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

NCT ID: NCT04617080

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-26

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Ametropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SUPRACOR Regular

Group Type ACTIVE_COMPARATOR

SUPRACOR Regular

Intervention Type PROCEDURE

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.

SUPRACOR Strong

Group Type EXPERIMENTAL

SUPRACOR Strong

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- ocular comorbidity
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Ang, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Eye Institute

Locations

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Asian Eye Institute

Makati City, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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BL1901

Identifier Type: -

Identifier Source: org_study_id

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