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

Bausch & Lomb Incorporated1 site in 1 country60 target enrollmentJanuary 26, 2020

ConditionsAmetropia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ametropia
Sponsor: Bausch & Lomb Incorporated
Enrollment: 60
Locations: 1
Primary Endpoint: Binocular Uncorrected Distance Visual Acuity (UDVA)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 26, 2020

End Date

February 28, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•ocular comorbidity

Outcomes

Primary Outcomes

Binocular Uncorrected Distance Visual Acuity (UDVA)

Time Frame: 3 months follow up

The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.

Secondary Outcomes

Glare Photic phenomena(3 months follow up)
Binocular Corrected Distance Visual Acuity (CDVA)(3 months follow up)
Binocular Contrast sensitivity(3 months follow up)
Binocular Uncorrected Near Visual Acuity (UNVA)(3 months follow up)
Monocular Corrected Distance Visual Acuity (CDVA)(3 months follow up)
Monocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months follow up)
Binocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months follow up)
Monocular Uncorrected Near Visual Acuity (UNVA)(3 months follow up)
Binocular Defocus Curve(3 months follow up)
Halo Photic phenomena(3 months follow up)
Monocular Uncorrected Distance Visual Acuity (UDVA)(3 months follow up)
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)(3 months follow up)
Near Activity Visual Questionnaire (NAVQ)(3 months follow up)