Visual Outcomes and Patient Satisfaction With Implantatio... | NCT05526781

Name	Class
Sengi	INDUSTRY

Label	Type	Description	Intervention Names
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)

Name	Type	Description	Arm Group Labels	Other Names
Clareon monofocal Intraocular lens (toric and non-toric models)	Device	Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter

Measure	Description	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

Measure	Description	Time Frame
Monocular Uncorrected Intermediate Visual Acuity (66cm)		3 months postoperative
Binocular Uncorrected Intermediate Visual Acuity (66cm)		3 months postoperative

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Joesph Christenbury, MD	Eye Consultants of Atlanta	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Eye Consultants of Atlanta		Atlanta	Georgia	30339	United States

ID	Title	Description
FG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 10, 2022

ID	Title	Description
BG000	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

Units	Counts
Participants	BG00028

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Monocular Uncorrected Distance Visual Acuity (6m)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028
eyes	OG00056

Title

Denominators

Categories

Title	Measurements
	OG0000.06± 0.07

Primary

Binocular Uncorrected Distance Visual Acuity (6m)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028

Primary

Binocular Corrected Distance Visual Acuity (6m)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028

Primary

Monocular Corrected Distance Visual Acuity (6m)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028
eyes

Secondary

Monocular Uncorrected Intermediate Visual Acuity (66cm)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028
eyes

Secondary

Binocular Uncorrected Intermediate Visual Acuity (66cm)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028

Secondary

Binocular Distance Corrected Intermediate Visual Acuity (66cm)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028

Secondary

Monocular Distance Corrected Intermediate Visual Acuity (66cm)

Posted

Mean

Standard Deviation

logMAR

3 months postoperative

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028
eyes

Secondary

Manifest Refraction Spherical Equivalent (MRSE)

The percentage of eyes with MRSE within ± 0.5 D.

Posted

Count of Units

eyes

3 months postoperative

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG00028

Secondary

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".

Posted

Count of Units

eyes

Operative visit (Day 0)

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG000

Secondary

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".

Posted

Count of Units

eyes

Operative visit (Day 0)

eyes

ID	Title	Description
OG000	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

Units	Counts
Participants	OG000

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases