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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon monofocal Intraocular lens (toric and non-toric models)

Detailed Description

This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Eye Consultants of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be presenting for cataract surgery and who are interested in and appropriate candidates for intraocular lens implantation.

Description

Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.

• Adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV.
• Able to provide written informed consent for participation in the study.
• All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV.
• Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
• History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye.
• History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis.
• History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery.
• History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's Johnson Syndrome.
• History of glaucoma.

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Monocular Uncorrected Distance Visual Acuity (6m)	3 months postoperative
Binocular Uncorrected Distance Visual Acuity (6m)	3 months postoperative
Binocular Corrected Distance Visual Acuity (6m)	3 months postoperative
Monocular Corrected Distance Visual Acuity (6m)	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Uncorrected Intermediate Visual Acuity (66cm)		3 months postoperative
Binocular Uncorrected Intermediate Visual Acuity (66cm)		3 months postoperative
Binocular Distance Corrected Intermediate Visual Acuity (66cm)		3 months postoperative
Monocular Distance Corrected Intermediate Visual Acuity (66cm)		3 months postoperative
Manifest Refraction Spherical Equivalent (MRSE)	The percentage of eyes with MRSE within ± 0.5 D.	3 months postoperative
Overall Surgeon Satisfaction of Monarch IV Delivery Experience	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".	Operative visit (Day 0)
Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV	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".	Operative visit (Day 0)

Collaborators and Investigators

• Sponsor: Eye Consultants of Atlanta
• Collaborators: Sengi
• Investigators: Principal Investigator: Joesph Christenbury, MD, Eye Consultants of Atlanta

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: JC-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes