Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction

NCT02540785 | Completed

• 1 other identifier: 2014-005
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia; Astigmatism

Keywords

Refractive Surgical Procedures; small-incision lenticule extraction; lenticule extraction; inflammatory mediators

Outcome Measures

Primary Outcomes (12)

• scale of Schirmer I test

  up to 1month after surgery

• scale of corneal fluorescein staining

  up to 1month after surgery

• scale of noninvasive tear breakup time

  up to 1month after surgery

• questionnaire of ocular surface disease index

  up to 1month after surgery

• scale of central corneal sensitivity

  up to 1month after surgery

• scale of tear meniscus height

  up to 1month after surgery

• concentration of Interleukin-1α

  up to 1month after surgery

• concentration of tumor necrosis factor-α

  up to 1month after surgery

• concentration of nerve growth factor

  up to 1month after surgery

• concentration of interferon-γ

  up to 1month after surgery

• concentration of transforming growth factor-β1

  up to 1month after surgery

• concentration of matrix metalloproteinase-9

  up to 1month after surgery

Secondary Outcomes (1)

• Correlation Between Inflammatory Mediators and Ocular Surface Changes

  up to 1month after surgery

Study Arms (2)

lenticule extraction

EXPERIMENTAL

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

Procedure: lenticule extraction

small-incision lenticule extraction

EXPERIMENTAL

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

Procedure: small-incision lenticule extraction

Interventions

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

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

lenticule extraction

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

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

small-incision lenticule extraction

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (1)

• 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.

  PMID: 26937680 DERIVED

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Tobramycin; Dexamethasone; Tobramycin, Dexamethasone Drug Combination; methylacetylene; Levofloxacin; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Combinations; Pharmaceutical Preparations; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycosaminoglycans; Polysaccharides

Study Officials

• Xingwu Zhong, MD PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 4, 2015
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 28, 2016

Record last verified: 2016-11