Early Changes Among FLEx, LASIK and FS-LASIK

NCT02551796 | Completed

• 1 other identifier: 2015-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Keywords

lenticule extraction; laser in situ keratomileusis; femtosecond laser-assisted laser in situ keratomileusis; tear; 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

• 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 (12)

• Correlation between Interleukin-1α and ocular surface disease index

  up to 1month after surgery

• Correlation between tumor necrosis factor-α and ocular surface disease index

  up to 1month after surgery

• Correlation between nerve growth factor and ocular surface disease index

  up to 1month after surgery

• Correlation between interferon-γ and ocular surface disease index

  up to 1month after surgery

• Correlation between transforming growth factor-β1 and ocular surface disease index

  up to 1month after surgery

Study Arms (3)

lenticule extraction

EXPERIMENTAL

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

Procedure: lenticule extraction

laser in situ keratomileusis

EXPERIMENTAL

The patients in this group chose to receive the laser in situ keratomileusis surgery.

Procedure: laser in situ keratomileusis

FS assisted laser in situ keratomileusis

EXPERIMENTAL

The patients in this group chose to receive the FS assisted laser in situ keratomileusis surgery.

Procedure: FS assisted laser in situ keratomileusis

Interventions

lenticule extraction PROCEDURE

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.

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

lenticule extraction

laser in situ keratomileusis PROCEDURE

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.

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

laser in situ keratomileusis

FS assisted laser in situ keratomileusis PROCEDURE

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.

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

FS assisted laser in situ keratomileusis

Eligibility Criteria

• Age: 18 Years - 31 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 31 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 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

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

Study Sites (1)

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Haikou, Hainan, 570311, China

Location

MeSH Terms

Conditions

Myopia; Astigmatism; Lacerations

Interventions

Tobramycin; Dexamethasone; Tobramycin, Dexamethasone Drug Combination; methylacetylene; Levofloxacin; Hyaluronic Acid; Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Wounds and Injuries

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; Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Xingwu Zhong

  Hainan Eye Hospital, Zhongshan Ophthalmic Center of 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: September 13, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CN (1)