Trial Outcomes & Findings for Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System (NCT NCT05526781)

NCT ID: NCT05526781

Last Updated: 2025-03-26

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 34 participants
• Primary outcome timeframe: 3 months postoperative
• Results posted on: 2025-03-26

Participant Flow

Participant milestones

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=28 Participants Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Age, Continuous	69.6 years STANDARD_DEVIATION 6.8 • n=28 Participants
Sex/Gender, Customized Sex · Female	13 Participants n=28 Participants
Sex/Gender, Customized Sex · Male	13 Participants n=28 Participants
Sex/Gender, Customized Sex · Not Disclosed	2 Participants n=28 Participants

PRIMARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Monocular Uncorrected Distance Visual Acuity (6m)	0.06 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=28 Participants Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Binocular Uncorrected Distance Visual Acuity (6m)	0.03 logMAR Standard Deviation 0.04

PRIMARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=28 Participants Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Binocular Corrected Distance Visual Acuity (6m)	0.00 logMAR Standard Deviation 0.02

PRIMARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Monocular Corrected Distance Visual Acuity (6m)	0.00 logMAR Standard Deviation 0.02

SECONDARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Monocular Uncorrected Intermediate Visual Acuity (66cm)	0.12 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=28 Participants Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Binocular Uncorrected Intermediate Visual Acuity (66cm)	0.09 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=28 Participants Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Binocular Distance Corrected Intermediate Visual Acuity (66cm)	0.0 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months postoperative

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Monocular Distance Corrected Intermediate Visual Acuity (66cm)	0.05 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months postoperative

The percentage of eyes with MRSE within ± 0.5 D.

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Manifest Refraction Spherical Equivalent (MRSE)	51 eyes

SECONDARY outcome

Timeframe: Operative visit (Day 0)

Score from 1-5. Higher scores indicate high surgeon satisfaction. Satisfaction was determined as the percentages of eyes where the surgeon was "Satisfied" or "Very Satisfied".

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Overall Surgeon Satisfaction of Monarch IV Delivery Experience	56 eyes

SECONDARY outcome

Timeframe: Operative visit (Day 0)

Score from 1-4. Higher scores indicate higher consistency. Outcome measure is the percentage of eyes where the "IOL from cartridge coming out as planar, able to deliver IOL easily and smoothly into capsular bag".

Outcome measures

Measure	Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models) n=56 eyes Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Clareon monofocal Intraocular lens (toric and non-toric models): Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV	50 eyes

Adverse Events

Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Joseph Christenbury

Eye Consultants of Atlanta

Phone: 14043512220

Email: jchristenbury@eyeconsultants.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place