NCT04617080

Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm

Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to correct for ametropia. The participants will be randomized to either a SUPRACOR regular (100%) or SUPRACOR strong (130%) treatment with a 1:1 ratio.

Conditions

• Ametropia

Interventions

Type	Name	Description
PROCEDURE	SUPRACOR Regular	SUPRACOR algorithm with regular (100%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.
PROCEDURE	SUPRACOR Strong	SUPRACOR algorithm with strong (130%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.

Timeline

• Start date: 2020-01-26
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2020-11-05
• Last updated: 2024-03-01

Locations

1 site across 1 country: Philippines