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Early Changes Among FLEx, LASIK and FS-LASIK

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ClinicalTrials.gov Identifier: NCT02551796
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Xingwu Zhong, MD PhD, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Procedure: lenticule extraction Procedure: laser in situ keratomileusis Procedure: FS assisted laser in situ keratomileusis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: lenticule extraction
The patients in this group chose to receive the lenticule extraction surgery.
Procedure: lenticule extraction
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.
Other Names:
  • 0.3% tobramycin/dexamethasone (TobraDex, Alcon)
  • 0.5% levofloxacin (Cravit, Santen)
  • sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)

Experimental: laser in situ keratomileusis
The patients in this group chose to receive the laser in situ keratomileusis surgery.
Procedure: laser in situ keratomileusis
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.
Other Names:
  • 0.3% tobramycin/dexamethasone (TobraDex, Alcon)
  • 0.5% levofloxacin (Cravit, Santen)
  • sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)

Experimental: FS assisted laser in situ keratomileusis
The patients in this group chose to receive the FS assisted laser in situ keratomileusis surgery.
Procedure: FS assisted laser in situ keratomileusis
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.
Other Names:
  • 0.3% tobramycin/dexamethasone (TobraDex, Alcon)
  • 0.5% levofloxacin (Cravit, Santen)
  • sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)




Primary Outcome Measures :
  1. scale of Schirmer I test [ Time Frame: up to 1month after surgery ]
  2. scale of corneal fluorescein staining [ Time Frame: up to 1month after surgery ]
  3. scale of noninvasive tear breakup time [ Time Frame: up to 1month after surgery ]
  4. questionnaire of ocular surface disease index [ Time Frame: up to 1month after surgery ]
  5. scale of central corneal sensitivity [ Time Frame: up to 1month after surgery ]
  6. scale of tear meniscus height [ Time Frame: up to 1month after surgery ]
  7. concentration of Interleukin-1α [ Time Frame: up to 1month after surgery ]
  8. concentration of tumor necrosis factor-α [ Time Frame: up to 1month after surgery ]
  9. concentration of nerve growth factor [ Time Frame: up to 1month after surgery ]
  10. interferon-γ [ Time Frame: up to 1month after surgery ]
  11. concentration of transforming growth factor-β1 [ Time Frame: up to 1month after surgery ]
  12. concentration of matrix metalloproteinase-9 [ Time Frame: up to 1month after surgery ]

Secondary Outcome Measures :
  1. Correlation between Interleukin-1α and ocular surface disease index [ Time Frame: up to 1month after surgery ]
  2. Correlation between tumor necrosis factor-α and ocular surface disease index [ Time Frame: up to 1month after surgery ]
  3. Correlation between nerve growth factor and ocular surface disease index [ Time Frame: up to 1month after surgery ]
  4. Correlation between interferon-γ and ocular surface disease index [ Time Frame: up to 1month after surgery ]
  5. Correlation between transforming growth factor-β1 and ocular surface disease index [ Time Frame: up to 1month after surgery ]
  6. Correlation between matrix metalloproteinase-9 and ocular surface disease index [ Time Frame: up to 1month after surgery ]
  7. Correlation between Interleukin-1α and corneal fluorescein staining [ Time Frame: up to 1month after surgery ]
  8. Correlation between tumor necrosis factor-α and corneal fluorescein staining [ Time Frame: up to 1month after surgery ]
  9. Correlation between nerve growth factor and corneal fluorescein staining [ Time Frame: up to 1month after surgery ]
  10. Correlation between interferon-γ and corneal fluorescein staining [ Time Frame: up to 1month after surgery ]
  11. Correlation between transforming growth factor-β1 and corneal fluorescein staining [ Time Frame: up to 1month after surgery ]
  12. Correlation between matrix metalloproteinase-9 and corneal fluorescein staining [ Time Frame: up to 1month after surgery ]


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Ages Eligible for Study:   18 Years to 31 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551796


Locations
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China, Hainan
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
Haikou, Hainan, China, 570311
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Xingwu Zhong Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

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Responsible Party: Xingwu Zhong, MD PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02551796     History of Changes
Other Study ID Numbers: 2015-001
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Keywords provided by Xingwu Zhong, MD PhD, Sun Yat-sen University:
lenticule extraction
laser in situ keratomileusis
femtosecond laser-assisted laser in situ keratomileusis
tear
inflammatory mediators
Additional relevant MeSH terms:
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Astigmatism
Antiemetics
Refractive Errors
Eye Diseases
Levofloxacin
Ofloxacin
Tobramycin
Tobramycin, Dexamethasone Drug Combination
Dexamethasone
Dexamethasone acetate
BB 1101
Hyaluronic Acid
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors