NCT06118944

Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Trieste · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.

Detailed description

The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL respectively. The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses. Considering the modified optical profile of the ICB00 IOL, the primary objective will be the evaluation of visual performance at intermediate distance.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	ICB00 IOL	Bilateral implantation of ICB00 IOL
DEVICE	ZCB00 IOL	Bilateral implantation of ZCB00 IOL
DEVICE	CNA0T0 IOL	Bilateral implantation of CNA0T0 IOL

Timeline

• Start date: 2019-11-11
• Primary completion: 2022-09-30
• Completion: 2023-01-31
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study