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Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis

Primary Purpose

Myopia, Astigmatism

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

Eligibility Criteria

18 Years - 30 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 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 Type

Experimental

Experimental

Arm Label

lenticule extraction

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 femtosecond laser-assisted laser in situ keratomileusis surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation Between Inflammatory Mediators and Ocular Surface Changes

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
NCT02550353
Brief Title
Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis
Official Title
Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Between Lenticule Extraction 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
March 2016 (Actual)
Study Completion Date
May 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
The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.
Detailed Description
Over the past few years, 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 assess the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser in situ keratomileusis (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, 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
FS assisted laser in situ keratomileusis
Arm Type
Experimental
Arm Description
The patients in this group chose to receive the femtosecond laser-assisted laser in situ keratomileusis surgery.
Intervention Type
Procedure
Intervention Name(s)
lenticule extraction
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)
femtosecond laser-assisted laser in situ keratomileusis
Intervention Description
track distance and spot distance were 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter was 8.0 mm, and flap thickness was set to 105 μm. Side-cut angle and hinge angle were 90°and 50° respectively. The flaps were created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system was used in the subsequent ablation of the stromal bed with a 6.0 mm optical zone. Once the excimer ablation was completed, the flap was repositioned in a similar fashion as in routine LASIK.
Primary Outcome Measure Information:
Title
Schirmer I test
Time Frame
up to 1month after surgery
Title
corneal fluorescein staining
Time Frame
up to 1month after surgery
Title
noninvasive tear breakup time
Time Frame
up to 1month after surgery
Title
ocular surface disease index
Time Frame
up to 1month after surgery
Title
central corneal sensitivity
Time Frame
up to 1month after surgery
Title
tear meniscus height
Time Frame
up to 1month after surgery
Title
Interleukin-1α
Time Frame
up to 1month after surgery
Title
tumor necrosis factor-α
Time Frame
up to 1month after surgery
Title
nerve growth factor
Time Frame
up to 1month after surgery
Title
interferon-γ
Time Frame
up to 1month after surgery
Title
transforming growth factor-β1
Time Frame
up to 1month after surgery
Title
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
30 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 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
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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Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis

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