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

Bausch + Lomb

Status: Completed

Conditions: Ametropia

Treatments: Procedure: SUPRACOR Regular; Procedure: SUPRACOR Strong

Study type: Interventional

Funder types: Industry

Identifiers

NCT04617080

BL1901

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presbyopia
• willingness for a refractive presbyopia correction
• signed informed consent form

Exclusion criteria

• ocular comorbidity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

SUPRACOR Regular

Active Comparator group

Treatment:

Procedure: SUPRACOR Regular

SUPRACOR Strong

Experimental group

Treatment:

Procedure: SUPRACOR Strong