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
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
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
NCT ID
NCT02540785
First Posted
August 31, 2015
Last Updated
November 24, 2016
Sponsor
Sun Yat-sen University
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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