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A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photorefractive keratectomy (PRK)
ALLEGRETTO WAVE EYE-Q excimer laser system
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring PRK, myopia, astigmatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects desiring refractive correction of myopia up to -6.00 Diopter (D) sphere with or without astigmatism 0 to -3.00 D and up to -6.00 D manifest refraction spherical equivalent (MRSE) at the spectacle plane measured by manifest refraction;
  • Minimum best spectacle corrected visual acuity (BSCVA) in the treated eye of 20/25;
  • Uncorrected visual acuity (UCVA) 20/40 or worse in the treated eye;
  • Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions;
  • Stable refraction (within ± 0.5 D), as determined by MRSE for a minimum of 12 months prior to surgery;
  • Demonstrated stable refraction for contact lens wearers, as specified in protocol;
  • Signed informed consent document;
  • Willing and able to comply with schedule for follow-up visits;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Females who are pregnant, lactating, or planning a pregnancy during the time course of the study, or have another condition associated with the fluctuation of hormones that could lead to refractive changes;
  • Participation in other clinical trials during this study;
  • Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
  • Dry eye syndrome as determined by the short questionnaire for dry eye syndrome;
  • Systemic medications that may confound the outcome of the study or increase the risk to the subject by affecting wound healing or tissue repair, including, but not limited to steroids, antimetabolites, immune response modifying drugs, etc.;
  • Nystagmus or any other condition that would prevent a steady gaze during the PRK treatment or other diagnostic tests;
  • Ocular condition that may predispose the subject to future complications;
  • Previous intraocular or corneal surgery;
  • Subjects who desire to have monovision;
  • A known sensitivity to medications used for study procedures, including PRK;
  • Presence or history of any condition or finding that makes the subject unsuitable as a candidate for PRK or study participation or may confound the outcome of the study, in the opinion of the Investigator;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PRK ALLEGRETTO

    Arm Description

    Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation

    Outcomes

    Primary Outcome Measures

    Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively
    Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.
    Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability
    Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
    Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability
    Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
    Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability
    Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
    Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability
    Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
    Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits
    MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
    Cumulative Incidence of Ocular Serious Adverse Events by Eye
    Participants were followed for the duration of the study, an expected average of 24 months.
    Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability
    Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).
    Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability
    Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .
    Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability
    Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2012
    Last Updated
    September 26, 2019
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01699087
    Brief Title
    A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System
    Official Title
    Prospective Safety and Effectiveness Study of PRK for Myopia With or Without Astigmatism Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in subjects undergoing photorefractive keratectomy (PRK) treatment.
    Detailed Description
    This was a prospective, multi-center, single group study. Subjects underwent bilateral PRK in which the second eye was treated no sooner than 1 week and no later than 30 days after the first eye's PRK treatment. Subjects were followed for 2 years after surgery. The protocol underwent 4 amendments. The key differences between the protocol versions were clarifications of the planned analyses and adverse event reporting procedures. There were no changes in the inclusion and exclusion criteria or non-adverse event related study assessments between the protocol versions 1-5. Refractive stability of manifest refraction spherical equivalent (MRSE) and manifest refractive cylinder was defined as established when: At least 95% of the treated eyes had a change ≤ 1.0 diopter between manifest refractions performed at any 2 manifest refractions at least 3 months apart The mean rate of change, as determined by a paired analysis, was ≤ 0.5 diopter per year (0.04 D/month) over the same time period The mean rate of change decreased monotonically over time, with a projected asymptote of zero or a rate of change attributable to normal aging The 95% confidence interval for the mean rate of change included zero or a rate of change attributable to normal aging. Refractive stability was assessed for pairs of visits within an interval and was defined to occur at the latter time point of the first interval at which stability was achieved. In the final amendment to the protocol, 3 secondary objectives were made co-primary in response to Agency comments. All endpoints and analyses were modified to match.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Astigmatism
    Keywords
    PRK, myopia, astigmatism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    176 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRK ALLEGRETTO
    Arm Type
    Experimental
    Arm Description
    Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
    Intervention Type
    Procedure
    Intervention Name(s)
    Photorefractive keratectomy (PRK)
    Intervention Description
    In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.
    Intervention Type
    Device
    Intervention Name(s)
    ALLEGRETTO WAVE EYE-Q excimer laser system
    Other Intervention Name(s)
    ALLEGRETTO WAVE Eye-Q, WaveLight® EX500, WaveNet™ Planning Software, ALLEGRETTO WAVE® EYE-Q excimer laser system (Model 1010-3)
    Intervention Description
    The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery
    Primary Outcome Measure Information:
    Title
    Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively
    Description
    Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability
    Description
    Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability
    Description
    Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability
    Description
    Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability
    Description
    Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits
    Description
    MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
    Time Frame
    Up to Month 24 (post second eye surgery)
    Title
    Cumulative Incidence of Ocular Serious Adverse Events by Eye
    Description
    Participants were followed for the duration of the study, an expected average of 24 months.
    Time Frame
    Up to Month 24 (post second eye surgery)
    Title
    Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability
    Description
    Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability
    Description
    Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .
    Time Frame
    Month 6 (post second eye surgery)
    Title
    Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability
    Description
    Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.
    Time Frame
    Month 6 (post second eye surgery)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects desiring refractive correction of myopia up to -6.00 Diopter (D) sphere with or without astigmatism 0 to -3.00 D and up to -6.00 D manifest refraction spherical equivalent (MRSE) at the spectacle plane measured by manifest refraction; Minimum best spectacle corrected visual acuity (BSCVA) in the treated eye of 20/25; Uncorrected visual acuity (UCVA) 20/40 or worse in the treated eye; Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions; Stable refraction (within ± 0.5 D), as determined by MRSE for a minimum of 12 months prior to surgery; Demonstrated stable refraction for contact lens wearers, as specified in protocol; Signed informed consent document; Willing and able to comply with schedule for follow-up visits; Other protocol-defined inclusion criteria may apply. Exclusion Criteria Females who are pregnant, lactating, or planning a pregnancy during the time course of the study, or have another condition associated with the fluctuation of hormones that could lead to refractive changes; Participation in other clinical trials during this study; Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study; Dry eye syndrome as determined by the short questionnaire for dry eye syndrome; Systemic medications that may confound the outcome of the study or increase the risk to the subject by affecting wound healing or tissue repair, including, but not limited to steroids, antimetabolites, immune response modifying drugs, etc.; Nystagmus or any other condition that would prevent a steady gaze during the PRK treatment or other diagnostic tests; Ocular condition that may predispose the subject to future complications; Previous intraocular or corneal surgery; Subjects who desire to have monovision; A known sensitivity to medications used for study procedures, including PRK; Presence or history of any condition or finding that makes the subject unsuitable as a candidate for PRK or study participation or may confound the outcome of the study, in the opinion of the Investigator; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sr. Clinical Manager, GCRA Surgical
    Organizational Affiliation
    Alcon, a Novartis Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System

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