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

Last updated: March 4, 2025
Sponsor: Eye Consultants of Atlanta
Overall Status: Completed

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

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

Clinical Study ID

NCT05526781
JC-22-001
  • Ages > 45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 significantbilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), withplanned cataract extraction using phacoemulsification, clear corneal incision andClareon 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 Clareontoric with Monarch IV.

  • Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.

Exclusion

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) thatcould affect their satisfaction with surgery.

  • History of neovascular AMD, diabetic macular edema, unstable proliferative diabeticretinopathy, geographic atrophy, branch retinal artery or branch retinal veinocclusion, central retinal artery or central retinal vein occlusion, moderate tosevere 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 traumaor retinal detachment surgery.

  • History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's JohnsonSyndrome.

  • 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

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Clareon monofocal Intraocular lens (toric and non-toric models)
Phase:
Study Start date:
September 21, 2022
Estimated Completion Date:
March 12, 2024

Study 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.

Connect with a study center

  • Eye Consultants of Atlanta

    Atlanta, Georgia 30339
    United States

    Site Not Available

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