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

Completed

Conditions: Cataract

Interventions: Device: Clareon monofocal Intraocular lens (toric and non-toric models)

Registration Number: NCT05526781

Lead Sponsor: Eye Consultants of Atlanta

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clareon® monofocal Intraocular lens (toric and non-toric models)	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

Primary Outcome Measures

Name	Time	Method
Monocular Corrected Distance Visual Acuity (6m)	3 months postoperative
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

Secondary Outcome Measures

Name	Time	Method
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)	3 months postoperative	The percentage of eyes with MRSE within ± 0.5 D.
Overall Surgeon Satisfaction of Monarch IV Delivery Experience	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".
Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV	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".