NCT05526781

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Eye Consultants of Atlanta · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: —

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.

Conditions

• Cataract

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-03-12
• Completion: 2024-03-12
• First posted: 2022-09-02
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study