NCT05526781

Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System

Completed Results posted Last updated 26 March 2025

What this trial tests

trial testing Clareon monofocal Intraocular lens (toric and non-toric models) in Cataract in 34 participants. Completed in 12 March 2024.

Timeline

21 September 2022

Primary endpoint
12 March 2024

12 March 2024

Quick facts

Lead sponsor	Eye Consultants of Atlanta
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	21 September 2022
Primary completion	12 March 2024
Estimated completion	12 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Clareon monofocal Intraocular lens (toric and non-toric models)

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Eye Consultants of Atlanta

Who can join

45 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Monocular Uncorrected Distance Visual Acuity (6m) Primary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.06	± 0.07

Binocular Uncorrected Distance Visual Acuity (6m) Primary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.03	± 0.04

Binocular Corrected Distance Visual Acuity (6m) Primary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.00	± 0.02

Monocular Corrected Distance Visual Acuity (6m) Primary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.00	± 0.02

Monocular Uncorrected Intermediate Visual Acuity (66cm) Secondary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.12	± 0.05

Binocular Uncorrected Intermediate Visual Acuity (66cm) Secondary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.09	± 0.05

Binocular Distance Corrected Intermediate Visual Acuity (66cm) Secondary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.0	± 0.05

Monocular Distance Corrected Intermediate Visual Acuity (66cm) Secondary · 3 months postoperative

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	0.05	± 0.05

Manifest Refraction Spherical Equivalent (MRSE) Secondary · 3 months postoperative

The percentage of eyes with MRSE within ± 0.5 D.

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	51

Overall Surgeon Satisfaction of Monarch IV Delivery Experience Secondary · 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".

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	56

Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV Secondary · 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".

Group	Value	95% CI
Clareon® Monofocal Intraocular Lens (Toric and Non-toric Models)	50

Sponsor's own description

To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Visual Outcomes and Patient Satisfaction with a Hydrophobic Acrylic Monofocal IOL Delivered Using a Manual System.
   Christenbury J, Hall B. · · 2024 · PMID 39624257 · DOI 10.2147/opth.s491589