Trial Outcomes & Findings for Clinical Investigation of the Clareon® Intraocular Lens (IOL) (NCT NCT03170154)

Last Updated: 2020-08-03

Results Overview

Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.

Recruitment status

COMPLETED

Study phase

Target enrollment

376 participants

Primary outcome timeframe

Month 12 (postoperative)

Results posted on

2020-08-03

Participant Flow

Subjects were recruited at 16 investigative sites located in the United States.

Of the 376 enrolled, 26 subjects did exit the study as screen failures. This reporting group (350) includes all subjects with attempted implantation with the IOL (successful or aborted after contact with the eye).

Participant milestones

Participant milestones
Measure	Clareon IOL Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Overall Study STARTED	350
Overall Study Rotational Stability Sub-study	141
Overall Study COMPLETED	342
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Clareon IOL Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Overall Study Lost to Follow-up	4
Overall Study Death	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clareon IOL n=350 Participants Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Age, Continuous	69.7 years STANDARD_DEVIATION 6.44 • n=93 Participants
Sex: Female, Male Female	213 Participants n=93 Participants
Sex: Female, Male Male	137 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	336 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	29 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	36 Participants n=93 Participants
Race (NIH/OMB) White	273 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=93 Participants
Region of Enrollment United States	350 participants n=93 Participants

PRIMARY outcome

Timeframe: Month 12 (postoperative)

Population: All-Implanted Subjects (AAS): All subjects/eyes with successful IOL implantation and data at visit

Outcome measures

Outcome measures
Measure	Clareon IOL n=342 eyes Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery	Clareon IOL - Ocular Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic Events reported in this group occurred after attempted implantation with the test article.
Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative	99.7 percentage of subjects Interval 98.38 to 99.99	—	—

PRIMARY outcome

Timeframe: Month 12 (postoperative)

Population: Best-Case Analysis Set (BAS): All subjects/eyes successfully implanted with the IOL that had at least 1 postoperative visit, no preoperative ocular pathology, no macular degeneration at any time, and no previous surgery for the correction of refractive errors, with data at visit.

Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.

Outcome measures

Outcome measures
Measure	Clareon IOL n=326 eyes Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery	Clareon IOL - Ocular Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic Events reported in this group occurred after attempted implantation with the test article.
Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative	99.7 percentage of subjects Interval 98.3 to 99.99	—	—

PRIMARY outcome

Timeframe: Day 0 (operative), up to Month 12 (postoperative)

Population: Safety Analysis Set (SAS): All subjects/study eyes with attempted implantation with the test article (successful or aborted after contact with the eye)

Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.

Outcome measures

Outcome measures
Measure	Clareon IOL n=350 Participants Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery	Clareon IOL - Ocular n=350 Participants Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic n=350 Participants Events reported in this group occurred after attempted implantation with the test article.
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye Serious Adverse Events	0 percentage of subjects	2.3 percentage of subjects	4.0 percentage of subjects
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye Non-Serious Adverse Events	1.4 percentage of subjects	27.1 percentage of subjects	15.1 percentage of subjects

SECONDARY outcome

Timeframe: Day 0 (operative), Month 6 (postoperative)

Population: Rotation Analysis Set (RAS): All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit and Month 6 visit.

IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.

Outcome measures

Outcome measures
Measure	Clareon IOL n=124 eyes Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery	Clareon IOL - Ocular Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic Events reported in this group occurred after attempted implantation with the test article.
Mean Absolute IOL Rotation	2.2696 degrees Standard Deviation 3.87231	—	—

SECONDARY outcome

Timeframe: Day 0 (operative)

Population: RAS: All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit.

IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.

Outcome measures

Outcome measures
Measure	Clareon IOL n=131 eyes Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery	Clareon IOL - Ocular Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic Events reported in this group occurred after attempted implantation with the test article.
Mean Absolute IOL Misplacement	5.1163 degrees Standard Deviation 4.90305	—	—

SECONDARY outcome

Timeframe: Day 0 (operative), Month 6 (postoperative)

Population: RAS, with rotation data available at operative visit and Month 6 visit

IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.

Outcome measures

Outcome measures
Measure	Clareon IOL n=124 eyes Clareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery	Clareon IOL - Ocular Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic Events reported in this group occurred after attempted implantation with the test article.
Mean Absolute IOL Misalignment	5.6762 degrees Standard Deviation 6.42510	—	—

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Clareon IOL - Ocular (Study Eye)

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

Systemic and Ocular Non-Study (Non-Clareon) Eye

Serious events: 18 serious events

Other events: 127 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pre-treatment n=350 participants at risk Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the study eye and non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL.	Clareon IOL - Ocular (Study Eye) n=350 participants at risk Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.	Systemic and Ocular Non-Study (Non-Clareon) Eye n=350 participants at risk Events reported in this group occurred after attempted implantation with the test article and may include ocular events in the non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL.
Eye disorders Posterior capsule opacification	0.00% 0/350 • Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (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. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.	5.4% 19/350 • Number of events 19 • Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (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. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.	5.1% 18/350 • Number of events 18 • Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (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. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.
Surgical and medical procedures Cataract operation	1.7% 6/350 • Number of events 6 • Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (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. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.	0.00% 0/350 • Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (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. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.	33.4% 117/350 • Number of events 117 • Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (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. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.

Additional Information

Sr. Clinical Trial Lead, 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