Clinical trial NCT04617080: Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
Official title: Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- ocular comorbidity

Primary outcomes:
measure: Binocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months follow up
Secondary outcomes:
measure: Monocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months follow up
measure: Monocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months follow up
measure: Binocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months follow up
measure: Monocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 3 months follow up
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 3 months follow up
measure: Monocular Uncorrected Near Visual Acuity (UNVA)
timeFrame: 3 months follow up
measure: Binocular Uncorrected Near Visual Acuity (UNVA)
timeFrame: 3 months follow up
measure: Binocular Defocus Curve
timeFrame: 3 months follow up
measure: Binocular Contrast sensitivity
timeFrame: 3 months follow up
measure: Halo Photic phenomena
timeFrame: 3 months follow up
measure: Glare Photic phenomena
timeFrame: 3 months follow up
measure: Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
timeFrame: 3 months follow up
measure: Near Activity Visual Questionnaire (NAVQ)
timeFrame: 3 months follow up
Other outcomes:
measure: Binocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 12 months follow up
measure: Monocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 12 months follow up
measure: Monocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 12 months follow up
measure: Binocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 12 months follow up
measure: Monocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 12 months follow up
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 12 months follow up
measure: Monocular Uncorrected Near Visual Acuity (UNVA)
timeFrame: 12 months follow up
measure: Binocular Uncorrected Near Visual Acuity (UNVA)
timeFrame: 12 months follow up
measure: Binocular Defocus Curve
timeFrame: 12 months follow up
measure: Binocular Contrast sensitivity
timeFrame: 12 months follow up
measure: Halo Photic phenomena
timeFrame: 12 months follow up
measure: Glare Photic phenomena
timeFrame: 12 months follow up
measure: Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
timeFrame: 12 months follow up
measure: Near Activity Visual Questionnaire (NAVQ)
timeFrame: 12 months follow up
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
affiliation: Asian Eye Institute
name: Robert Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: