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

NCT05526781 | Completed Results FDA Device

• 1 other identifier: JC-22-001
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• 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

Study Arms (1)

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)

Interventions

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

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye Consultants of Atlanta: lead
• Sengi: collaborator

Study Sites (1)

Eye Consultants of Atlanta

Atlanta, Georgia, 30339, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Joseph Christenbury
• Organization: Eye Consultants of Atlanta

jchristenbury@eyeconsultants.net

14043512220

Study Officials

• Joesph Christenbury, MD

  Eye Consultants of Atlanta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 2, 2022
• Study Start: September 21, 2022
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)