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Hyperopic LASIK With Crosslinking Versus Standard LASIK

Primary Purpose

Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LASIK
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperopia

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters

Exclusion Criteria:

  • Patients with previous intraocular or corneal surgery, active corneal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Hyperopic LASIK with crosslinking

    Hyperopic LASIK only

    Arm Description

    group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking

    group 2: hyperopic customized LASIK only

    Outcomes

    Primary Outcome Measures

    assessment of changes in refractive spherical equivalent
    assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent

    Secondary Outcome Measures

    Full Information

    First Posted
    July 15, 2017
    Last Updated
    July 18, 2017
    Sponsor
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03224013
    Brief Title
    Hyperopic LASIK With Crosslinking Versus Standard LASIK
    Official Title
    Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 18, 2016 (Actual)
    Primary Completion Date
    May 12, 2017 (Actual)
    Study Completion Date
    July 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).
    Detailed Description
    Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study. Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperopia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1D to +6D or hyperopic astigmatism up to 4D were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study. Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyperopic LASIK with crosslinking
    Arm Type
    Active Comparator
    Arm Description
    group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking
    Arm Title
    Hyperopic LASIK only
    Arm Type
    Active Comparator
    Arm Description
    group 2: hyperopic customized LASIK only
    Intervention Type
    Procedure
    Intervention Name(s)
    LASIK
    Intervention Description
    LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye
    Primary Outcome Measure Information:
    Title
    assessment of changes in refractive spherical equivalent
    Description
    assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent
    Time Frame
    preoperative and 3 months and 6 months postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    61 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters Exclusion Criteria: Patients with previous intraocular or corneal surgery, active corneal disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jorge L Alio, MD
    Organizational Affiliation
    MD, Phd, FEBO
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hyperopic LASIK With Crosslinking Versus Standard LASIK

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