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

NCT04617080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Robert Ang, MD · Asian Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-26
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04617080 on ClinicalTrials.gov