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Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lenticule extraction
small-incision lenticule extraction
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Refractive Surgical Procedures, small-incision lenticule extraction, lenticule extraction, inflammatory mediators

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • minimum age of 18 years(range from 18 year to 25 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between
  • 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 41.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery

Exclusion Criteria:

  • systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    lenticule extraction

    small-incision lenticule extraction

    Arm Description

    The patients in this group chose to receive the lenticule extraction surgery.

    The patients in this group chose to receive the small-incision lenticule extraction surgery.

    Outcomes

    Primary Outcome Measures

    scale of Schirmer I test
    scale of corneal fluorescein staining
    scale of noninvasive tear breakup time
    questionnaire of ocular surface disease index
    scale of central corneal sensitivity
    scale of tear meniscus height
    concentration of Interleukin-1α
    concentration of tumor necrosis factor-α
    concentration of nerve growth factor
    concentration of interferon-γ
    concentration of transforming growth factor-β1
    concentration of matrix metalloproteinase-9

    Secondary Outcome Measures

    Correlation Between Inflammatory Mediators and Ocular Surface Changes

    Full Information

    First Posted
    August 31, 2015
    Last Updated
    November 24, 2016
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02540785
    Brief Title
    Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction
    Official Title
    Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Between Lenticule Extraction and Small-Incision Lenticule Extraction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) procedures.
    Detailed Description
    The use of femtosecond (FS) laser has become one of the most significant technological advancements in refractive surgery. A breakthrough FS laser-assisted myopic and myopic astigmatic correction procedure can now be performed using a prototype femtosecond system. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE). In FLEx, a corneal flap is created by the FS laser (similar to LASIK) and lifted, allowing lenticule removal. For SMILE, a truly without flap procedure, only a small-2-4mm- incision is made, through which the lenticule is removed. Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery. For both FLEx and SMILE, stromal ablation has been replaced by refractive lenticule removal. In terms of corneal flap formation, FLEx still requires an epithelial-stromal flap, while SMILE employs only a small incision to extract the lenticule. Hence, the investigators hypothesize that SMILE will have less effect on patients' ocular surface markers and inflammatory mediators, compared to FLEx. In support of this hypothesis, previous studies have reported that more damage to the sub-basal nerve plexus of the cornea and more changes in ocular surface evaluations were found after FLEx than after SMILE. In this study, the investigators have focused on postoperative changes to tear inflammatory mediators and the relationship of FLEx and SMILE to dry eye.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Astigmatism
    Keywords
    Refractive Surgical Procedures, small-incision lenticule extraction, lenticule extraction, inflammatory mediators

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lenticule extraction
    Arm Type
    Experimental
    Arm Description
    The patients in this group chose to receive the lenticule extraction surgery.
    Arm Title
    small-incision lenticule extraction
    Arm Type
    Experimental
    Arm Description
    The patients in this group chose to receive the small-incision lenticule extraction surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    lenticule extraction
    Other Intervention Name(s)
    0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
    Intervention Description
    Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully
    Intervention Type
    Procedure
    Intervention Name(s)
    small-incision lenticule extraction
    Other Intervention Name(s)
    0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
    Intervention Description
    Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), make a small incision
    Primary Outcome Measure Information:
    Title
    scale of Schirmer I test
    Time Frame
    up to 1month after surgery
    Title
    scale of corneal fluorescein staining
    Time Frame
    up to 1month after surgery
    Title
    scale of noninvasive tear breakup time
    Time Frame
    up to 1month after surgery
    Title
    questionnaire of ocular surface disease index
    Time Frame
    up to 1month after surgery
    Title
    scale of central corneal sensitivity
    Time Frame
    up to 1month after surgery
    Title
    scale of tear meniscus height
    Time Frame
    up to 1month after surgery
    Title
    concentration of Interleukin-1α
    Time Frame
    up to 1month after surgery
    Title
    concentration of tumor necrosis factor-α
    Time Frame
    up to 1month after surgery
    Title
    concentration of nerve growth factor
    Time Frame
    up to 1month after surgery
    Title
    concentration of interferon-γ
    Time Frame
    up to 1month after surgery
    Title
    concentration of transforming growth factor-β1
    Time Frame
    up to 1month after surgery
    Title
    concentration of matrix metalloproteinase-9
    Time Frame
    up to 1month after surgery
    Secondary Outcome Measure Information:
    Title
    Correlation Between Inflammatory Mediators and Ocular Surface Changes
    Time Frame
    up to 1month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: minimum age of 18 years(range from 18 year to 25 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 41.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery Exclusion Criteria: systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xingwu Zhong, MD PhD
    Organizational Affiliation
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26937680
    Citation
    Zhang C, Ding H, He M, Liu L, Liu L, Li G, Niu B, Zhong X. Comparison of Early Changes in Ocular Surface and Inflammatory Mediators between Femtosecond Lenticule Extraction and Small-Incision Lenticule Extraction. PLoS One. 2016 Mar 3;11(3):e0149503. doi: 10.1371/journal.pone.0149503. eCollection 2016.
    Results Reference
    derived

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    Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction

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