Trial Outcomes & Findings for Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens (NCT NCT04936256)

NCT ID: NCT04936256

Last Updated: 2024-08-07

Results Overview

Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)

• Recruitment status: COMPLETED
• Target enrollment: 31 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-08-07

Participant Flow

Participant milestones

Measure	Bilateral Implantation of the Clareon Monofocal IOL Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Overall Study STARTED	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Age, Continuous	72.1 years STANDARD_DEVIATION 5.8 • n=29 Participants
Sex: Female, Male Female	13 Participants n=29 Participants
Sex: Female, Male Male	16 Participants n=29 Participants

PRIMARY outcome

Timeframe: 3 months

Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)

Outcome measures

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Refractive Stability	0.03 Diopters (D) Interval 0.028 to 0.041

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected distance visual acuity in logMAR

Outcome measures

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Binocular Uncorrected Distance Visual Acuity	-0.01 logMAR Standard Deviation 0.1

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected intermediate visual acuity in logMAR

Outcome measures

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Binocular Uncorrected Intermediate Visual Acuity	0.16 logMAR Standard Deviation 0.13

SECONDARY outcome

Timeframe: 3 months

Binocular corrected distance visual acuity in logMAR

Outcome measures

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Binocular Corrected Distance Visual Acuity	-0.04 logMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: 3 months

Binocular distance-corrected intermediate visual acuity in logMAR

Outcome measures

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Binocular Distance-corrected Intermediate Visual Acuity	0.16 logMAR Standard Deviation 0.13

SECONDARY outcome

Timeframe: 3 months

A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D).

Outcome measures

Measure	Bilateral Implantation of the Clareon Monofocal IOL n=29 Participants Clareon monofocal intraocular lens (IOL) Clareon: Clareon monofocal intraocular lens (IOL)
Binocular Defocus Curve -4.0 D	0.90 logMAR Standard Deviation 0.13
Binocular Defocus Curve -3.5 D	0.84 logMAR Standard Deviation 0.14
Binocular Defocus Curve -3.0 D	0.73 logMAR Standard Deviation 0.16
Binocular Defocus Curve -2.5 D	0.64 logMAR Standard Deviation 0.16
Binocular Defocus Curve -2.0 D	0.49 logMAR Standard Deviation 0.16
Binocular Defocus Curve -1.5 D	0.34 logMAR Standard Deviation 0.12
Binocular Defocus Curve -1.0 D	0.20 logMAR Standard Deviation 0.12
Binocular Defocus Curve -0.5 D	0.06 logMAR Standard Deviation 0.11
Binocular Defocus Curve 0.0 D	-0.01 logMAR Standard Deviation 0.11
Binocular Defocus Curve 0.5 D	0.08 logMAR Standard Deviation 0.09
Binocular Defocus Curve 1.0 D	0.25 logMAR Standard Deviation 0.12

Adverse Events

Bilateral Implantation of the Clareon Monofocal IOL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clayton Blehm, MD

Gainesville Eye Associates

Phone: 7705324444

Email: claytonblehm@gmail.com

Results disclosure agreements

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