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Completed

NCT Number: NCT02540785

Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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For both FLEx and SMILE, stromal ablation has been replaced by refractive lenticule removal.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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lenticule extraction

Procedure

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

Other names: 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)

small-incision lenticule extraction

Procedure

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

Other names: 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)

Primary outcomes

  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. concentration of 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 outcomes

  1. Correlation Between Inflammatory Mediators and Ocular Surface Changes

    Time frame: up to 1month after surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Between Lenticule Extraction and Small-Incision Lenticule Extraction

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2015
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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