post-Implantation - Second Implanted Eye	0.086 logMAR Standard Deviation 0.1706

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SY60WF First Eye

Serious events: 6 serious events

Other events: 34 other events

Deaths: 0 deaths

SY60WF Second Eye

Serious events: 4 serious events

Other events: 39 other events

Deaths: 0 deaths

SY60WF Systemic

Serious events: 31 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pretreatment n=215 participants at risk Events reported in this group occurred prior to attempted implantation with the test article	SY60WF First Eye n=215 participants at risk Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye	SY60WF Second Eye n=209 participants at risk Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye	SY60WF Systemic n=215 participants at risk Events reported in this group occurred after attempted implantation with the test article
Eye disorders Dry eye	0.00% 0/215 • 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.	10.7% 23/215 • Number of events 24 • 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.	10.5% 22/209 • Number of events 22 • 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.	0.00% 0/215 • 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.
Eye disorders Posterior capsule opacification	0.00% 0/215 • 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.	5.1% 11/215 • Number of events 11 • 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.	9.1% 19/209 • Number of events 19 • 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.	0.00% 0/215 • 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.

Additional Information

Director, Clinical Projects - CDMA Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER