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Early Changes Among FLEx, LASIK and FS-LASIK

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lenticule extraction
laser in situ keratomileusis
FS assisted laser in situ keratomileusis
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 lenticule extraction, laser in situ keratomileusis, femtosecond laser-assisted laser in situ keratomileusis, tear, inflammatory mediators

Eligibility Criteria

18 Years - 31 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • minimum age of 18 years(range from 18 year to 31 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 42.0 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

  • Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

lenticule extraction

laser in situ keratomileusis

FS assisted laser in situ keratomileusis

Arm Description

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

The patients in this group chose to receive the laser in situ keratomileusis surgery.

The patients in this group chose to receive the FS assisted laser in situ keratomileusis 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
interferon-γ
concentration of transforming growth factor-β1
concentration of matrix metalloproteinase-9

Secondary Outcome Measures

Correlation between Interleukin-1α and ocular surface disease index
Correlation between tumor necrosis factor-α and ocular surface disease index
Correlation between nerve growth factor and ocular surface disease index
Correlation between interferon-γ and ocular surface disease index
Correlation between transforming growth factor-β1 and ocular surface disease index
Correlation between matrix metalloproteinase-9 and ocular surface disease index
Correlation between Interleukin-1α and corneal fluorescein staining
Correlation between tumor necrosis factor-α and corneal fluorescein staining
Correlation between nerve growth factor and corneal fluorescein staining
Correlation between interferon-γ and corneal fluorescein staining
Correlation between transforming growth factor-β1 and corneal fluorescein staining
Correlation between matrix metalloproteinase-9 and corneal fluorescein staining

Full Information

First Posted
September 13, 2015
Last Updated
June 13, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02551796
Brief Title
Early Changes Among FLEx, LASIK and FS-LASIK
Official Title
Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Among Lenticule Extraction, Laser in Situ Keratomileusis and Femtosecond Laser-assisted Laser in Situ Keratomileusis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (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
To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.
Detailed Description
Laser in situ keratomileusis (LASIK) with a microkeratome has been accepted wildly in the past 20 years. Gradually, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap. 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. This prospective clinical study is going to analyze the short-term changes in ocular surface measures and tear inflammatory mediators after FLEx, LASIK and FS-LASIK procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
lenticule extraction, laser in situ keratomileusis, femtosecond laser-assisted laser in situ keratomileusis, tear, 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
75 (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
laser in situ keratomileusis
Arm Type
Experimental
Arm Description
The patients in this group chose to receive the laser in situ keratomileusis surgery.
Arm Title
FS assisted laser in situ keratomileusis
Arm Type
Experimental
Arm Description
The patients in this group chose to receive the FS assisted laser in situ keratomileusis 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 will be 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 is released, the flap will be opened using a thin, blunt spatula and the free refractive lenticule will be subsequently grasped with a forceps and extracted, after which the flap will be repositioned carefully.
Intervention Type
Procedure
Intervention Name(s)
laser in situ keratomileusis
Other Intervention Name(s)
0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
Intervention Description
During LASIK surgery, the eye will be gently proptosed and a hinged corneal flap will be cut using a microkeratome. The flap will be lifted and the stromal bed will receive a 6 mm diameter and stroma ablation. Finally reposition the flap carefully.
Intervention Type
Procedure
Intervention Name(s)
FS assisted laser in situ keratomileusis
Other Intervention Name(s)
0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)
Intervention Description
Track distance and spot distance will be 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter will be 8.0 mm, and flap thickness will be set to 105 μm. Side-cut angle and hinge angle will be 90°and 50° respectively. The flaps will be created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system will be used in the subsequent ablation of thstromal bed with a 6.0 mm optical zone. Once the excimer. ablation is completed, the flap will be repositioned in a similar fashion as in routine LASIK.
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
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 Interleukin-1α and ocular surface disease index
Time Frame
up to 1month after surgery
Title
Correlation between tumor necrosis factor-α and ocular surface disease index
Time Frame
up to 1month after surgery
Title
Correlation between nerve growth factor and ocular surface disease index
Time Frame
up to 1month after surgery
Title
Correlation between interferon-γ and ocular surface disease index
Time Frame
up to 1month after surgery
Title
Correlation between transforming growth factor-β1 and ocular surface disease index
Time Frame
up to 1month after surgery
Title
Correlation between matrix metalloproteinase-9 and ocular surface disease index
Time Frame
up to 1month after surgery
Title
Correlation between Interleukin-1α and corneal fluorescein staining
Time Frame
up to 1month after surgery
Title
Correlation between tumor necrosis factor-α and corneal fluorescein staining
Time Frame
up to 1month after surgery
Title
Correlation between nerve growth factor and corneal fluorescein staining
Time Frame
up to 1month after surgery
Title
Correlation between interferon-γ and corneal fluorescein staining
Time Frame
up to 1month after surgery
Title
Correlation between transforming growth factor-β1 and corneal fluorescein staining
Time Frame
up to 1month after surgery
Title
Correlation between matrix metalloproteinase-9 and corneal fluorescein staining
Time Frame
up to 1month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: minimum age of 18 years(range from 18 year to 31 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 42.0 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
Organizational Affiliation
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China

12. IPD Sharing Statement

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Early Changes Among FLEx, LASIK and FS-LASIK

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